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To assess the efficacy of a 6-month lifestyle intervention in patients with end-stage renal disease(ESRD), we plan to conduct a self-controlled clinical trial. 34 participants receiving chronic HD will be enrolled. Each participant will go through three phases: 3-month control, 6-month intervention, and 3-month maintenance. No intervention will be performed in the control and maintenance phases. The lifestyle intervention will comprise care from a multidisciplinary team, including a nephrologist, nurse practitioner, physiatrist, and dietitian. The exercise training component is an in-hospital supervised training 2~3 times weekly for 6 months. Cyclic aerobic and resistance training will be performed. Assessment will be performed every three months and 5 times in total, including cardiopulmonary exercise testing, isokinetic quadriceps strength testing, hand grip strength, body composition analysis, Chinese Kidney Disease and Quality of Life questionnaire, self-recorded physical activity, and Mini Nutritional Assessment. The aim of this study is to assess the efficacy of a lifestyle intervention in patients with chronic kidney disease (CKD) on physical fitness, quality of life, and immunity. It is hypothesized that the lifestyle intervention will elicit a significant benefit in the aforementioned parameters and will last until the maintenance phase.
The prevalence of end-stage renal disease is high, especially in Taiwan. Cardiovascular diseases and infection are the major causes of morbidity. Though evidence is clear that exercise training in this population is beneficial to fitness、quality of life、morbidity, it is seriously underused. Poor physical fitness is known to associate with high-leveled systemic inflammation and immune dysregulation but the detailed relationship remains unclear in the ESRD population. Moreover, though exercise improves low physical fitness, available research concerning its effect on the pro-/anti-inflammatory immune response is scarce. Does supervised lifestyle intervention has the potential to improve physical fitness, and quality of life in patients receiving maintenance hemodialysis (HD)? To assess the efficacy of a 6-month lifestyle intervention in patients under HD, we plan to conduct a self-controlled clinical trial. No intervention will be performed in the control and maintenance phases. The lifestyle intervention will comprise care from a multidisciplinary team, including a nephrologist, nurse practitioner, physiatrist, and dietitian. The exercise training component is in-hospital supervise training 2~3 times weekly for 6 months. Cyclic aerobic and resistance training will be performed. Assessment will be performed every three months and 5 times in total, including cardiopulmonary exercise testing, isokinetic quadriceps strength testing, hand grip strength, body composition analysis, Chinese Kidney Disease and Quality of Life questionnaire, self-recorded physical activity, and Mini Nutritional Assessment. The aim of this study is to assess the efficacy of a lifestyle intervention in patients under HD on physical fitness, and quality of life. It is hypothesized that the lifestyle intervention will elicit a significant benefit in the aforementioned parameters and will last until the maintenance phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hemodialysis patients with exercise training intervention | Experimental | The participants under hemodialysis for over 3 months will go through three phases: 3-month control, 6-month intervention, and 3-month maintenance. No intervention will be performed in the control and maintenance phases |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclic aerobic and resistance training | Other | Two options for the participants to choose from. First, a home-based program. The participant will be requested to wear a heart rate recorder during home exercise. Second, a hospital-based program. The participants visit the rehabilitation center twice weekly to receive supervised exercise therapy. The exercise prescription comprises aerobic and resistance training. The intensity is set initially at ventilatory anaerobic threshold and gradually titrated up to respiratory compensatory point based on the breath-by-breath cardiopulmonary exercise testing. The duration is 25~35 minutes per session plus a 5-minute warm-up and 5-min cool-down. The frequency is 2~3 sessions per week and about 70 sessions in total. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Oxygen Consumption | cardiopulmonary exercise testing | 1 year |
| Inflammatory Cytokines | Interleukin (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 . | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shu-Chun Huang, MD, PhD | Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Taoyuan | 333 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41126503 | Derived | Huang SC, Fang JT, Huang YC, Lin CY, Hsiao CC. From gains to decline: effects of structured pre-dialytic exercise training and detraining on physical fitness, quality of life, and inflammation in haemodialysis patients. J Rehabil Med. 2025 Oct 22;57:jrm44067. doi: 10.2340/jrm.v57.44067. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Self-controlled Study | A three-phase self-controlled design was used: 3-month control, 6-month training (72 sessions), and 3-month follow-up. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Peak Oxygen Consumption | cardiopulmonary exercise testing | 22 completed the 72-session training at T4 and after follow-up at T5 | Posted | Median | Inter-Quartile Range | ml/min/kg | 1 year |
|
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1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Self-controlled Study | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shu-Chun Huang | New Taipei Municipal Tucheng Hospital, Chang Gung Memorial Hospital | 0952818169 | h0711@ms13.hinet.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 15, 2020 | Aug 2, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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|
| year |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| peak VO2 | Median | Inter-Quartile Range | ml/min/kg |
|
|
| Primary | Inflammatory Cytokines | Interleukin (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 . | Posted | Median | Inter-Quartile Range | pg/ml | 1 year |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 0 |
| 34 |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |