Fit for Dialysis: Research-based Film as a Knowledge Translation Strategy
1 other identifier
interventional
60
1 country
2
Brief Summary
Exercise training for older hemodialysis patients can greatly improve many of the negative effects and poor health outcomes associated with end-stage kidney disease. Exercise has yet to be incorporated effectively and systematically into routine care. Exercise programs remain rare. When such programs are implemented, their participation rates vary, and they neglect home and community-based activities, as well as the involvement of family caregivers to support and reinforce exercise. This study is intended to address these limitations by introducing a highly accessible and compelling educational film, Fit for Dialysis, designed to introduce, motivate, and sustain exercise for wellness amongst older hemodialysis patients, and exercise counseling and support by family caregivers, nephrologists, and nurses. The objective of this clinical trial is to determine whether and in what ways Fit for Dialysis improves outcomes and influences knowledge/attitudes regarding the importance of exercise-based principles of wellness in the context of end-stage renal disease. Ultimately Fit for Dialysis could be used as a model for dialysis education that supports guideline recommendations that exercise be incorporated into the care and treatment of dialysis patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2014
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 21, 2016
CompletedFirst Posted
Study publicly available on registry
April 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedApril 28, 2016
April 1, 2016
2.4 years
April 21, 2016
April 25, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Adherence measured by the percentage of time participants achieved at least 70% of prescribed targets of minutes and intensity of exercise per week.
1-16 weeks
Change in functional exercise capacity measured by the 2-Minute Walk Test
0, 8, 16, 28 weeks
Secondary Outcomes (5)
Change in number of steps using a pedometer
0, 8, 16, 28 weeks
Change in basic mobility using the Timed Up and Go
0, 8, 16, 28 weeks
Change in self-assessment of functional of capacities and peak metabolic equivalents using the Duke Activity Status Index
0, 8, 16, 28 weeks
Change in upper extremity strength as a predictor of mortality and deteriorating health using the Grip Strength Test
0, 8, 16, 28 weeks
Change in the frequency of mild, moderate, and strenuous bouts of exercise using the Godin Leisure-Time Exercise Questionnaire
1-16, 28 weeks
Study Arms (2)
Intervention
EXPERIMENTALA research-based film (Fit for Dialysis) and a 16-week exercise program involving activities during dialysis, at home, and in the community.
Control
NO INTERVENTIONThe 16-week exercise program involving activities during dialysis, at home, and in the community.
Interventions
A 15-minute research-based film that explores the barriers and facilitators regarding exercise participation by older hemodialysis patients and support by nephrology staff and family caregivers, and a 16-week exercise program involving activities during dialysis, at home, and in the community.
Eligibility Criteria
You may qualify if:
- Have conversational ability in English
- Have a medical diagnosis of hemodialysis-dependent end-stage renal disease
- Are a registered hemodialysis patient in the hospital for at least 3 months
- Receive ≥ 2 in-centre hemodialysis sessions per week
- Are ambulatory (with or without aids)
- Are deemed medically eligible by their nephrologist to participate in an exercise program that includes stretching, strengthening, and cardiovascular components
- Have a family caregiver who agrees to participate in the exercise program and keep a log of exercises on non-dialysis days
You may not qualify if:
- Currently participating in regular physical activity (structured exercise that includes a cardiovascular and/or strengthening component ≥ 3 times/week for ≥ 10 min/session
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Humber River Hospital - Wilson Site
Toronto, Ontario, M3M 0B2, Canada
St. Joseph's Health Centre - Satellite Site
Toronto, Ontario, M8Z 6A4, Canada
Related Publications (2)
Kontos P, Grigorovich A, Colobong R, Miller KL, Nesrallah GE, Binns MA, Alibhai SMH, Parsons T, Jassal SV, Thomas A, Naglie G. Fit for Dialysis: a qualitative exploration of the impact of a research-based film for the promotion of exercise in hemodialysis. BMC Nephrol. 2018 Aug 6;19(1):195. doi: 10.1186/s12882-018-0984-4.
PMID: 30081845DERIVEDKontos P, Alibhai SM, Miller KL, Brooks D, Colobong R, Parsons T, Jassal SV, Thomas A, Binns M, Naglie G. A prospective 2-site parallel intervention trial of a research-based film to increase exercise amongst older hemodialysis patients. BMC Nephrol. 2017 Jan 26;18(1):37. doi: 10.1186/s12882-017-0454-4.
PMID: 28122510DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pia Kontos, PhD
University Health Network, Toronto
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Scientist
Study Record Dates
First Submitted
April 21, 2016
First Posted
April 28, 2016
Study Start
April 1, 2014
Primary Completion
September 1, 2016
Study Completion
March 1, 2017
Last Updated
April 28, 2016
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will not share