Recruiting
Phase 2

Fit for Dialysis

Sponsor:

Toronto Rehabilitation Institute

Code:

NCT02754271

Conditions

End-Stage Renal Disease

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Fit for Dialysis

Study Details

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.

Conditions

End-Stage Renal Disease

Study ID

NCT02754271

Start date

Apr, 2014

Status verified date

Apr, 2016

Completion date

Mar, 2017

Anticipated

Primary completion date

Sep, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Currently participating in regular physical activity (structured exercise that includes a cardiovascular and/or strengthening component ≥ 3 times/week for ≥ 10 min/session

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Intervention

A research-based film (Fit for Dialysis) and a 16-week exercise program involving activities during dialysis, at home, and in the community.

no intervention: Control

The 16-week exercise program involving activities during dialysis, at home, and in the community.

Interventions

Fit for Dialysis

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.

Primary outcome measure

  • Adherence measured by the percentage of time participants achieved at least 70% of prescribed targets of minutes and intensity of exercise per week. [ Time Frame: 1-16 weeks ]
  • Change in functional exercise capacity measured by the 2-Minute Walk Test [ Time Frame: 0, 8, 16, 28 weeks ]

Central Contacts and Locations

Central contacts

Pia Kontos, PhD

416-597-3422pia.kontos@uhn.ca

Romeo Colobong, MA

416-597-3422romeo.colobong@uhn.ca

Locations

Humber River Hospital - Wilson Site

Recruiting

Toronto, Ontario, Canada, M3M 0B2

More Information

Sponsor

Toronto Rehabilitation Institute

Last update posted

Apr 28, 2016

Last verified

Apr, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Toronto Rehabilitation Institute on 2016-04-28.