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Trial record 52 of 2235 for:    Recruiting, Not yet recruiting, Available Studies | Renal

Exercise in Patients With End Stage Kidney Disease

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ClinicalTrials.gov Identifier: NCT03787589
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : July 23, 2019
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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, regular use of a pedometer to monitor progress, and for participants with Wi-Fi access, participation in a physical activity social network with other patients. Both groups will receive 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.


Condition or disease Intervention/treatment Phase
Renal Failure Behavioral: Exercise Prescription Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Simple Exercise Program for Patients With End Stage Kidney Disease to Improve Strength and Quality of Life: A Feasibility Study
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise Intervention
Participants in this arm will receive standard of care along with the exercise prescription 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, monitor adherence and allow them to join a virtual exercise group that will include dialysis patients with similar levels of baseline activity.


No Intervention: Standard of Care
This group will receive standard of care treatment including regular verbal encouragement to exercise (monthly) by dialysis unit staff.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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)

  2. Quality of Life [ 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)

  3. Sleep Quality [ Time Frame: 12 months ]
    Sleep will be measured with the Pittsburgh Sleep Quality Index (Score 0-21; lower scores reflect better sleep).

  4. Hospitalizations [ Time Frame: 12 months ]
    The number of hospitalizations per patient year

  5. Hospital Length of Stay [ Time Frame: 12 months ]
    Average number of days spent in hospital

  6. 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

  7. Safety of the Exercise Program [ Time Frame: 12 months ]
    Safety will be measured by monitoring serious adverse events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 180mmHg or greater than 110mmHg, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787589


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

Locations
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Canada, Ontario
Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 1A2
Principal Investigator: Deborah Zimmerman, MD, MSc         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Institutes of Health Research (CIHR)

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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03787589     History of Changes
Other Study ID Numbers: 618
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (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
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ottawa Hospital Research Institute:
Renal Failure
Hemodialysis
Peritoneal Dialysis
Exercise
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic