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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tri-Service General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 25, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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