Effect of an Exercise Rehabilitation Program on Symptoms in Hemodialysis

• ClinicalTrials.gov Identifier: NCT02259413
• Recruitment Status: Active, not recruiting
• First Posted: October 8, 2014
• Last Update Posted: November 1, 2022
• Sponsor: University of Manitoba
• Collaborator: The Wellness Institute at Seven Oaks General Hospital
• Information provided by (Responsible Party): University of Manitoba

Study Description

Brief Summary:

The purpose of this study is to determine whether participation in a 26-week exercise rehabilitation program is effective at reducing symptom burden and improving quality of life in individuals receiving chronic hemodialysis.

Condition or disease	Intervention/treatment	Phase
End-stage Renal Disease; Renal Failure Chronic Requiring Hemodialysis	Behavioral: Exercise Rehabilitation	Not Applicable

Detailed Description:

Individuals with end-stage kidney disease requiring HD suffer from multiple symptoms, which have limited effective treatments. Symptom burden, the combined impact of number and severity of symptoms, negatively impacts functional status and health-related quality of life (HRQOL) in HD. Small interventional trials suggest exercise can mitigate specific individual symptoms, but impact of exercise on overall symptom burden in HD is unknown. Dialysis patients have identified improving symptom burden and HRQOL as research priorities. We propose the first randomized controlled trial (RCT) investigating the effect of exercise rehabilitation on symptom burden in individuals on HD.

Hypothesis: In individuals on HD, participation in a 26-week exercise rehabilitation (rehab) program will reduce symptom burden and improve HRQOL, resulting in reduced disability and improved long-term clinical outcomes as compared with standard care.

Study Design: Single-centre RCT with one-to-one parallel design, allocation concealment and assessor blinding

Study Population: Adults receiving chronic in-centre HD for > 3 months with at least one dialysis-related symptom; n=150

Intervention: Standard care plus 26-week structured rehab program (lifestyle education, resistance exercise and cycling during HD).

Control: Standard care (baseline exercise counseling)

Outcomes measured at baseline, 12, 26 and 52 weeks.

Data Analysis: Will be performed on an intention to treat, available case basis with t-tests or Mann Whitney U for continuous outcomes, as per data distribution and Chi square tests for categorical outcomes. Mixed effects modeling will account for repeated outcome measures over time. Poisson regression will be performed for hospitalization analysis.

Anticipated Outcomes: Mean symptom burden severity score will decrease by 20% from baseline in the intervention group at 12 weeks. Due to sustained physical activity in the intervention group, symptom burden will remain lower in this group at 6 months. In contrast, the control group will see no improvement in symptom burden from baseline.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 172 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of an Exercise Rehabilitation Program on Symptom Burden and Quality of Life in Hemodialysis: A Randomized Controlled Study
• Actual Study Start Date: May 2015
• Estimated Primary Completion Date: February 28, 2023
• Estimated Study Completion Date: May 31, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Exercise Rehabilitation; Participants will receive baseline exercise counselling as per Standard Care group. Participants will then participate in a 26-week exercise rehabilitation program incorporating 3 components: One-to-one self-management/resistance education once per week during the first 4 weeks of intervention. Participants will subsequently receive resistance training material to allow for home exercise for the remaining 22 weeks of the intervention.; Intradialytic aerobic exercise on a cycle ergometer 3 times weekly for 26 weeks at their usual hemodialysis sessions.; Four additional one-to-one standardized education sessions will be completed during the intervention period.	Behavioral: Exercise Rehabilitation; This intervention will consist of lifestyle education, home-based resistance exercise and stationary cycling during hemodialysis sessions. Duration of the intervention will be 26 weeks
No Intervention: Standard Care; Participants will receive one exercise counseling session as part of their baseline assessment. Participants in the control group will not undergo any other exercise counseling or formal exercise intervention, but will not be prohibited from participating in exercise outside of the study protocol.

