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NCT Number: NCT03944824

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

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.

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Key information

Conditions

End Stage Renal Failure on Dialysis Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Frail Elderly Syndrome Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Satellite Milpitas

Milpitas, California, 95035, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Plan using resistance bands

Other

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

Modified Fried Frailty Scale

Diagnostic Test

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 outcomes

  1. Rate of Patient Adherence to Exercise Regimen

    Time frame: 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

    Time frame: 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 outcomes

  1. Change in Sit-To-Stand Test

    Time frame: 12 weeks

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

  2. Change in Handgrip Strength Test

    Time frame: 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

    Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

Satellite Healthcare

Other

Registry information

Official study 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

Acronym: IDEX

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 10, 2019
Registry last updated
Sep 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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