Effects of Intradialytic Exercise on Health-related Quality of Life

August 3, 2021 updated by: CHIA-HUEI LIN, PhD, Tri-Service General Hospital

Effects of Intradialytic Exercise on Dialytic Parameters, Health-related Quality of Life, and Depression Status in Hemodialysis Patients: A Randomized Controlled Trial

This study aimed to evaluate the effects of intradialyic exercise on dialytic parameters, HRQL, and depression status in hemodialysis patients. A randomized controlled trial was conducted. Sixty-four participants were recruited using stratified random sampling and allocated with a 1:1 randomization ratio to either experimental group (EG, treated in odd weekdays, n = 32) or comparison group (CG, treated in even weekdays, n = 32). The EG received a 12-week intradialytic exercise, while the CG maintained usual lifestyles. Dialytic parameters, HRQL, and depression status were collected at baseline and at 12 weeks. The results indicated that there were no differences in changes of dialytic parameters from baseline between EG and CG. However, the EG had increased HRQL and reduced depression status at 12 weeks compared with the CG. A 12-week intradialytic exercise is safe, feasible and effective in improved HRQL and reduced depression status for hemodialysis patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Exercise has been shown to be of fundamental importance in managing chronic diseases and improving health-related quality of life (HRQL) as well as psychological health. However, whether intradialyic exercise is safe and has positive impact on HRQL and depression status in hemodialysis patients requires further researches with diverse racial and cultural groups to clarify. This study aimed to evaluate the effects of intradialyic exercise on dialytic parameters, HRQL, and depression status in hemodialysis patients. A randomized controlled trial was conducted at a medical center in Northern Taiwan. Sixty-four participants from 112 eligible hemodialysis patients were recruited using stratified random sampling and allocated with a 1:1 randomization ratio to either experimental group (EG, treated in odd weekdays, n = 32) or comparison group (CG, treated in even weekdays, n = 32). The EG received a 12-week intradialytic exercise (supine lower-limb ergometer, 30 minutes/session, 3 sessions/week), while the CG maintained usual lifestyles. Dialytic parameters (serum chemistries, serum electrolytes, and estimated glomerular filtration rate), HRQL, and depression status were collected at baseline and at 12 weeks. The results indicated that there were no differences in changes of dialytic parameters from baseline between EG and CG. However, the EG had increased HRQL (ß = 22.6, p<.001) and reduced depression status (ß = -7.5, p = .02) at 12 weeks compared with the CG. A 12-week intradialytic exercise is safe, feasible and effective in improved HRQL and reduced depression status for hemodialysis patients.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Hawaii
      • Taipei, Hawaii, Taiwan, 11105
        • Chia-Huei Lin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • (1) ESRD patients on maintenance of hemodialysis; (2) aged 20 to 80 years; (3) able to speak and understand Mandarin; (4) had received regular treatment with hemodialysis (3 times/ week) for at least 6 months; (5) agreed to be randomized to one of the two groups.

Exclusion Criteria:

  • lower limb disabilities, hospitalized patients, treatment with peritoneal dialysis, received hemodialysis less than 3 times/ week, a history of recent acute myocardial infarction, unstable angina, uncontrolled arrhythmia, acute stroke, hospitalization experience within 6 months, cancer, and diagnosed with mental illness, especially depression.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
The experimental group received a 12-week intradialytic exercise (supine lower-limb ergometer, 30 minutes/session, 3 sessions/week)
Behavioral: a 12-week intradialytic exercise
a 12-week intradialytic exercise (supine lower-limb ergometer, 30 minutes/session, 3 sessions/week)
No Intervention: control group
the control group maintained their usual lifestyles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dialytic parameters: red blood cell [count/ul]
Time Frame: Change from baseline red blood cell [count/ul] assessed by blood analysis at 12 weeks
red blood cell [count/ul]
Change from baseline red blood cell [count/ul] assessed by blood analysis at 12 weeks
Dialytic parameters: hemoglobin [g/dl]
Time Frame: Change from baseline hemoglobin [g/dl] assessed by blood analysis at 12 weeks
hemoglobin [g/dl]
Change from baseline hemoglobin [g/dl] assessed by blood analysis at 12 weeks
Dialytic parameters: hematocrit [%]
Time Frame: Change from baseline hematocrit [%] assessed by blood analysis at 12 weeks
hematocrit [%]
Change from baseline hematocrit [%] assessed by blood analysis at 12 weeks
Dialytic parameters: mean corpuscular volume [fl]
Time Frame: Change from baseline mean corpuscular volume [fl] assessed by blood analysis at 12 weeks
mean corpuscular volume [fl]
Change from baseline mean corpuscular volume [fl] assessed by blood analysis at 12 weeks
Dialytic parameters: albumin [g/dl]
Time Frame: Change from baseline albumin [g/dl] assessed by blood analysis at 12 weeks
albumin [g/dl]
Change from baseline albumin [g/dl] assessed by blood analysis at 12 weeks
Dialytic parameters: GPT [IU/l]
Time Frame: Change from baseline [IU/l] assessed by blood analysis at 12 weeks
GPT [IU/l]
Change from baseline [IU/l] assessed by blood analysis at 12 weeks
Dialytic parameters: GOT [IU/l]
Time Frame: Change from baseline GOT [IU/l] assessed by blood analysis at 12 weeks
GOT [IU/l]
Change from baseline GOT [IU/l] assessed by blood analysis at 12 weeks
Dialytic parameters: blood urea nitrogen [BUN, mg/dl]
Time Frame: Change from baseline blood urea nitrogen [BUN, mg/dl] assessed by blood analysis at 12 weeks
blood urea nitrogen [BUN, mg/dl]
Change from baseline blood urea nitrogen [BUN, mg/dl] assessed by blood analysis at 12 weeks
Dialytic parameters: creatinine [Cr, mg/dl])
Time Frame: Change from baseline creatinine [Cr, mg/dl]) assessed by blood analysis at 12 weeks
creatinine [Cr, mg/dl])
Change from baseline creatinine [Cr, mg/dl]) assessed by blood analysis at 12 weeks
Dialytic parameters: sodium [Na, mEq/l]
Time Frame: Change from baseline sodium [Na, mEq/l] assessed by blood analysis at 12 weeks
sodium [Na, mEq/l]
Change from baseline sodium [Na, mEq/l] assessed by blood analysis at 12 weeks
Dialytic parameters: potassium [K, mEq/l]
Time Frame: Change from baseline potassium [K, mEq/l] assessed by blood analysis at 12 weeks
potassium [K, mEq/l]
Change from baseline potassium [K, mEq/l] assessed by blood analysis at 12 weeks
Dialytic parameters: calcium [Ca, mg/dl]
Time Frame: Change from baseline calcium [Ca, mg/dl] assessed by blood analysis at 12 weeks
calcium [Ca, mg/dl]
Change from baseline calcium [Ca, mg/dl] assessed by blood analysis at 12 weeks
Dialytic parameters: phosphate [P, mg/dl]
Time Frame: Change from baseline phosphate [P, mg/dl] assessed by blood analysis at 12 weeks
phosphate [P, mg/dl]
Change from baseline phosphate [P, mg/dl] assessed by blood analysis at 12 weeks
Dialytic parameters: IPTH [pg/ml]
Time Frame: Change from baseline IPTH [pg/ml] assessed by blood analysis at 12 weeks
IPTH [pg/ml]
Change from baseline IPTH [pg/ml] assessed by blood analysis at 12 weeks
Dialytic parameters: estimated GFR [ml/min1.73m2])
Time Frame: Change from baseline estimated GFR [ml/min1.73m2]) assessed by estimation based on serum creatinine at 12 weeks
estimated GFR [ml/min1.73m2])
Change from baseline estimated GFR [ml/min1.73m2]) assessed by estimation based on serum creatinine at 12 weeks
health-related quality of life assessed by the scale of SF-36
Time Frame: Change from baseline health-related quality of life at 12 weeks
self-reported health-related quality of life
Change from baseline health-related quality of life at 12 weeks
depression status assessed by the scale of Beck Depression inventory
Time Frame: Change from baseline depression status at 12 weeks
self-reported depression status
Change from baseline depression status at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tri-Service General Hospital

Investigators

  • Principal Investigator: Chia-Huei Lin, PhD, Tri-Service General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2019

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

July 23, 2021

First Submitted That Met QC Criteria

August 3, 2021

First Posted (Actual)

August 4, 2021

Study Record Updates

Last Update Posted (Actual)

August 4, 2021

Last Update Submitted That Met QC Criteria

August 3, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TSGHIRB: 1-108-05-070

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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