Outcome Measures

Primary Outcome Measures :

1. Change in dialysis symptom burden at 12 weeks [ Time Frame: Measured at study baseline and 12 weeks after study start ]
   Measured using change in the Dialysis Symptom Index

Secondary Outcome Measures :

1. Change in dialysis symptom burden at 26 and 52 weeks [ Time Frame: Measured at study baseline, 26 and 52 weeks after study start ]
   Measured using change in the Dialysis Symptom Index
2. Change in modified symptom burden [ Time Frame: Measured at study baseline, 12, 26 and 52 weeks after study start ]
   Measured using change in modified Dialysis Symptom Index
3. Change in health-related quality of life [ Time Frame: Measured at study baseline, 12, 26 and 52 weeks after study start ]
   Measured by self-report using the EuroQol 5D-5L (EQ5D-5L) and EuroQol Visual Analogue Scale.
4. Change in time for recovery post-dialysis [ Time Frame: Measured at study baseline, 12, 26 and 52 weeks after study start ]
   Measured in minutes with the question "Approximately how much time does it take to recover from a dialysis session"
5. Change in endurance/exercise capacity [ Time Frame: Measured at study baseline, 12, 26 and 52 weeks after study start ]
   Measured using the Incremental Shuttle Walk Test
6. Change in frailty status [ Time Frame: Measured at study baseline, 12, 26 and 52 weeks after study start ]
   Measured using the Modified Fried Criteria for frailty.
7. Change in self-efficacy for exercise [ Time Frame: Measured at study baseline, 12, 26 and 52 weeks after study start ]
   Measured using the Self-Efficacy for Exercise Survey a 9 item self-reported assessment tool

Other Outcome Measures:

1. Change in physical activity behaviour pattern [ Time Frame: Measured at study baseline, 12, 26 and 52 weeks after study start ]

   Measured in 2 ways:

   1. Subjectively using the self-reported Godin-Shephard Leisure Time Physical Activity Questionnaire
   2. Objectively using multi-directional accelerometers (Actical Physical Activity Monitors TM) which will be worn for 7 days at each measurement time point

   2.

2. Hospitalization rate [ Time Frame: Measured at study baseline, 12, 26 and 52 weeks after study start ]
   Measured by number of hospitalizations and length of stay for each hospitalization
3. Mortality [ Time Frame: Measured at 1 year after starting dialysis ]
   Measured as the proportion of people who died during the first year on dialysis

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• greater than 3 months after starting chronic hemodialysis
• no planned change in hemodialysis modality or relocation outside of Winnipeg during study intervention period (26 weeks)
• assessed to be safe and able to exercise by HD unit nephrologist
• ability to communicate in English and provide informed written consent

Exclusion Criteria:

• acute coronary syndrome in past 3 months
• unstable arrhythmia
• shortness of breath at rest or with minimal activity (NYHA Class 4)
• symptomatic hypoglycaemia (> 2x/week in week prior to enrolment)
• currently participating in the Manitoba Renal Program clinical intradialytic cycling program
• score of 0 on Dialysis Symptom Index when administered at time of consent

Contacts and Locations

Locations

Canada, Manitoba

Health Sciences Centre

Winnipeg, Manitoba, Canada, R3A1R9

Seven Oaks General Hospital

Winnipeg, Manitoba, Canada

St. Boniface Hospital

Winnipeg, Manitoba, Canada

Sponsors and Collaborators

University of Manitoba

The Wellness Institute at Seven Oaks General Hospital

Investigators

• Principal Investigator: Clara J Bohm, MD, MPH; University of Manitoba

  Study Documents (Full-Text)

Documents provided by University of Manitoba:

Study Protocol and Statistical Analysis Plan  [PDF] June 22, 2020

Informed Consent Form  [PDF] September 5, 2019

More Information

• Responsible Party: University of Manitoba
• ClinicalTrials.gov Identifier: NCT02259413
• Other Study ID Numbers: B2014:088
• First Posted: October 8, 2014
• Last Update Posted: November 1, 2022
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by University of Manitoba:

Hemodialysis; End-stage renal disease; Exercise; Symptom Burden

Additional relevant MeSH terms:

Kidney Diseases; Kidney Failure, Chronic; Urologic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency