NCT07390656

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

1.2 years

First QC Date

January 22, 2026

Last Update Submit

January 28, 2026

Conditions

Hemodialysis

Keywords

Intradialytic exerciseResistance exerciseFlexibility exerciseQuality of lifeClinical outcomes

Outcome Measures

Primary Outcomes (2)

  • Change in dialysis adequacy assessed by Kt/V (urea)

    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)

    Change in dialysis adequacy measured by urea reduction ratio (URR), expressed as a percentage

    From baseline to 12 weeks

Secondary Outcomes (6)

  • Change in Short Form-36 (SF-36) Health-Related Quality of Life score

    From baseline to 12 weeks

  • Change in Beck Depression Inventory score

    From baseline to 12 weeks

  • Change in body mass index (BMI)

    From baseline to 12 weeks

  • Change in fat tissue index (FTI)

    From baseline to 12 weeks

  • Change in lean tissue index (LTI)

    From baseline to 12 weeks

  • +1 more secondary outcomes

Study Arms (3)

Resistance Exercise

EXPERIMENTAL

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

Flexibility Exercise

EXPERIMENTAL

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

Usual Care (Control)

NO INTERVENTION

Participants received usual hemodialysis care without any structured exercise program during dialysis sessions.

Interventions

Resistance ExerciseBEHAVIORAL

A structured resistance exercise program performed during routine hemodialysis sessions under supervision.

Resistance Exercise
Flexibility ExerciseBEHAVIORAL

A structured flexibility and stretching exercise program performed during routine hemodialysis sessions under supervision.

Flexibility Exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muğla Sıtkı Koçman University Training and Research Hospital

Muğla, Muğla, 48000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Dilek Gibyeli Genek, MD

    Muğla Sıtkı Koçman University, Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to the nature of the exercise interventions, masking was not feasible.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were assigned to resistance exercise, flexibility exercise, or usual care groups and followed in parallel during the study period.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 22, 2026

First Posted

February 5, 2026

Study Start

January 1, 2020

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

February 5, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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

Locations

TU(1)