Top PDF The acute effects of aerobic exercise on sleep in patients with depression: study protocol for a randomized controlled trial

The acute effects of aerobic exercise on sleep in patients with depression: study protocol for a randomized controlled trial

The acute effects of aerobic exercise on sleep in patients with depression: study protocol for a randomized controlled trial

Adherence and other outcomes of interest We assess the implementation of the intervention with continuous measurement of Watts and heart rate using a Polar® H7 chest strap (Polar OY, Finland). We measure heart rate throughout the intervention period, including 3 min post-exercise. We measure perceived exertion using the Borg scale (6–20) [93]. All subjects complete a question- naire on their current mood immediately before and at the end of the control condition as well as the exercise intervention. The Befindlichkeitsskala has adequate psychometric properties [182] and is considerably more economical than other comparable measures [183]. The questionnaire consists of 40 items on a five-point Likert scale (not at all to very much). Items load onto eight subscales (with five items each): activity (Cronbach’s α = 0.82), elation (Cronbach’s α = 0.81), contemplation (Cronbach’s α = 0.70), calmness (Cronbach’s α = 0.78), fatigue (Cronbach’s α = 0.88), depression (Cronbach’s α = 0.80), anger (Cronbach’s α = 0.86), and excitement (Cronbach’s α = 0.73) [182]. Contamination through any or additional physical activity (depending on the allocation) is assessed using a wrist-worn accelerometer (on non-dominant hand) on the days prior to and after the sleep assessments. The wrist-worn accelerometer vivofit®2 (Garmin, Schaffhausen, Switzerland) validly assesses steps in various walking conditions [184]. Although adequate blinding cannot be achieved by design in exercise studies, this allows for a partial assessment of performance bias.
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Aerobic exercise program with or without motor complexity as an add on to the pharmacological treatment of depression – study protocol for a randomized controlled trial

Aerobic exercise program with or without motor complexity as an add on to the pharmacological treatment of depression – study protocol for a randomized controlled trial

Even though continuous aerobic exercise (CAE) seems to produce beneficial effects on depression and associ- ated comorbidities, recent studies have shown that phys- ical exercise with high motor complexity may produce additional benefits to overall health status. Specifically, exercise with high motor complexity may be particularly beneficial for patients with depression as it requires high levels of attention, memory, and motor difficulty, produ- cing greater cortical activation than exercises with low motor complexity (e.g., CAE) [23, 24]. Accordingly, high cortical activity (i.e., due to the integration of perceptual, motor, and cognitive information) has the potential to produce greater neuroplasticity [25] (i.e., changes in brain structure and function) than conditions requiring low cortical activity (low motor complexity). Recent studies from our group demonstrated that 3 months of an exercise program with high motor complexity pro- duced greater cognitive improvement in patients with Parkinson ’ s disease than exercises with low motor com- plexity [26]. In addition, hippocampal volume seems to increase after an exercise intervention with high motor complexity (i.e., coordinative exercises) [27]. This finding is particularly important as increases in hippocampal volume are associated with improved brain function, while decreases in hippocampal volume are related to depression symptoms [27].
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Effect of intermittent aerobic exercise on sleep quality and sleep disturbances in patients with rheumatoid arthritis – design of a randomized controlled trial

Effect of intermittent aerobic exercise on sleep quality and sleep disturbances in patients with rheumatoid arthritis – design of a randomized controlled trial

Cross-sectional studies have shown that physical inactiv- ity increases the likelihood of reporting poor sleep, even after controlling for age, depression and pain [25,26]. Fur- thermore, it has been reported that, independent of age and sex [27], maximal aerobic capacity is lower in patients with insomnia compared to those without it. In addition, physical exercise interventions have been shown to be a feasible and effective non-pharmacological treatment mo- dality for improving sleep in healthy and in clinical popula- tions [28-31]. Exercise interventions is known to improve cardiorespiratory fitness, muscle strength and functional ability [32], as well as health-related quality of life [33], and to reduce co-morbidity [34] in patients with RA. Thus, physical exercise interventions may be a viable non- pharmacological alternative for both prevention and treat- ment of poor sleep in addition to the simultaneous benefits for numerous health parameters in the human body.
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The effects of combined exercise intervention based on Internet and social media software for postoperative patients with breast cancer: study protocol for a randomized controlled trial

