Study design
A two parallel-group, mixed methods, pilot randomized controlled trial was conducted in two large (Toronto, and London) and one small (Pembroke) urban centre in Ontario, Canada from March 2017 to April 2019. Research ethics approval was obtained at each hospital site and the University of Toronto. Our reporting follows the CONSORT guideline [30]. A qualitative descriptive approach [31] was used to complement quantitative data to evaluate the feasibility and acceptability of the study protocol and effects of the exercise program.
Eligibility and recruitment
In each urban centre, a hospital with designated stroke rehabilitation beds and a physical therapist willing to serve as a healthcare partner formed a partnership with a recreation centre. Hospital managers identified a registered physical therapist with at least one year of experience treating people with stroke and invited them to fulfil the role of the healthcare partner. Healthcare partners were expected to attend fitness instructor training sessions, train volunteers (where available), observe five TIMETM classes in a 24-class session and provide a 15-minute debrief to fitness instructors after the observed class. Recreation centres that were located within 50 km of the hospital to facilitate healthcare partner visits, fully accessible, in close proximity to public transport, with an appropriately-sized multi-purpose room, and recreation programming for all ages and abilities, were considered eligible. Recreation managers identified three fitness instructors meeting the following criteria: group fitness instructor certifications, including CanFitPro™ Fitness Instructor Specialist, YMCA-Fitness Leadership, Ontario Fitness Council (OFC), American Council on Exercise (ACE), or equivalent; excellent communication and leadership skills; empathy, enthusiasm and a genuine interest in working with people with disability; and two volunteers to assist with set-up and takedown of equipment, and supervise exercises in the walking station. Healthcare and recreation staff participating in the study provided signed informed consent.
The principal investigator (author NMS) and a TIMETM expert (author JH) conducted separate orientation meetings with each hospital and recreation provider. Meetings involved viewing a video of the TIMETM program [32], reviewing study documentation, including “Facts about TIMETM” [28], an article on safety, feasibility and potential benefit of TIMETM [18], list of equipment and resource needs, license and participant waiver, a list of research team members, 1-page study summary, a list of costs covered by the grant, and the study timeline.
The target population was ambulatory adults living in the community post-stroke. Inclusion criteria were: 1) clinical diagnosis of stroke documented in the health record; 2) age ≥ 18 years; 3) living at home for at least 3 months post-hospitalization for stroke to allow sufficient time to transition to community living; 4) self-reported ability to walk ≥10 metres with or without walking aids without assistance from another person; 5) ability to follow verbal instructions and speak and read English as judged by the recruiter; and 6) willingness to sign a liability waiver verifying medical clearance from a healthcare provider, and noting that TIMETM was intended as a wellness program, not as rehabilitation or physical therapy. Exclusion criteria were: 1) self-reported involvement in another exercise or rehabilitation program; 2) self-reported conditions or symptoms (e.g., unstable cardiovascular disease, significant joint pain) preventing exercise participation; 3) cognitive or behavioural deficits that would prevent cooperation within a group, as judged by the recruiter; 4) self-reported ability to walk ≥20 minutes without a seated rest; and 5) self-reported ability to manage environmental barriers (curbs, ramps, and stairs) with relative ease.
Caregivers of consenting participants were considered eligible if they: 1) helped the individual post-stroke to live at home and provided support and assistance with at least one basic and /or instrumental ADLs at least once a week [33]; and 2) were able to speak and read English. Paid personal support workers were excluded.
Recruitment strategies were hospital-dependent. In Toronto, prospective and retrospective recruitment methods were used. A physical therapist distributed study brochures to in- and outpatients and their caregivers (March-September 2017) and screened for eligibility at the time of discharge. Another physical therapist contacted discharged outpatients seen October 2016-January 2017 by phone to screen for eligibility and gauge interest to participate. The Toronto-based study coordinator followed up by phone to obtain verbal informed consent, and scheduled baseline evaluations. In Pembroke, a nurse practitioner on the stroke team contacted individuals with stroke who received outpatient rehabilitation between January 2016 and January 2017 by phone, mailed brochures and consent forms to interested individuals and caregivers, obtained verbal informed consent, and scheduled baseline evaluations. In London, a research assistant contacted individuals with stroke who were inpatients or outpatients January 2016 to June 2017 by phone and mail, obtained verbal informed consent, and scheduled baseline evaluations. Individuals with stroke and caregivers provided written informed consent at the baseline evaluation.
Data collection
Both quantitative and qualitative data were collected to address all study objectives. Trained evaluators, blinded to study hypotheses and group assignment, completed evaluations at 0, 3, 6, and 12 months at the hospital site. Coordinators made at least three attempts to schedule an evaluation at each time point. After baseline, participants were given the choice of completing self-report measures at home with each follow-up evaluation to reduce the length of the in-person evaluation.
