Exercise in Patients With End Stage Kidney Disease

• ClinicalTrials.gov Identifier: NCT03787589
• Recruitment Status: Recruiting
• First Posted: December 26, 2018
• Last Update Posted: October 3, 2022
• Sponsor: Ottawa Hospital Research Institute
• Collaborator: Canadian Institutes of Health Research (CIHR)
• Information provided by (Responsible Party): Ottawa Hospital Research Institute

Tracking Information

• First Submitted Date: October 1, 2018
• First Posted Date: December 26, 2018
• Last Update Posted Date: October 3, 2022
• Actual Study Start Date: April 15, 2019
• Estimated Primary Completion Date: September 15, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 19, 2019)

• Recruitment Feasibility [ Time Frame: 30 months ]
  The investigators will assess at each centre the number of participants receiving dialysis, approached for participation, eligible to participate and any reasons for non-participation.
• Adherence [ Time Frame: 12 months ]
  Two-week step counts with a pedometer will be monitored monthly in the treatment group, and at baseline, 6 and 12 months in the control group.

Original Primary Outcome Measures (submitted: December 21, 2018)

• Recruitment Feasibility [ Time Frame: 30 months ]
  We will assess at each centre the number of participants receiving dialysis, approached for participation, eligible to participate and any reasons for non-participation.
• Adherence (average step count determined from the maximum number of steps per day on 6 days over the two week period) [ Time Frame: 12 months ]
  Two-week step counts with a pedometer will be monitored monthly in the treatment group, and at baseline, 6 and 12 months in the control group.

Current Secondary Outcome Measures (submitted: September 14, 2020)

• Hand Grip Strength [ Time Frame: 12 months ]
  The investigators will measure hand grip strength at baseline, 6, and 12 months using a handgrip dynamometer in the dominant hand or in the non-arteriovenous fistula arm (best of two efforts in kgs)
• Quality of Life using Vitality Subscale [ Time Frame: 12 months ]
  Energy will be measured with the Medical Outcomes Study 36 Item Short Form Survey Instrument - Vitality Subscale (Score 0 (lowest) -100 (highest, more energy)
• Sleep Quality [ Time Frame: 12 months ]
  Sleep will be measured with the Pittsburgh Sleep Quality Index (Score 0-21; lower scores reflect better sleep).
• Hospitalizations [ Time Frame: 12 months ]
  The number of hospitalizations per patient year
• Hospital Length of Stay [ Time Frame: 12 months ]
  Average number of days spent in hospital
• Change in Living Status [ Time Frame: 12 months ]
  Including full care (admission to a long-term care facility), need for assistance such as housekeeping, meals, bathing
• Safety of the Exercise Program [ Time Frame: 12 months ]
  Safety will be measured by monitoring serious adverse events

Original Secondary Outcome Measures (submitted: December 21, 2018)

• Hand Grip Strength as assessed with a handgrip dynamometer (kgs) [ Time Frame: 12 months ]
  We will measure hand grip strength at baseline, 6, and 12 months using a handgrip dynamometer in the dominant hand or in the non-arteriovenous fistula arm (best of two efforts in kgs)
• Medical Outcomes Study 36 Item Short Form Survey - Vitality Subscale [ Time Frame: 12 months ]
  Energy will be measured with the Medical Outcomes Study 36 Item Short Form Survey Instrument - Vitality Subscale (Score 0 (lowest) -100 (highest, more energy)
• Sleep Quality will be assessed with the Pittsburgh Sleep Quality Index [ Time Frame: 12 months ]
  Sleep will be measured with the Pittsburgh Sleep Quality Index (Score 0-21; lower scores reflect better sleep).
• Hospitalizations (per patient year) [ Time Frame: 12 months ]
  The number of hospitalizations per patient year
• Hospital Length of Stay [ Time Frame: 12 months ]
  Average number of days spent in hospital
• Change in living status as assessed by the need for increased assistance with activities of daily living [ Time Frame: 12 months ]
  Including full care (admission to a long-term care facility), need for assistance such as housekeeping, meals, bathing
• Safety of the Exercise Program as determined by the number of serious adverse events [ Time Frame: 12 months ]
  Safety will be measured by monitoring serious adverse events

