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

Sponsor
Satellite Healthcare (Other)
Overall Status
Completed
CT.gov ID
NCT03944824
Collaborator
(none)
46
Enrollment
1
Location
2
Arms
4.8
Actual Duration (Months)
9.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Exercise Plan using resistance bands
  • Diagnostic Test: Modified Fried Frailty Scale
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 22, 2019
Actual Primary Completion Date :
Jul 10, 2019
Actual Study Completion Date :
Jul 17, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Other: Exercise Plan using resistance bands
Exercise under the guidance of an exercise physiologist using elastic resistance bands and weekly meeting with an exercise physiologist for 12 weeks

Diagnostic Test: Modified Fried Frailty Scale
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.
Placebo Comparator: 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.

Diagnostic Test: Modified Fried Frailty Scale
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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. Change in Sit-To-Stand Test [12 weeks]

    Change in physical function as measured by the 30 second sit to stand test (STS)

  2. Change in Handgrip Strength Test [12 weeks]

    Change in handgrip strength following the 12 week intervention as measured by a handgrip dynanometer

  3. Change in Timed Up and Go Test [12 weeks]

    Change in 8 foot timed up and go test (TUG).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Satellite Milpitas Milpitas California United States 95035

Sponsors and Collaborators

  • Satellite Healthcare

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Satellite Healthcare
ClinicalTrials.gov Identifier:
NCT03944824
Other Study ID Numbers:
  • SH066IDEX
First Posted:
May 10, 2019
Last Update Posted:
Sep 23, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Satellite Healthcare
Intra-Dialytic Exercise
End Stage Renal Disease
Hemodialysis
Therabands
Exercise Physiologist
Additional relevant MeSH terms:
Kidney Failure, Chronic

Study Results

No Results Posted as of Sep 23, 2019