Primary outcome: Everyday function was assessed using the Subjective Index of Physical and Social Outcome (SIPSO) [34] and the Nottingham Extended Activities of Daily Living (NEADL) [35]. The SIPSO is a 10-item self-report questionnaire comprising two 5-item subscales developed to capture physical (e.g., dressing, daily activities at home) and social (e.g., communication, satisfaction with friendships) integration post-stroke [34]. Participants score each activity from 0 to 4 where a higher score indicates a better level of integration. Subscale and total scores can range from 0 to 20 and 0 to 40, respectively. In community-dwelling people with stroke, intraclass correlation coefficient (ICC) values were 0.91 indicating excellent test-reliability of subscale and total scores. Correlations of scores on the SIPSO and the Barthel Index, Frenchay Activities Index, and Wakefield Depression Inventory ranging from 0.73 to 0.80 support the construct validity of SIPSO [34].
The NEADL is a 22-item, self-report measure of IADL performance with 4 scales: mobility, kitchen, domestic, and leisure. Item-level scores range from 0 to 3 where 0 indicates “unable” and 3 indicates “on my own”. Total scores can range from zero to 66. Spearman correlations of repeated measures using the subscales and total score ranging from 0.83 to 0.93 indicate a high level of test-retest reliability [36] and correlations of 0.88-0.90 with scores on the Barthel Index and Frenchay Activities Index provide evidence of construct validity in community-dwelling people with stroke [37].
Explanatory outcomes: Balance, balance self-efficacy, lower limb strength, walking distance, comfortable walking speed, cognition, and depression were evaluated using the Berg balance scale (BBS) [38], activities-specific balance confidence (ABC) scale [39], 30-second timed sit-to-stand test (30-STS) [40], 6-minute walk test (6MWT) [41, 42], 10-metre walk test (10mWT) [43], trail making test (TMT) [44], and geriatric depression scale-short version (GDS) [45], respectively.
Secondary outcomes: Lifespace mobility and independence with basic ADL were evaluated using the Lifespace Assessment (LSA) [46], and the 10-item Barthel Index (BI) [47] respectively. HRQL was evaluated using the Stroke Impact Scale (SIS) [48], and the Euroqol-5D-5L (EQ-5D-5L) [49, 50], respectively. The Lifespace Assessment scale assesses how far and how often individuals have mobilized in their immediate and distant living environment within the past 4 weeks. The EQ-5D-5L captures dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and converts to a single index value that can be used to calculate quality-adjusted life years (QALYs). A visual analog scale (EQ-VAS) yields a rating of current health that can range from 0 to 100 points. Caregiver assistance was assessed using the 17-item, self-report Caregiver Assistance Scale (CAS) [51, 52]. Caregiver emotional health was evaluated using the Research ANd Development-36 (RAND-36) emotional well-being and energy/fatigue score [53]. An injurious fall was defined as “an unexpected event in which the participant comes to rest on the ground, floor, or lower-level” [54] which results in an injury requiring medical care [55]. Participants were provided with monthly falls log calendars, and asked to record the occurrence of falls. The study coordinator or the evaluators contacted participants monthly to identify fall occurrence and determine if the fall led to injury requiring medical care. This approach is the gold standard method to prospectively evaluate falls [54]. At each evaluation, participants were asked to report on participation in co-interventions (e.g., physical therapy, alternate exercise classes) since the last evaluation.
At baseline, we collected data on participant age, sex, education level, employment status, income level, presence of caregiver, side of stroke, time post-stroke, comorbidity (Charlson comorbidity Index [56]), frailty (Canadian study of health and aging frailty scale [57]), type of mobility aids and orthoses used, as well as age, sex, role, employment status, and time spent caregiving of participating caregivers.
Intervention fidelity was evaluated by documenting implementation of TIMETM program elements, including the license, training (instructors, healthcare partners, volunteers), class frequency/duration, exercise class components (warm-up, specific exercises, cool down, recommended equipment, participant-to-instructor ratio), and healthcare partner visits. Fitness instructors documented adverse events that occurred during exercise classes using a standardized form. Participant engagement was evaluated by documenting attendance
We invited exercise and caregiver participants to separately participate in site- and intervention- specific focus groups or interviews that lasted approximately 45 to 60 minutes by telephone after the three-month evaluation. The research coordinator (KB) conducted all interviews. KB is a female and has a Master of Arts degree in Human Kinetics and 6 years of experience in conducting qualitative research. Participants were asked about their experiences with recruitment, evaluations, the exercise program (immeditate group), and waiting time (waitlist group), to understand the feasibility and acceptability of the study protocol and effects of the intervention. Sessions were digitally recorded, professionally transcribed verbatim, and reviewed for accuracy.
Randomization
Participants were stratified by site, and level of comfortable gait speed deficit (severe: ≤0.5 m/s; mild-moderate: >0.5 m/s) and block randomized to either the TIMETM program (i.e., immediate group) or the waitlist group in a 1-to-1 allocation ratio after the baseline evaluation. A Toronto-based research assistant, unfamiliar with participants, prepared a list of randomization assignments for each site by flipping a coin (block size of 2). The Toronto-based research assistant revealed group allocation to each participant by phone. We stratified by gait speed as it has been previously shown to modify the effect of task-oriented training on walking capacity post-stroke [27]. Blocking was used to balance the size of study groups to maximize statistical efficiency [58].
