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

Satellite Healthcare

Status: Completed

Conditions: End Stage Renal Failure on Dialysis; Frail Elderly Syndrome

Treatments: Other: Exercise Plan using resistance bands; Diagnostic Test: Modified Fried Frailty Scale

Study type: Interventional

Funder types: Other

Identifiers

NCT03944824

SH066IDEX

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups, including a placebo group

Exercise (Intervention) Arm

Experimental group

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.

Treatment:

Diagnostic Test: Modified Fried Frailty Scale

Other: Exercise Plan using resistance bands

Control

Placebo Comparator group

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.

Treatment:

Diagnostic Test: Modified Fried Frailty Scale