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Exercise in Patients With End Stage Kidney Disease
• Official Title: A Simple Exercise Program for Patients With End Stage Kidney Disease to Improve Strength and Quality of Life: A Feasibility Study

Brief Summary

This study will be conducted over a 3 year time period. This is a trial of an exercise intervention vs. standard of care in patients receiving chronic dialysis. The specific aims will be to determine feasibility of patient recruitment, adherence to the exercise program, and efficacy of the intervention on patient important outcomes.

The exercise intervention will be delivered to randomized participants for 12 months, and consist of the prescribed use of Nordic Walking poles, online resources for exercise in the home, regular use of a pedometer to monitor progress, and regular verbal encouragement to exercise (monthly) by dialysis unit staff. Both groups will receive the same standard of care co-interventions including individualized dialysis prescriptions and health-care interactions according to practices at their centre.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Renal Failure

Intervention

Behavioral: Exercise Prescription

Participants in the intervention group will be given an exercise prescription to increase their baseline steps by 1200 and 2000 steps per day at least 3 days a week over the first 3 months. If tolerated and accepted, the participants will increase their step counts by an additional 600 to 1000 steps per day at least 3 days a week for the next 3 months.This will be followed by a 6-month maintenance phase. The research coordinator will instruct the participants on the proper use of the Nordic walking poles which can be used to help participants achieve their prescribed number of steps.

All participants will be encouraged to wear the pedometer throughout the trial in order to follow the step-count prescription and monitor adherence.

Study Arms

• Experimental: Exercise Intervention
  Participants in this arm will receive standard of care along with the exercise prescription intervention
  Intervention: Behavioral: Exercise Prescription
• No Intervention: Standard of Care
  This group will receive standard of care treatment including regular verbal encouragement to exercise (monthly) by dialysis unit staff.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 21, 2018): 90
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 15, 2024
• Estimated Primary Completion Date: September 15, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. All ambulatory adult patients with end stage kidney disease
2. Treatment with peritoneal dialysis or hemodialysis for greater than six months
3. Able to understand English or French
4. Abuse to use Nordic Walking poles
5. Able and willing to provide informed consent

Exclusion Criteria:

1. Any absolute contraindication to exercise [unstable angina, uncontrolled hypertension (systolic or diastolic blood pressure greater than 180 mmHg (millimeters of mercury) or greater than 110 mmHg, respectively), deemed not suitable for exercise by the treating physician]
2. Baseline step count greater than 8000 steps a day
3. Planned living donor kidney transplant
4. Potential for recovery of renal function
5. Patients who feel unsafe using Nordic walking poles in place of their mobility aid
6. Participation in another interventional trial that may affect the results of this study

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Deborah Zimmerman, MD, MSc; 613-738-8400 ext 82534; dzimmerman@toh.ca

• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT03787589
• Other Study ID Numbers: 618
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: The study protocol, manual of operations and consent form will be made available by contacting the corresponding author. De-identified patient data will be available from 12 months to 3 years after manuscript publication to researchers with methodologically sound proposals approved by the principal investigator.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: Analytic Code
• Time Frame: One year after publication up to 3 years post publication
• Access Criteria: researchers with methodologically sound proposals approved by the principal investigator

• Current Responsible Party: Ottawa Hospital Research Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: Ottawa Hospital Research Institute
• Original Study Sponsor: Same as current
• Collaborators: Canadian Institutes of Health Research (CIHR)

Investigators

• Principal Investigator: Deborah Zimmerman, MD, MSc; Ottawa Hospital Research Institute

• PRS Account: Ottawa Hospital Research Institute
• Verification Date: September 2022