Intervention
The program involves two one-hour exercise classes per week for 12 weeks. Each one-hour class involves a seated warm-up, repetitive and progressive practice of functionally relevant balance and mobility tasks, and a seated cool down. Warm-up consists of active range-of-motion exercises, aerobic exercise, lower extremity weight bearing, stretching, and sit-to-stand training. The cool-down involves exercises similar to the warm-up but with an emphasis on stretching and relaxation. Participants, grouped by ability level, complete exercises organized in a 3-station circuit as follows: station 1: walking, aerobic training, and wall work (standing and reaching, wall push-ups); station 2: standing weight shifts, stepping and lunging; and station 3: tap-ups, step-ups, and heel/toe raises, hamstring curls, marching-on-the-spot, and mini-squats. Each exercise has several levels of challenge to enable tailoring. Instructors are asked to use their judgement to gauge readiness and safety of to move participants to more challenging levels. Instructors are advised to have participants exercise at an intensity of 3-4 (moderate to somewhat hard) on the modified Borg scale [59]. The class is modeled after task-oriented interventions delivered by healthcare professionals with evidence of safety, feasibility, and efficacy from randomized trials involving people post-stroke [16, 27, 60-62]. Caregivers of participants with severe motor deficits are encouraged to attend and assist during the class.
After signing the license, the recreation provider received an electronic toolkit with materials required to implement the program. Materials included the participant referral form and liability waiver, exercise guideline, equipment/resource list, and measures to use for program evaluation. TIMETM trainers delivered a 6-hour in-person training workshop with fitness instructors and healthcare partners that involved describing the program model, the roles of the partners, and movement challenges experienced by exercise class participants, and review and practice of the exercises including all levels of challenge. Volunteers were trained separately. They were asked to view a video of the TIMETM program, review the exercise guideline, and complete a 1.5 hour session with the healthcare partner or a fitness instructor to review the program, their role and responsibilities, and practice the exercises in the walking station.
Healthcare partners were instructed to visit the first 2 classes to advise fitness instructors on participant grouping, safety considerations and exercise modifications, and three more classes spread out over the remaining 11 weeks of the program, and address any questions from the fitness instructors by email or phone. The waitlist group received usual care, and were offered to participate in the 3-month exercise program following the final evaluation.
Sample size
A sample size of 20 participants and their caregivers if available per site for a total sample size of 60 was proposed. The exercise class runs with a group size of 8-12 participants. Thus, a sample size of 60 was considered sufficient to enable trialing of the exercise program in small and large urban centres with a similar group size to that planned for the exercise program in the definitive cross-Canada trial. A sample size of 30 participants per group provided 80% power to detect an effect size of 0.72 (given SD=1 for the SIPSO-Physical).
Analysis
Feasibility of recruitment was evaluated by computing site-specific recruitment rates (number recruited/recruitment period in months) and the percentage of caregivers agreeing to participate. Feasibility of retention and data collection was summarized using percentages of individuals in each group withdrawing, completing evaluations, and providing monthly falls data. Intervention fidelity was reported as the number of sites implementing program elements, the number and percentage of classes delivered, the percentage of classes in which the prescribed class-format (i.e., warm up, recommended exercises, cool-down) were followed. Participant engagement was determined by the percentage of classes attended. The number of participants receiving co-interventions was noted.
As this was a pilot study, we did not test hypotheses related to the effectiveness of the TIMETM program compared to usual care. Participant data were analyzed in the group to which participants were randomized. We summarized scores on each outcome measure by group using medians and 25th and 75th percentiles for continuous data and with frequencies and percentages for categorical data at each evaluation time point. The risk of injurious falls during TIMETM classes was estimated by computing the absolute risk difference (i.e., proportion of participants in the immediate group with an injurious fall minus proportion of participants in the waitlist group with an injurious fall). For a multi-item measure, if more than 10% of the items were missing data, the entire measure was considered missing. If ≤10% of items were missing, missing values were replaced by the average across other items in the scale and the total score was calculated. To identify the optimal measure of everyday function, we compared the effect size of ADL measures if data were normally distributed; otherwise, we examined change in scores from baseline to 3 months.
Transcripts were entered into NVivo to assist wtih the organization and analysis of the data. Using a directed content analysis [63], transcripts were coded based on the protocol element (i.e., recruitment, data collection, and interventions), or the effect of the intervention, using a deductive approach. Authors KB and NMS independently reviewed and coded two transcripts and then met to discuss coding. KB then coded the remaining transcripts using NVivo10. Rigor was optimized by triangulating results from participants and caregivers and quotations were used to support identified themes. Results from quantitative and qualitative analyses for each objective were compared and contrasted to enhance the rigor and robustness of the analysis.