Trial Outcomes & Findings for Effect of Lifestyle Intervention in Patients With Chronic Kidney Disease on Fitness and Immune Function (NCT NCT05649657)
NCT ID: NCT05649657
Last Updated: 2025-08-19
Results Overview
cardiopulmonary exercise testing
COMPLETED
NA
34 participants
1 year
2025-08-19
Participant Flow
Participants were eligible for inclusion if they had been undergoing hemodialysis (HD) for more than 3 months, were over 20 years of age, had adequate dialysis (Kt/V \> 1.2), obtained approval from their nephrologist, and were able to walk independently for more than 10 meters. Exclusion criteria included recent hyperkalemia, medical or orthopedic conditions, muscular or psychological disorders, and a history of heart failure or inability to participate in cycling or exercise testing.
This study employed self-controlled design. Over the study period, each participant underwent assessments at five time points (T1, T2, T3, T4, and T5) with about 3 months between each time point. Between T1 and T2 was the control phase, the participants received usual medical care only. Between T2 and T4 was the training phase, exercise training and nutrition education were implemented. The T4-T5 follow-up phase monitored changes after training cessation with standard medical care only.
Participant milestones
| Measure |
Hemodialysis Partipants
Each participant will undergo 3-month control, 6-month intervention, and 3-month maintenance. There was no intervention in the control and maintenance phases.
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Self-controlled Study
n=22 Participants
A three-phase self-controlled design was used: 3-month control, 6-month training (72 sessions), and 3-month follow-up.
|
|---|---|
|
Age, Continuous
|
62 year
n=22 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=22 Participants
|
|
Region of Enrollment
Taiwan
|
22 Participants
n=22 Participants
|
|
peak VO2
|
14.8 ml/min/kg
n=22 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: 22 completed the 72-session training at T4 and after follow-up at T5
cardiopulmonary exercise testing
Outcome measures
| Measure |
Self-controlled Study
n=22 Participants
The participants receiving maintenance hemodialysis for over 3 months went through three phases: 3-month control, 6-month intervention, and 3-month maintenance. There was no intervention in the control and maintenance phases.
|
|---|---|
|
Peak Oxygen Consumption
|
3.07 ml/min/kg
Interval 1.06 to 5.95
|
PRIMARY outcome
Timeframe: 1 yearInterleukin (IL)-6 concentration was detected in plasma using the BD Cytometric Bead Array (CBA) Human Inflammatory Cytokines Kit (Becton-Dickinson) and analyzed with FCAP Array™ software .
Outcome measures
| Measure |
Self-controlled Study
n=22 Participants
The participants receiving maintenance hemodialysis for over 3 months went through three phases: 3-month control, 6-month intervention, and 3-month maintenance. There was no intervention in the control and maintenance phases.
|
|---|---|
|
Inflammatory Cytokines
|
2.84 pg/ml
Interval 2.01 to 6.08
|
Adverse Events
Self-controlled Study
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Shu-Chun Huang
New Taipei Municipal Tucheng Hospital, Chang Gung Memorial Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place