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Adherence challenges and considerations 54

2.2   Method 42

2.2.2   Adherence challenges and considerations 54

Smoking abstinence was verified before the three acute exercise sessions by self-report and a breath CO Smokerlyzer (the Micro Smokerlyzer®; Bedfont Scientific) reading of less than six ppm (Middleton & Morice, 2000). The measurement of breath CO level provided an immediate, non-invasive, method of assessing smoking status. Carbon monoxide monitors are sufficient to detect recent smoking; CO has a half-life of about five to six hours (Middleton & Morice, 2000). Withdrawal symptoms pre- and post-exercise from participants who scored greater than six ppm breath carbon monoxide and/or reported smoking within the last 10 hours were not included in the analyses.

Although, CO measurement is acceptable it would have been prudent to also report salivary cotinine levels. Cotinine is a bi-product of nicotine and provides a more accurate representation of a smokers’ behaviour than CO. All participants who took part in the research contained in this dissertation provided salivary cotinine samples at baseline and week 14. Unfortunately, within the research time frame cotinine analyses were not received, and it is an acknowledged limitation of this dissertation as a whole.

2.2.2.2 Acute exercise heart-rate prescription

Although participants were cautiously introduced to exercise, the moderate and vigorous intensity did lead to discomfort for some of the women. Some women were not fond of sweating, working hard, or experiencing physical stiffness. To assist in alleviating stiffness and physical discomfort, research staff taught participants to properly warm-up prior to exercise, to cool down following an exercise session and to stretch. In addition, to promote appropriate exercise intensity,

research staff provided participants with a weekly exercise intensity goal at the beginning of each exercise session and remained visible throughout the exercise session.

As previously mentioned, exercise intensity was monitored and recorded using polar heart-rate monitors. For the vigorous acute exercise sessions, a few participants did not reach the exercise intensity goal (week 11 - n = 8; week 13 - n = 4 ) but engaged in at least moderate intensity exercise, or 50-60% of their HRR (CSEP). These data were included in the analyses. Therefore, not all participants engaged in vigorous intensity exercise although it was asked of them.

2.2.2.3 Nicotine replacement therapy

Prior to week four, participants were aware of the NicoDerm® 10 week NRT protocol and which programme they were going to undertake (two step programme or three step programme). Before starting the patch, participants were told to read the booklet provided in the NicoDerm® box and call the NicoDerm® 1-800 number with questions and concerns.

To facilitate compliance with the NRT protocol, the appropriate patches were distributed to each participant in weekly batches. Compliance with the NicoDerm® protocol was monitored via the completion of daily logs by participants. Recorded on the log was the time of day a new patch was administered, when patches were removed, any deviation from the 10 week NRT programme and any problems or concerns. At the beginning of each week, log sheets from the prior week were submitted to research staff and discussed with the participant.

Failure to follow the NicoDerm® 10 week patch programme generally stemmed from one of three themes: (1) the misconception that the

patch eliminated all cigarette withdrawal symptoms or withdrawal symptoms being misinterpreted as incorrect nicotine patch strength; (2) the sense of eagerness to be finished using nicotine; or (3) sleep disturbance or vivid dreams. Reluctance to follow protocol was countered with the fact that smoking cessation is more likely when pharmacotherapy is used as a part of the quit attempt (TTS, 2010) and with the fact that smoking cessation using the NRT patch is highest when proper NRT protocol is followed (TTS, 2010). Of the participants who reported sleep disturbances, many persevered with 24 hour patch use until the disturbances decreased or until the end of the 10 week programme. However, 36 of the 119 participants opted to take the patch off while sleeping. These participants were warned that nicotine levels will be decreased in the morning and withdrawal symptoms and cravings may be higher. Data from these individuals were included in the analyses if the participants met the smoking abstinence and exercise intensity requirements.

One participant (n = 1) a very heavy smoker, reported using self- purchased patches in addition to the NRT provided by researchers. This participant followed the NicoDerm® three step programme twice, concurrently (i.e., two patches per day). Data from this individual were included in the analyses if the participant met the appropriate smoking abstinence and exercise intensity requirements.

One participant (n = 1) reported an ‘allergy’ to the NicoDerm® brand NRT patches. To satisfy this individual, researchers provided her with the Life® brand NRT patches (i.e., 21mg, 14mg and 7mg). This individual followed the NicoDerm® protocol using Life® brand NRT patches. Data from this individual were included in the analyses if the participant met the appropriate smoking abstinence and exercise intensity requirements.

Participants who did not wear the patch daily and/or did not ‘step down’ at the proper time (week 11, week 13) were removed from subsequent analyses. Withdrawal and craving data for the participants who completed the two step 10 week NRT programme were analysed separately from the participants who completed the three step protocol for week five (n = 14) and week 11 (n = 9). No differences were revealed between the two protocols, hence the data were combined. Participants who did the two step patch protocol did not provide week 13 withdrawal and craving data because they did not decrease patch nicotine at that time.

2.2.2.4 Participant retention

Although no costs were incurred by the participants for the use of the exercise equipment, NRT, or for campus parking, retention of participants for 14 weeks was a challenge. Despite contacting participants via telephone and email to keep them in the trial, participant drop-out still occurred. See the flow chart for a schedule of participant drop-out (Figure 2.1). Participants who dropped out prior to week 14 assessments and/or did not attend week 14 assessments were considered to be smoking post-intervention.

Due to attrition, absenteeism and/or smoking lapses from week to week, the number of participants fluctuated over the three acute exercise sessions (week five, n = 69; week 11, n = 37; week 13, n = 26) (Figure 2.1). A total of 20 participants engaged in all three acute exercise sessions.