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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Satellite Healthcare
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Rate of Patient Adherence to Exercise Regimen
Study 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:
- Test the feasibility of a 3-month exercise physiologist led program
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
No masking, patients and physicians will be aware of their study arm assignment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Exercise (Intervention) Arm
The 25 patients in this arm will receive an interventional exercise plan using resistance bands and once weekly visits from an exercise physiologist while on dialysis for 12 weeks. They will undergo a frailty screening using a Modified Fried Frailty Scale at the beginning and end of the trial to include: Timed up and Go test, Sit-to-Stand Test, Handgrip Strength Test, Low physical activity questionnaire.
Intervention: Exercise Plan using resistance bands (Other)
Exercise (Intervention) Arm
The 25 patients in this arm will receive an interventional exercise plan using resistance bands and once weekly visits from an exercise physiologist while on dialysis for 12 weeks. They will undergo a frailty screening using a Modified Fried Frailty Scale at the beginning and end of the trial to include: Timed up and Go test, Sit-to-Stand Test, Handgrip Strength Test, Low physical activity questionnaire.
Intervention: Modified Fried Frailty Scale (Diagnostic Test)
Control
The 25 patients in the control arm will not receive an interventional exercise plan or visits from an exercise physiologist while on dialysis for 12 weeks. They will undergo a frailty screening using a Modified Fried Frailty Scale at the beginning and end of the trial to include: Timed up and Go test, Sit-to-Stand Test, Handgrip Strength Test, Low physical activity questionnaire.
Intervention: Modified Fried Frailty Scale (Diagnostic Test)
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)