Exercise in Patients With End Stage Kidney Disease

Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03787589
• Other study ID #: 618
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: September 15, 2024

Study information

• Verified date: November 2023
• Source: Ottawa Hospital Research Institute
• Contact: Deborah Zimmerman, MD, MSc
• Phone: 613-738-8400
• Email: dzimmerman[@]toh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 15, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases
• Kidney Failure, Chronic
• Renal Failure
• Renal Insufficiency

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.

Locations

Country	Name	City	State
Canada	Ottawa Hospital	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Feasibility	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.	30 months
Primary	Adherence	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.	12 months
Secondary	Hand Grip Strength	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)	12 months
Secondary	Quality of Life using Vitality Subscale	Energy will be measured with the Medical Outcomes Study 36 Item Short Form Survey Instrument - Vitality Subscale (Score 0 (lowest) -100 (highest, more energy)	12 months
Secondary	Sleep Quality	Sleep will be measured with the Pittsburgh Sleep Quality Index (Score 0-21; lower scores reflect better sleep).	12 months
Secondary	Hospitalizations	The number of hospitalizations per patient year	12 months
Secondary	Hospital Length of Stay	Average number of days spent in hospital	12 months
Secondary	Change in Living Status	Including full care (admission to a long-term care facility), need for assistance such as housekeeping, meals, bathing	12 months
Secondary	Safety of the Exercise Program	Safety will be measured by monitoring serious adverse events	12 months