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

Primary Purpose

End Stage Renal Failure on Dialysis, Frail Elderly Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Plan using resistance bands
Modified Fried Frailty Scale
Sponsored by
Satellite Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Failure on Dialysis focused on measuring Intra-Dialytic Exercise, End Stage Renal Disease, Hemodialysis, Therabands, Exercise Physiologist

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Satellite Milpitas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Exercise (Intervention) Arm

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
February 12, 2019
Last Updated
September 19, 2019
Sponsor
Satellite Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT03944824
Brief Title
The Effect of Intradialytic Exercise on the Physical Function of People Undergoing Hemodialysis
Acronym
IDEX
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
February 22, 2019 (Actual)
Primary Completion Date
July 10, 2019 (Actual)
Study Completion Date
July 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Satellite Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Failure on Dialysis, Frail Elderly Syndrome
Keywords
Intra-Dialytic Exercise, End Stage Renal Disease, Hemodialysis, Therabands, Exercise Physiologist

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking Description
No masking, patients and physicians will be aware of their study arm assignment
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise (Intervention) Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Exercise Plan using resistance bands
Intervention Description
Exercise under the guidance of an exercise physiologist using elastic resistance bands and weekly meeting with an exercise physiologist for 12 weeks
Intervention Type
Diagnostic Test
Intervention Name(s)
Modified Fried Frailty Scale
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of Patient Adherence to Exercise Regimen
Description
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.
Time Frame
12 weeks
Title
Rate of Adverse Events Secondary to Exercises
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in Sit-To-Stand Test
Description
Change in physical function as measured by the 30 second sit to stand test (STS)
Time Frame
12 weeks
Title
Change in Handgrip Strength Test
Description
Change in handgrip strength following the 12 week intervention as measured by a handgrip dynanometer
Time Frame
12 weeks
Title
Change in Timed Up and Go Test
Description
Change in 8 foot timed up and go test (TUG).
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Satellite Milpitas
City
Milpitas
State/Province
California
ZIP/Postal Code
95035
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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11253156
Citation
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The Effect of Intradialytic Exercise on the Physical Function of People Undergoing Hemodialysis

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