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Clinical Trials/NCT03787589
NCT03787589RecruitingNot Applicable

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

Ottawa Hospital Research Institute1 site in 1 country90 target enrollmentStarted: April 15, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
90
Locations
1
Primary Endpoint
Adherence

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •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]
  • •Baseline step count greater than 8000 steps a day
  • •Planned living donor kidney transplant
  • •Potential for recovery of renal function
  • •Patients who feel unsafe using Nordic walking poles in place of their mobility aid
  • •Participation in another interventional trial that may affect the results of this study

Arms & Interventions

Exercise Intervention

Experimental

Participants in this arm will receive standard of care along with the exercise prescription intervention

Intervention: Exercise Prescription (Behavioral)

Standard of Care

No Intervention

This group will receive standard of care treatment including regular verbal encouragement to exercise (monthly) by dialysis unit staff.

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Sleep Quality(12 months)
  • Hospital Length of Stay(12 months)
  • Safety of the Exercise Program(12 months)
  • Change in Living Status(12 months)
  • Hand Grip Strength(12 months)
  • Quality of Life using Vitality Subscale(12 months)
  • Hospitalizations(12 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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