The effects of combined exercise intervention based on Internet and social media software for postoperative patients with breast cancer: study protocol for a randomized controlled trial

(2) The Patient Reported Outcome Measurement Information System [22] (PROMIS) will be used in the evaluation of physical function, anxiety, and depression of the individuals mainly, including physical functions (such as: can you run or do shopping?), anxieties during the past seven days (such as: I feel fearful), frustrating (such as: I feel useless), sleeping disorders (such as: I have trouble falling asleep), and pain disruptions (does pain limit your housekeeping activities?). The options are categorized into five levels from not at all/no/very weak as the first option to always/very much/very good as the fifth option. It has been demonstrated that PROMIS can be applied in the evaluation of the population of clinic patients [23].
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Effects of exercise training and photobiomodulation therapy (EXTRAPHOTO) on pain in women with fibromyalgia and temporomandibular disorder: study protocol for a randomized controlled trial

Effects of exercise training and photobiomodulation therapy (EXTRAPHOTO) on pain in women with fibromyalgia and temporomandibular disorder: study protocol for a randomized controlled trial

A key issue is the association of FM with other mus- culoskeletal comorbidities, such as temporomandibular dysfunction (TMD) [5]. It has been shown that TMD can develop as a result of mandibular compression dur- ing daily living activities and sleep in the patients with FM [5–7], in which the coexistence of these pathologies generates a clinical outcome of high complexity [8]. Un- fortunately, no published studies of patients with FM and TMD have evaluated an effective pharmacologic and/or nonpharmacologic therapeutic intervention. Pre- vious studies have examined only the role of different interventions in the situation of a pathology per se. In this issue, exercise training is highly recommended in the controlling of patients with FM. Aerobic, strength, and mixed training programs (combination of aerobic, strength, and flexibility) were shown to reduce pain, num- ber of tender points, fatigue, depression, and anxiety and to improve health-related quality of life as well as func- tional capacity [9, 10]. Exercises targeted for the face are also indicated for treatment of TMD as a procedure com- bined with other therapies (e.g., electrotherapy, physio- therapy, temporomandibular joint mobilization, and facial massage) to improve pain sensitivity [11–13].
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Effect of low level laser therapy on pain, quality of life and sleep in patients with fibromyalgia: study protocol for a double blinded randomized controlled trial

Effect of low level laser therapy on pain, quality of life and sleep in patients with fibromyalgia: study protocol for a double blinded randomized controlled trial

Fibromyalgia is often associated with other syndromes, such as fatigue, sleep disorders, morning stiffness and psychological disorders, such as anxiety and depression. Sleep disorders are closely linked to somatic symptoms in patients with fibromyalgia and not to their personal- ity. The most common complaints are difficulty falling asleep, frequent awakening during the night, difficulty getting back to sleep, restless superficial sleep and early rising, the consequences of which are nonrestorative sleep and a sensation of weariness, which contribute to- ward a poor quality of life. Thus, non-restorative sleep is an important aspect among the manifestations of fibro- myalgia, which makes the investigation into primary sleep disorders essential to the assessment of affected individuals [5,6]. The complexity of the factors involved regarding both diagnosis and adequate treatment under- scores the need for further studies aimed at broadening knowledge on the effects of this condition on patients.
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Cognitive behavioural therapy in elderly type 2 diabetes patients with minor depression or mild major depression: study protocol of a randomized controlled trial (MIND-DIA)

Cognitive behavioural therapy in elderly type 2 diabetes patients with minor depression or mild major depression: study protocol of a randomized controlled trial (MIND-DIA)

The power calculation is based on expected differences in SF-36 z-scores. Based on our own comparison of type 2 diabetes patients with mainly untreated depression ver- sus non-depressed patients, we assume differences of δ = 0.6 between CBT and TAU and of δ = 0.4 between CBT and SH. For the latter comparison, a significant difference can be detected with a power of 90% if n = 132 patients per intervention group are enrolled (2-sided t-test, α = 0.05). Given 132 patients in the CBT group, it is sufficient to enroll 51 patients in the TAU group to achieve a power of 95% for the comparison CBT vs. TAU. We therefore plan to recruit a total number of 315 patients (132 in CBT, 132 in SH, and 51 in TAU). We expect a rate of loss to follow-up of 20% in light of our experiences in the ongoing Depression and Diabetes (DAD) study and assuming that mortality will play a role in our sample because of the age of the patients. Analyses will be per- formed using an intent-to-treat principle (ITT) that includes all randomised subjects in the groups to which they were assigned. The last observation carried forward method (LOCF) will be used for the handling of missing data due to dropouts. The primary population for analy- sis is the ITT population. To fully appreciate the potential influences of missing responses and the LOCF method chosen as imputation procedure, additional sensitivity analyses examining the effects of different imputation methods will be performed and discussed.
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Effects of exercise and diet interventions on obesity related sleep disorders in men: study protocol for a randomized controlled trial

Effects of exercise and diet interventions on obesity related sleep disorders in men: study protocol for a randomized controlled trial

Methods/design: Participants consist of 330 (target sample) Finnish men aged 30 to 65 years. Among them, we attempt to randomize 180 (target sample) with sleep disorders into exercise and diet intervention. After screening and physician examination, 101 men with sleep disorders are included and are randomly assigned into three groups: exercise (n = 33), diet (n = 35), and control (n = 33). In addition, we attempt to recruit a target number of 150 healthy men without sleep disorders as the reference group. The exercise group undergoes a six-month individualized progressive aerobic exercise program based on initial fitness level. The diet group follows a six month specific individualized diet program. The control group and reference group are asked to maintain their normal activity and diet during intervention. Measurements are taken before and after the intervention. Primary outcomes include objective sleep measurements by polysomnography and a home-based non-contact sleep monitoring system, and subjective sleep evaluation by questionnaires. Secondary outcome measures include anthropometry, body composition, fitness, sleep disorder-related lifestyle risk factors, composition of gut microbiota and adipose tissue metabolism, as well as specific hormone and neurotranmitter levels and inflammatory
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Effects of transcranial LED therapy on the cognitive rehabilitation for diffuse axonal injury due to severe acute traumatic brain injury: study protocol for a randomized controlled trial

Effects of transcranial LED therapy on the cognitive rehabilitation for diffuse axonal injury due to severe acute traumatic brain injury: study protocol for a randomized controlled trial

DAI diagnosis is histopathological. It can be clinically de- fined by coma lasting 6 h or more after TBI, excluding cases of swelling or ischemic brain lesions [44, 45]. Focal brain injury may produce mass effects from hemorrhagic contu- sion or hematoma, which can induce herniation and brain stem compression, and the resultant may be coma, which is not usually immediate but develops in a secondary fashion. Otherwise, DAI can be a sole source of post-traumatic coma in the absence of mass lesions [45]. MRI will be per- formed in all patients for documentation. However, MRI cannot demonstrate DAI lesions in up to 10% of patients. Therefore, patients with Glasgow Coma Scale (GCS) ≤8 lasting more than 6 h without MRI or with normal CT or normal MRI will also be diagnosed as having DAI, if no other reasons justify the coma status [44–46]. Patients will be considered to have awakened from coma when they score 6 points in the best motor response in the GCS, con- sequently not being included in this protocol.
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Effect of high-flow nasal therapy during acute aerobic exercise in patients with chronic obstructive pulmonary disease after exacerbation: protocol for a randomised, controlled, cross-over trial

Effect of high-flow nasal therapy during acute aerobic exercise in patients with chronic obstructive pulmonary disease after exacerbation: protocol for a randomised, controlled, cross-over trial

for the variability of this estimation, the intensity of the initial CWRET will be adjusted if the TLim is less than 5 min or more than 15 min, and the intensity of work will be increased or decreased by 20%. Initially, the aim of the test will be to accustom the patient to the instructions. Then, the CWRET will be used to titrate the oxygen flow for patients on long-term oxygen therapy in order to achieve 90% SpO 2 during exercise. The same flow will be administered in all conditions (HFNT or oxygen alone) and will not be modified for the duration of the study. After 1-hour rest, the patient will be given familiarisation time with the HFNT during exercise (cycle ergometer) for 10 min.
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Effects of supervised aerobic and strength training in overweight and grade I obese pregnant women on maternal and foetal health markers: the GESTAFIT randomized controlled trial

