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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03944824
Acronym
IDEX
Enrollment
46
Registered
2019-05-10
Start date
2019-02-22
Completion date
2019-07-17
Last updated
2019-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Failure on Dialysis, Frail Elderly Syndrome

Keywords

Intra-Dialytic Exercise, End Stage Renal Disease, Hemodialysis, Therabands, Exercise Physiologist

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.

Interventions

OTHERExercise 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_TESTModified 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.

Sponsors

Satellite Healthcare
Lead SponsorOTHER

Study design

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

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Rate of Patient Adherence to Exercise Regimen12 weeksAdherence 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 Exercises12 weeksAdverse 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

MeasureTime frameDescription
Change in Sit-To-Stand Test12 weeksChange in physical function as measured by the 30 second sit to stand test (STS)
Change in Handgrip Strength Test12 weeksChange in handgrip strength following the 12 week intervention as measured by a handgrip dynanometer
Change in Timed Up and Go Test12 weeksChange in 8 foot timed up and go test (TUG).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026