Clinical trial NCT03787589: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Renal Failure
Keywords: Renal Failure
Hemodialysis
Peritoneal Dialysis
Exercise
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2018-12-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Recruitment Feasibility
timeFrame: 30 months
measure: Adherence
timeFrame: 12 months
Secondary outcomes:
measure: Hand Grip Strength
timeFrame: 12 months
measure: Quality of Life using Vitality Subscale
timeFrame: 12 months
measure: Sleep Quality
timeFrame: 12 months
measure: Hospitalizations
timeFrame: 12 months
measure: Hospital Length of Stay
timeFrame: 12 months
measure: Change in Living Status
timeFrame: 12 months
measure: Safety of the Exercise Program
timeFrame: 12 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Deborah Zimmerman, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: