Promoting Optimal Physical Exercise for Life (PROPEL): aerobic exercise and self-management early after stroke to increase daily physical activity-study protocol for a stepped-wedge randomised trial

Abstract

Introduction: Physical exercise after stroke is essential for improving recovery and general health, and reducing future stroke risk. However, people with stroke are not sufficiently active on return to the community after rehabilitation. We developed the Promoting Optimal Physical Exercise for Life (PROPEL) programme, which combines exercise with self-management strategies within rehabilitation to promote ongoing physical activity in the community after rehabilitation. This study aims to evaluate the effect of PROPEL on long-term participation in exercise after discharge from stroke rehabilitation. We hypothesise that individuals who complete PROPEL will be more likely to meet recommended frequency, duration and intensity of exercise compared with individuals who do not complete the programme up to 6 months post discharge from stroke rehabilitation.

Methods and analysis: Individuals undergoing outpatient stroke rehabilitation at one of six hospitals will be recruited (target n=192 total). A stepped-wedge design will be employed; that is, the PROPEL intervention (group exercise plus self-management) will be 'rolled out' to each site at a random time within the study period. Prior to roll-out of the PROPEL intervention, sites will complete the control intervention (group aerobic exercise only). Participation in physical activity for 6 months post discharge will be measured via activity and heart rate monitors, and standardised physical activity questionnaire. Adherence to exercise guidelines will be evaluated by (1) number of 'active minutes' per week (from the activity monitor), (2) amount of time per week when heart rate is within a target range (ie, 55%-80% of age-predicted maximum) and (3) amount of time per week completing 'moderate' or 'strenuous' physical activities (from the questionnaire). We will compare the proportion of active and inactive individuals at 6 months post intervention using mixed-model logistic regression, with fixed effects of time and phase and random effect of cluster (site).

Ethics and dissemination: To date, research ethics approval has been received from five of the six sites, with conditional approval granted by the sixth site. Results will be disseminated directly to study participants at the end of the trial, and to other stake holders via publication in a peer-reviewed journal.

Trial registration number: NCT02951338; Pre-results.

Keywords: Behaviour Change; Exercise; Physical Activity; Physiotherapy; Stroke.

Conflict of interest statement

Competing interests: AM holds a New Investigator Award from the Canadian Institutes of Health Research (MSH141983). DB holds a Canada Research Chair. AT is supported by a personnel award from the Heart and Stroke Foundation, Ontario Provincial Office (CS I 7468).

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1

Intervention allocation schedule. G1, G2, and so on are the 6-week long group aerobic exercise (GAE) or Promoting Optimal Physical Exercise for Life (PROPEL) groups. Each site should be able to complete eight groups per year; however, only seven groups will be completed in 2017 to allow for additional time at the start of the year to obtain research ethics approval, inter-institutional agreements and pilot implementation at all sites (see also figure 2). ‘0’ indicates that the site will complete GAE in that time period, whereas ‘1’ indicates that they will complete PROPEL. A simple randomisation procedure will be used to determine the time at which each site transitions from GAE to PROPEL. Sites will be allocated in order by drawing names from a hat; for example, the first site to be drawn will be site A, the second will be site B, and so on.

Figure 2

Hypothetical timeline for one participant. The exact timing of inpatient and outpatient rehabilitation will vary for each participant. The submaximal aerobic capacity test is completed during inpatient rehabilitation. After this point, the participant could participate in individual or open-group aerobic exercise during inpatient and outpatient rehabilitation (while waiting to be enrolled in the study intervention). The closed-group study intervention (group aerobic exercise (GAE) only or Promoting Optimal Physical Exercise for Life (PROPEL)) will likely start during outpatient rehabilitation, though some patients may start during inpatient rehabilitation. The participant will be enrolled in the study at the end of the study intervention, at which point cohort descriptors, the Short Self-Efficacy for Exercise (SSEE) scale and the Short Outcome Expectations for Exercise (SOEE) scale, will be collected. Activity monitoring will be conducted for 7 days continuously at three time points: (1) 1 month, (2) 4 months and (3) and 6 months after the end of the study intervention. The Barriers to Being Active Quiz (BBAQ) will be conducted at the 1-month postintervention time point.