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Recruitment issues in a randomized controlled exercise trial targeting wheelchair users.

ABSTRACT: This paper describes recruitment challenges and lessons learned in conducting a randomized controlled exercise trial in the absence of direct access to a clinical population. One-hundred thirty-five wheelchair users were enrolled in a home and community-based intervention to promote exercise adoption and maintenance. Over 44 months of recruitment, 355 individuals inquired about the study and 323 completed the screening process. Nearly half were determined ineligible (150/323, 46.4%), typically due to having restricted arm movement, cognitive impairment, or medical conditions that are contraindicated for unsupervised exercise. Respondents cited paid media advertisements and recruitment materials placed in health care providers' offices most frequently as being how they learned about the study. RCT participant recruitment, particularly in the absence of direct access to a clinical population, required far more time and resources than anticipated to achieve sufficient enrollment. Nurturing relations with key gatekeepers, creating a visible public profile, and maintaining ongoing recruitment activities were essential to success.

SUBMITTER: Nary DE

PROVIDER: S-EPMC3034787 | biostudies-literature | 2011 Mar

REPOSITORIES: biostudies-literature

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Recruitment issues in a randomized controlled exercise trial targeting wheelchair users.

Nary Dorothy E DE Froehlich-Grobe Katherine K Aaronson Lauren L

Contemporary clinical trials 20101027 2

This paper describes recruitment challenges and lessons learned in conducting a randomized controlled exercise trial in the absence of direct access to a clinical population. One-hundred thirty-five wheelchair users were enrolled in a home and community-based intervention to promote exercise adoption and maintenance. Over 44 months of recruitment, 355 individuals inquired about the study and 323 completed the screening process. Nearly half were determined ineligible (150/323, 46.4%), typically d ...[more]

PMID: 21035565

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Project description:INTRODUCTION:Cardiovascular and metabolic diseases are a growing concern for individuals with spinal cord injury (SCI). Physical inactivity contributes to cardiometabolic morbidity and mortality in the SCI population. However, previous studies have shown mixed results regarding the effects of exercise on cardiometabolic risk factors in individuals with SCI. This discrepancy could be influenced by insufficient exercise stimuli. Recent guidelines recommend 30 min of moderate-to-vigorous intensity aerobic exercise, three times per week, for improvement in cardiometabolic health in individuals with SCI. However, to date, no studies have implemented an exercise intervention matching the new recommendations to examine the effects on cardiometabolic risk factors. Therefore, the primary objective of this study is to determine the effects of 12 weeks of wheelchair user-modified upper-body rowing exercise on both traditional (constituents of the metabolic syndrome) and novel (eg, vascular structure and function) cardiometabolic risk factors in manual wheelchair users with SCI. METHODS AND ANALYSIS:A randomised controlled trial will compare 12 weeks of upper-body rowing exercise, 30 min three times per week, with a control group continuing their normal lifestyle. Outcome measurements will be performed immediately before (baseline), after 6 weeks (halfway), 12 weeks of training (post) and 6 months after the termination of the intervention period (follow-up). Outcomes will include inflammatory (eg, C reactive protein) and metabolic biomarkers determined from venous blood (with serum fasting insulin as primary outcome), body composition, arterial blood pressure, cardiorespiratory fitness level, brachial artery vascular structure and function and autonomic nervous system function. ETHICS AND DISSEMINATION:This trial is reported to the Danish Data Protection Agency (J.nr. 2019-899/10-0406) and approved by the Committees on Health Research Ethics in The North Denmark Region on 12 December 2019 (J.nr. N-20190053). The principal investigator will collect written informed consent from all participants prior to inclusion. Irrespective of study outcomes, the results will be submitted to peer-reviewed scientific journals for publication. TRIAL REGISTRATION NUMBER:NCT04390087.

Project description:BackgroundPhysical activity (PA) must be performed regularly to accrue health benefits. However, the majority of manual wheelchair users do not meet PA recommendations. Existing community-based PA programs for manual wheelchair users appear to work, but effect sizes are small and retention is low. Existing PA programs may not fully implement some psychosocial factors that are strongly linked with PA (eg, autonomy). The use of peers and mobile phone technology in the Smartphone Peer PA Counseling (SPPAC) program represents a novel approach to cultivating a PA-supportive environment for manual wheelchair users.ObjectiveThe primary objective is to compare change in objective PA between the experimental (SPPAC) and control groups from baseline to postintervention (10 weeks) and follow-up (3 months). Changes in and relationships between subjective PA, wheelchair skills, motivation, self-efficacy (for overcoming barriers to PA for manual wheelchair use), satisfaction of psychological needs for PA, and satisfaction with PA participation will be explored (secondary outcome). Program implementation will be explored (tertiary objective).MethodsA total of 38 community-living manual wheelchair users (≥18 years) will be recruited in a randomized controlled trial (RCT). Participants in both the control and experimental groups will receive existing PA guidelines. Participants in the experimental group will also receive the SPPAC program: 14 sessions (~30 min) over a 10-week period delivered by a peer trainer using a mobile phone. PA activities will be based on individuals' preferences and goals. Implementation of important theoretical variables will be enforced through a peer-trainer checklist. Outcomes for objective PA (primary) and subjective PA, wheelchair skills, motivation, self-efficacy, satisfaction of psychological needs, and satisfaction with participation will be collected at three time points (baseline, postintervention, follow-up). Multiple imputations will be used to treat missing data. A mixed-model ANCOVA will be conducted, controlling for covariates (primary and secondary objectives). The strength and direction of the relationships between the primary and secondary outcomes will be explored (secondary objective). Descriptive and content analysis will be used to appraise program implementation (tertiary objective).ResultsFunding has been obtained from the Craig Neilsen Foundation and the Canadian Disability Participation Project, with additional funds being sought from the Canadian Institute for Health Research and Fonds de Recherche du Québec-Santé. Pilot evaluation of intervention implementation is currently underway, with enrollment anticipated to begin early 2018.ConclusionsThere may be substantial benefits for the SPPAC program including limited burden on health care professionals, decreased barriers (eg. accessibility, transportation), development of peer social supports, and potential cost savings related to physical inactivity. Before conducting a large and expensive multisite RCT within a small heterogeneous population of manual wheelchair users, a pilot study affords a prudent step to establishing an adequate study protocol and implementation strategies.Trial registrationClinicalTrials.gov NCT02826707; https://clinicaltrials.gov/ct2/show/NCT02826707 (Archived by WebCite at http://www.webcitation.org/6pqIc14dU).

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Recruitment issues in a randomized controlled exercise trial targeting wheelchair users.

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Recruitment issues in a randomized controlled exercise trial targeting wheelchair users.

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