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Clinical Trials/NCT03944824
NCT03944824
Completed
Not Applicable

The Effect of Intradialytic Resistance Exercises Using Resistance Bands With Exercise Physiologist Consultation on the Physical Function of People Undergoing Hemodialysis: a Proof of Concept Study

Satellite Healthcare1 site in 1 country46 target enrollmentFebruary 22, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
End Stage Renal Failure on Dialysis
Sponsor
Satellite Healthcare
Enrollment
46
Locations
1
Primary Endpoint
Rate of Patient Adherence to Exercise Regimen
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The investigators intend to recruit 50 patients into an intradialytic exercise study that will measure the impact of resistance bands exercises under the guidance of an exercise physiologist on the physical function of hemodialysis patients.

Detailed Description

The primary objective of this study will be to test the feasibility and efficacy of a 3 month exercise physiologist consultation program. Specifically, the investigator's aims will be to: 1. Test the feasibility of a 3-month exercise physiologist led program 2. Measure the effect of an exercise physiologist collaboration and intradialytic exercise on the physical function of HD patients using the 30 second STS test, handgrip strength test \[required for frailty scale\], 8-foot TUG test and patient physical activity based off of the Low Physical Activity Questionnaire.

Registry
clinicaltrials.gov
Start Date
February 22, 2019
End Date
July 17, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age 18 years or greater
  • Ability to understand and communicate English
  • Diagnosis of ESRD and currently undergoing in-center hemodialysis
  • On HD for longer than 6 weeks
  • Approved by the Satellite Milpitas Medical Director and/or referring physician

Exclusion Criteria

  • Previous major amputations
  • Inability to independently ambulate
  • Known to be pregnant

Outcomes

Primary Outcomes

Rate of Patient Adherence to Exercise Regimen

Time Frame: 12 weeks

Adherence calculated as the total number of self-reported exercise sessions attempted by the patient when EP not present divided by the total number of hemodialysis sessions.

Rate of Adverse Events Secondary to Exercises

Time Frame: 12 weeks

Adverse events defined as any injury, impairment or medical condition that was directly or suspected to be due to performing the prescribed exercise. This information will be collected from the patient at the weekly meeting with the EPs.

Secondary Outcomes

  • Change in Timed Up and Go Test(12 weeks)
  • Change in Sit-To-Stand Test(12 weeks)
  • Change in Handgrip Strength Test(12 weeks)

Study Sites (1)

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