CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 180 enrolled
Drug / intervention
Supervised exercise training +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT06417307
NCT06417307Phase 3Completed

Supervised Exercise Therapy on Mitochondrial Functions of Platelet and Lymphocyte in Patients With End-Stage Renal Disease on Hemodialysis

Chang Gung Memorial Hospital·interventional·Posted May 16, 2024·Updated Apr 4, 2025

In Brief

A Phase 3 clinical trial evaluating Supervised exercise training and Control group for Hemodialysis Complication. Completed, enrolled 180 participants across 1 site.

Detailed Summary

To improve aerobic capacity, muscular function and health-related quality of life in patients with end-stage renal disease (ESRD), regular exercise is recommended. Supervised intradialytic exercise with moderate intensity is an available approach to maintain patients' safety and compliance, and enhance physiological adaptations effectively. The exercise training effects of mitochondrial functions of lymphocyte in ESRD patients, like respiratory capacity, bioenergetic status and thrombosis/immunological regulation remained unclear. Method: ESRD patients (anticipated n=180) would conduct supervised exercise training therapy for 3 days a week for 6 months in the hospital and 3 months at home. Cardiopulmonary exercise therapy would be performed before and after the intervention. A high resolution respirometer and a flow cytometer are used to determine the oxygen consumption rate/mitochondrial respiration in mitochondria and subtypes of lymphocyte, respectively.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTaiwan
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedMay 16, 2024
Enrollment StartAug 1, 2021
Primary CompletionJul 31, 2024
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 2.1 years ago

Interventions

Supervised exercise trainingbehavioral

Participants perform Intradialytic cycling exercise training in the hospital for 6 months (24 weeks) and 3 months (12 weeks) at home. Exercise prescription: 50-60% maximal workload for 20-30 minutes, including low intensity warm-up and cool down (30% of maximal workload).

Control groupbehavioral

Maintain daily lifestyle until the end of the study. Receive no intervention/supplements.