NCT07442240

Brief Summary

This study evaluated whether a rehabilitation program performed during hemodialysis sessions could improve daily functioning and mobility in adults receiving maintenance hemodialysis. Participants took part in either exercise-based rehabilitation, breathing muscle training, or usual care. The study compared changes in functional independence and mobility before and after the rehabilitation period.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

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

June 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
8.7 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

9 months

First QC Date

February 24, 2026

Last Update Submit

February 24, 2026

Conditions

Keywords

intradialytic exerciserehabilitationinspiratory muscle trainingcore stabilizationfunctional independencemobility

Outcome Measures

Primary Outcomes (1)

  • Six-Minute Walk Test

    Functional exercise capacity assessed as the distance walked in six minutes, measured according to standardized procedures.

    Baseline and after 10 weeks

Secondary Outcomes (6)

  • Timed Up and Go Test (TUG)

    Baseline and after 10 weeks

  • Five Times Sit-to-Stand Test (5STS)

    Baseline and after 10 weeks

  • Maximal Inspiratory Pressure (MIP)

    Baseline and after 10 weeks

  • Maximal Expiratory Pressure (MEP)

    Baseline and after 10 weeks

  • Forced Vital Capacity (FVC)

    Baseline and after 10 weeks

  • +1 more secondary outcomes

Study Arms (3)

Dynamic Lumbar Stabilization Exercise (DLSE)

EXPERIMENTAL

Participants received a supervised intradialytic dynamic lumbar stabilization exercise program three times per week for 10 weeks in addition to usual care.

Behavioral: Dynamic Lumbar Stabilization Exercises

Respiratory Muscle Training (RMT)

EXPERIMENTAL

Participants received supervised respiratory muscle training during hemodialysis sessions three times per week for 10 weeks in addition to usual care.

Behavioral: Respiratory Muscle Training

Control Group

NO INTERVENTION

Participants received routine nephrological care during hemodialysis without additional exercise or rehabilitation interventions.

Interventions

A structured intradialytic exercise program focusing on trunk stabilization and neuromuscular control, performed under supervision during hemodialysis sessions.

Dynamic Lumbar Stabilization Exercise (DLSE)

Respiratory muscle training performed during hemodialysis using threshold-based breathing exercises under supervision.

Respiratory Muscle Training (RMT)

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adults aged 25 to 45 years.
  • Diagnosis of chronic kidney disease undergoing maintenance hemodialysis.
  • Receiving hemodialysis for at least 6 months.
  • Hemodialysis schedule of three sessions per week, four hours per session.
  • Clinically stable at the time of enrollment.
  • Ability to participate in exercise and functional assessments.
  • Provided written informed consent.

You may not qualify if:

  • Acute medical conditions or unstable cardiovascular disease.
  • Severe musculoskeletal, neurological, or orthopedic disorders limiting exercise participation.
  • Severe cognitive impairment or inability to follow instructions.
  • Uncontrolled hypertension or other conditions contraindicating exercise.
  • Participation in another structured exercise or rehabilitation program during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Serpil Çolak, PT, PhD

    Bandırma Onyedi Eylül University

    PRINCIPAL INVESTIGATOR
  • Candan Z Algun, PT, PhD

    Medipol University

    STUDY DIRECTOR
  • Gürkan Yurteri, MD

    Rentek Diyaliz Merkezi

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessments were performed by a physiotherapist who was blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were allocated to one of three parallel groups: dynamic lumbar stabilization exercises, inspiratory muscle training, and a control group receiving usual care.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 24, 2026

First Posted

March 2, 2026

Study Start

June 1, 2016

Primary Completion

March 1, 2017

Study Completion

June 1, 2017

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because the study was conducted as part of an academic thesis and no data sharing plan was included in the original ethics approval.