Effects of supervised aerobic and strength training in overweight and grade I obese pregnant women on maternal and foetal health markers: the GESTAFIT randomized controlled trial

Methods/design: The present study aims to recruit 60 overweight and grade I obese women interested in participating in an exercise intervention program from the 17th gestational week until delivery. Women will be randomized to either an exercise (three 60-min sessions/week of combined aerobic and strength training and pelvic floor exercises), or usual care (control) group (30 women per group). The primary outcome measures are maternal weight gain, and maternal and neonatal glycaemic profile. Secondary outcome measures are: i) perinatal obstetric records; i) body composition; iii) dietary patterns; iv) physical fitness; v) low-back pain; vi) objectively measured physical activity and sedentary behaviour; vii) haematology and biochemical analyses; viii) oxidative stress; ix) pro- and anti-inflammatory markers; x) bone health biomarkers; xi) sleep quality; xii) mental health, quality of life and positive health.
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Effects of aerobic exercise on cognition and hippocampal volume in Alzheimer’s disease: study protocol of a randomized controlled trial (The FIT AD trial)

Effects of aerobic exercise on cognition and hippocampal volume in Alzheimer’s disease: study protocol of a randomized controlled trial (The FIT AD trial)

At least five meta-analyses of randomized controlled trials (RCTs) have been conducted demonstrating that aerobic exercise produced mild-to-moderate cognitive gains in adults without AD and dementias [8-12]. Similar cognitive improvements were found from aerobic exercise in per- sons with mild cognitive impairment (MCI) and dementia [13-16]. One meta-analysis even showed that aerobic exercise improved memory to a greater degree in persons with MCI (Hedges’ g = 0.237, P = .05) than in those without MCI (g = 0.096, P = .143) [12]. Together, these findings lend preliminary support to that aerobic exercise provides a therapeutic effect on cognition in AD, which is demonstrated by emerging aerobic exercise studies in AD. Cycling or walking for 5 to 12 weeks improved scores on the Mini-Mental State Examination (MMSE) from 16.3 at baseline to 19.8 post training (P < .001, n = 35) [17]. In another study, 15 men with AD increased scores on the Test of Attention Matrix from 35.9 to 43.0 and the MMSE from 19.4 to 21.7 from baseline to 3 months (all P < .001) after completing a 3-month moderate-intensity cycling intervention [18]. However, these studies did not have a control group.
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Effects of an aquatic physical exercise program on glycemic control and perinatal outcomes of gestational diabetes: study protocol for a randomized controlled trial

Effects of an aquatic physical exercise program on glycemic control and perinatal outcomes of gestational diabetes: study protocol for a randomized controlled trial

Obstetrical staff will identify pregnant women recently di- agnosed with GDM; following IMIP guidelines, a 75 g oral glucose tolerance test (OGTT) is routinely performed be- tween the 24th and 28th gestational week. These patients will be approached by a member of the study team and permission will be sought after an explanation of the study goals. GDM women will be considered eligible for enroll- ment if they fulfill all the inclusion criteria and none of the exclusion criteria. Interested patients will be invited to sign a written informed consent.

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Effects of aerobic exercise therapy and cognitive behavioural therapy on functioning and quality of life in amyotrophic lateral sclerosis: protocol of the FACTS-2-ALS trial

Effects of aerobic exercise therapy and cognitive behavioural therapy on functioning and quality of life in amyotrophic lateral sclerosis: protocol of the FACTS-2-ALS trial

First, the lack of substantial evidence regarding the role of AET and CBT in people with ALS supports the need to develop further high-quality, sufficiently pow- ered trials. The FACTS-2-ALS study design is a multi- centre, single-blinded, randomized controlled clinical trial with long-term follow-up. Patients will be followed up until 6 months after the intervention, which will not only provide information about the maintenance of the effects, but also about any long-term adverse events. We have deliberately chosen a biphasic randomization model with postponed information. This design will pre- vent patients being disappointed if they are randomized to the control group. Besides, if patients in the control group were fully informed, they might become moti- vated to seek a similar intervention. Moreover, disap- pointment may affect the way patients answer the questionnaires about their health and QoL, and conse- quently influence the study outcomes. A postponed information model can also be considered patient- friendly, as it provides all relevant information stripped of the theoretical and practical complexities of the study design. Moreover, there is no risk of damage caused by not informing the participants, who will be clearly informed at a later stage, with an explanation of the rea- son why this method was chosen.
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Effects of whole body vibration exercise on neuromuscular function for individuals with knee osteoarthritis: study protocol for a randomized controlled trial

