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

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.

Official Title
-----------------
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

Conditions
-----------------
End Stage Renal Failure on Dialysis, Frail Elderly Syndrome

Intervention / Treatment
-----------------
* Other: Exercise Plan using resistance bands
* Diagnostic Test: Modified Fried Frailty Scale


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The investigators will recruit 25 patients who will receive the exercise plans and once weekly visits from the exercise physiologists. 25 patients will be control. All 50 patients will receive pre and post physical function testing.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise (Intervention) Arm<br>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. | Other: Exercise Plan using resistance bands<br>* Exercise under the guidance of an exercise physiologist using elastic resistance bands and weekly meeting with an exercise physiologist for 12 weeks<br>Diagnostic Test: Modified Fried Frailty Scale<br>* Patients will be screened for frailty pre and post with sit-to-stand test, timed up and go test, handgrip strength test and administered the low physical activity questionnaire. These components together consist of the Modified Fried Frailty Index.<br>|
| Placebo Comparator: Control<br>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. | Diagnostic Test: Modified Fried Frailty Scale<br>* Patients will be screened for frailty pre and post with sit-to-stand test, timed up and go test, handgrip strength test and administered the low physical activity questionnaire. These components together consist of the Modified Fried Frailty Index.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Patient Adherence to Exercise Regimen | 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. | 12 weeks | 
| Rate of Adverse Events Secondary to Exercises | 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. | 12 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intra-Dialytic Exercise, End Stage Renal Disease, Hemodialysis, Therabands, Exercise Physiologist