The Effect of Intradialytic Exercise on the Physical Function of People Undergoing Hemodialysis

Not Applicable

Completed

• Conditions: End Stage Renal Failure on Dialysis; Frail Elderly Syndrome
• Interventions: Other: Exercise Plan using resistance bands; Diagnostic Test: Modified Fried Frailty Scale

• Registration Number: NCT03944824
• Lead Sponsor: Satellite Healthcare

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.

Study Timeline

• Study First Submitted: 2019-02-12
• Study Start: 2019-02-22
• Study First Submitted QC: 2019-05-07
• Study First Posted: 2019-05-10
• Primary Completion: 2019-07-10
• Study Completion: 2019-07-17
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-19
• Last Update Posted: 2019-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise (Intervention) Arm	Exercise Plan using resistance bands	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.
Exercise (Intervention) Arm	Modified Fried Frailty Scale	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.
Control	Modified Fried Frailty Scale	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.

Primary Outcome Measures

Name	Time	Method
Rate of Patient Adherence to Exercise Regimen	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	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 Outcome Measures

Name	Time	Method
Change in Timed Up and Go Test	12 weeks	Change in 8 foot timed up and go test (TUG).
Change in Sit-To-Stand Test	12 weeks	Change in physical function as measured by the 30 second sit to stand test (STS)
Change in Handgrip Strength Test	12 weeks	Change in handgrip strength following the 12 week intervention as measured by a handgrip dynanometer

Trial Locations

Locations (1)

Satellite Milpitas; 🇺🇸 Milpitas, California, United States