Intradialytic Resistance and Flexibility Exercise in Hemodialysis Patients

January 28, 2026 updated by: Dilek GİBYELİ GENEK

Effects of Intradialytic Resistance and Flexibility Exercises on Clinical Outcomes in Hemodialysis Patients: A Pilot Randomized Controlled Trial

This study examined whether different types of exercise performed during hemodialysis sessions affect patients' health and quality of life. Patients receiving regular hemodialysis were assigned to resistance exercise, flexibility exercise, or usual care during dialysis. Changes in health-related outcomes were evaluated before and after the exercise period.

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

This single-center pilot study was conducted to explore the effects of exercise performed during hemodialysis on patients' health. Adult patients undergoing maintenance hemodialysis participated in one of three groups: resistance exercise, flexibility exercise, or usual care without exercise. The exercise programs were carried out during routine dialysis sessions under supervision.

Patients' clinical measurements and self-reported health outcomes were assessed at the start of the study and again after completion of the exercise period. The study was carried out between December 2020 and April 2021 following approval by the institutional ethics committee.

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.
49

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

  • Turkey (Türkiye)
    • Muğla
      • Muğla, Muğla, Turkey (Türkiye), 48000
        • Muğla Sıtkı Koçman University Training and Research Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 18 years or older
  • Receiving maintenance hemodialysis for at least 3 months
  • Stable clinical condition
  • Ability to participate in exercise during hemodialysis sessions
  • Provided written informed consent

Exclusion Criteria:

  • Acute illness or unstable cardiovascular disease
  • Severe musculoskeletal or neurological conditions limiting exercise
  • Recent hospitalization
  • Cognitive impairment preventing cooperation
  • Participation in another structured exercise program

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: None (Open Label)

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: Resistance Exercise
Participants performed supervised resistance exercise during routine hemodialysis sessions. Exercises were conducted three times per week during the first two hours of dialysis over the study period.
Behavioral: Resistance Exercise
A structured resistance exercise program performed during routine hemodialysis sessions under supervision.
Experimental: Flexibility Exercise
Participants performed supervised flexibility and stretching exercises during routine hemodialysis sessions. Exercises were conducted three times per week during the first two hours of dialysis over the study period.
Behavioral: Flexibility Exercise
A structured flexibility and stretching exercise program performed during routine hemodialysis sessions under supervision.
No Intervention: Usual Care (Control)
Participants received usual hemodialysis care without any structured exercise program during dialysis sessions.

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
Change in dialysis adequacy assessed by Kt/V (urea)
Time Frame: From baseline to 12 weeks
Change in dialysis adequacy measured by single-pool Kt/V (urea).
From baseline to 12 weeks
Change in dialysis adequacy assessed by urea reduction ratio (URR)
Time Frame: From baseline to 12 weeks
Change in dialysis adequacy measured by urea reduction ratio (URR), expressed as a percentage
From baseline to 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Short Form-36 (SF-36) Health-Related Quality of Life score
Time Frame: From baseline to 12 weeks

Change in health-related quality of life assessed using the Short Form-36 Health Survey (SF-36), a validated 36-item questionnaire.

SF-36 domain scores range from 0 to 100, with higher scores indicating better health-related quality of life.
From baseline to 12 weeks
Change in Beck Depression Inventory score
Time Frame: From baseline to 12 weeks
Change in depressive symptoms assessed using the Beck Depression Inventory (BDI). Scores range from 0 to 63, with higher scores indicating more severe depressive symptoms.
From baseline to 12 weeks
Change in body mass index (BMI)
Time Frame: From baseline to 12 weeks
Change in body mass index (BMI), calculated as weight in kilograms divided by height in meters squared (kg/m^2). Higher BMI indicates greater body mass relative to height.
From baseline to 12 weeks
Change in fat tissue index (FTI)
Time Frame: From baseline to 12 weeks
Change in fat tissue index (FTI) assessed by bioelectrical impedance analysis (BIA), calculated from fat tissue mass (FTM) normalized to height squared (kg/m^2).
From baseline to 12 weeks
Change in lean tissue index (LTI)
Time Frame: From baseline to 12 weeks
Change in lean tissue index (LTI) assessed by bioelectrical impedance analysis (BIA), calculated from lean tissue mass normalized to height squared (kg/m^2).
From baseline to 12 weeks
Change in physical function assessed by the 6-minute walk test (6MWT)
Time Frame: From baseline to 12 weeks
Change in physical function assessed using the 6-minute walk test (6MWT), measured as the total distance walked in meters.
From baseline to 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.
Dilek GİBYELİ GENEK

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: Dilek Gibyeli Genek, MD, Muğla Sıtkı Koçman University, Faculty of Medicine

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.
January 1, 2020

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.
April 1, 2021

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.
April 1, 2021

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).
January 22, 2026

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.
January 28, 2026

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.
February 5, 2026

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.
February 5, 2026

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.
January 28, 2026

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.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • HD-EX-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share individual participant data from this study.

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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