Effects of whole body vibration exercise on neuromuscular function for individuals with knee osteoarthritis: study protocol for a randomized controlled trial

Various exercises have been recommended as potential treatments for KOA [42–45]. Given its feasibility and safety, WBV exercise has been recommended as an alter- native treatment to improve the function and self- reported disease status of individuals with KOA [12, 13, 46]. Furthermore, one study found no progression in the self-reported knee pain of a patient with KOA after 8 weeks of WBV training [26]. However, several studies failed to find significant improvements in pain intensity and functional performance [47, 48]. Recently, several sys- tematic reviews and meta-analyses investigated the thera- peutic effects of WBV exercise in individuals with KOA [12, 13, 49]. In general, evidence supports the notion that WBV exercise reduces pain and improves physical func- tions in individuals with KOA [12, 13]. Furthermore, no significant difference was found in the pain intensities and self-reported status of patients who performed WBV exer- cise and other exercises [49]. Currently, limited evidence is available to support the effect of WBV on patients with KOA. Considering the lack of data-appropriate RCTs, the American College of Rheumatology did not recommend WBV exercise as a treatment for KOA [9]. Therefore, well-designed RCTs are required to determine the thera- peutic effect of WBV exercise on individuals with KOA.
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Original Article Effect of aerobic and resistance exercise on liver enzyme and blood lipids in Chinese patients with nonalcoholic fatty liver disease: a randomized controlled trial

Original Article Effect of aerobic and resistance exercise on liver enzyme and blood lipids in Chinese patients with nonalcoholic fatty liver disease: a randomized controlled trial

In the study, subjects were enrolled from Jiangsu Province Hospital of Integration of Chinese and Western Medicine and Danyang central hospital, China. Inclusion criteria were consistent with the 2010 edition of guidelines for the diagnosis and treatment of NAFLD; with grade five muscle strength; without regular exercise; aged between 18 and 75 years; pa- tients were conscious and with the ability of communication. The exclusion criteria were identified as a variety of acute and chronic infections, cancer, and other immune diseases; serious acute and chronic diseases, such as acute cerebral infarction, lumbar disc her- niation; proliferative retinopathy; pregnant or lactating women; long term drinking history defined as a long history of alcohol consump- tion for more than 5 years, which was equiva- lent to the amount of male alcohol more than 140 g/weeks and the amount of female etha- nol greater than 70 g/weeks; had no history of viral and autoimmune hepatitis, and drug- induced liver diseases. Participants who did not take part in training more than two times a week and for whom telephone notification was
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Acute and chronic effects of aerobic exercise on blood pressure in resistant hypertension: study protocol for a randomized controlled trial

Acute and chronic effects of aerobic exercise on blood pressure in resistant hypertension: study protocol for a randomized controlled trial

For subjects with resistant hypertension, there are few studies involving physical exercise. Clinical trials [29–32] have identified significant reductions in SBP and DBP levels after 12 weeks of continuous moderate aerobic exer- cise training (based on lactate concentration) and strength training (resistance exercise in a pool). Recently, a cross- over trial investigated short-term exercise (mild and mod- erate intensity) effects in resistant hypertension and found significant reductions in both SBP and DBP levels at both intensities [33]. These studies show the importance of physical exercise as a therapeutic strategy for this popula- tion. However, it is still unclear which physical exercise characteristics can result in better outcomes in follow-up studies for patients with resistant hypertension, as well as the possible mechanisms linked to adjustments in BP levels. Exercise characteristics, such as intensity, duration, frequency and type, are associated with different BP re- sponses. Aerobic exercise intensity is a characteristic that seems to influence the magnitude and duration of PEH, but there is no consensus about the magnitude of hypotension and/or the intensity which is more effect- ive in reducing BP levels. Eicher et al. [34] reported that high-intensity interval-training exercise promotes PEH; however, other authors found that lower intensities have been more effective in reducing BP levels [35]. Therefore,
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Effectiveness of blood flow restricted exercise compared with standard exercise in patients with recurrent low back pain: study protocol for a randomized controlled trial

Effectiveness of blood flow restricted exercise compared with standard exercise in patients with recurrent low back pain: study protocol for a randomized controlled trial

For the three trunk extensor-related outcomes (i.e., size, strength, and endurance), we will compute a percentage change and will test a difference in group means using linear mixed-effects (LME) models with covariates in- cluded to increase the precision of effect-size estimation. To analyze LBP recurrence, we will compute the rate of LBP recurrence, average duration of a LBP episode, and intensity as the mean and maximum pain and disability scores over the follow-up period as well as during an episode of LBP occurrence. We will test whether the groups differ in these measures with LME models. We will assess potential bias due to loss to follow-up by examining whether characteristics measured at baseline and immediately following the training will predict attri- tion. We will perform exploratory intention-to-treat ana- lyses (ITT), of all randomized study participants who have baseline assessments and estimate parameters based on last observation carried forward as well as maximum likelihood estimation. We will also perform exploratory per-protocol analyses (PPA) where we will exclude study participants who (1) fail to attend 75 % of their exercise training sessions, (2) receive prohibited concomitant interventions, or (3) develop an exclusion- ary medical condition while on study protocol.
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The effects of using cognitive behavioural therapy to improve sleep for patients with delusions and hallucinations (the BEST study): study protocol for a randomized controlled trial

The effects of using cognitive behavioural therapy to improve sleep for patients with delusions and hallucinations (the BEST study): study protocol for a randomized controlled trial

Patients will be recruited from services across the Oxford Health NHS Foundation Trust, which covers a population of 1.1 million. We will seek referrals from all relevant outpatient and inpatient clinical teams who see patients with schizophrenia and related diagnoses. The inclusion criteria are: a current delusion or hallucination that has persisted for at least three months; a score of at least 2 on the distress scale of the Psychotic Symp- tom Rating Scales (PSYRATS) for either a delusion or hallucination [18]; a clinical diagnosis of schizophrenia, schizoaffective disorder or delusional disorder (that is, diagnosis of nonaffective psychosis (F2) in the Inter- national Classification of Diseases and Diagnostic and Statistical Manual IV); sleep difficulties lasting one month or longer with an ISI score of 15 or above (that is, above subthreshold insomnia). Participants must be aged between 18 and 65, and, where changes in medi- cation are being made, entry to the study would not occur until at least a month after stabilization of dos- age. It should be noted that we will be seeing patients
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Effects of high intensity aerobic exercise on psychotic symptoms and neurocognition in outpatients with schizophrenia: study protocol for a randomized controlled trial

Effects of high intensity aerobic exercise on psychotic symptoms and neurocognition in outpatients with schizophrenia: study protocol for a randomized controlled trial

The project is approved by the Regional Ethics Commit- tee of Southern and Eastern Norway (REK Sør-Øst) under file number 2014/372/REK SØR-ØST C. Trial registration has been carried out at ClinicalTrial.gov (NCT02205684). Informed and written consent is a pre- requisite for participation. Initial information about the study will be given to eligible patients by the regular staff during a routine appointment in the outpatient clinic, or by a project co-worker. Further detailed written and oral information about the trial will then be given by the project co-worker. It will be assured that participation is voluntary, that the participants can withdraw at any time point and will receive ordinary treatment whether they choose to participate or not. If the patient understands the nature of the research and is willing to participate, he or she will be asked to sign a consent form. The interviews in the trial will be completed in several encounters with the participant, and emphasis will be put on avoiding unnecessary strain on the individual and adjustment to own preferences. Similarly, when taking part in the treatment intervention, attention will be paid to the physical fitness of the participant. Potential alter- ation of the intensity and frequency of the physical activity will be adjusted individually over several weeks. Partici- pants experiencing discomfort or possible medical compli- cations while exercising on the treadmill will receive immediate necessary examination by medical staff in the unit. Positive as well as negative results will be published according to the Consolidated Standards of Reporting Trials (CONSORT) guidelines [75].
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