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Investigate the effects of exercise training on the cardiopulmonary function and exercise capacity in healthy and CKD patients
Chronic kidney disease (CKD) is a condition characterized by impaired kidney function lasting for more than 3 months, as estimated by the glomerular filtration rate (eGFR), which is classified into stages 1 to 5. Common symptoms include swelling, fatigue, and high blood pressure. Previous studies have indicated that physical inactivity in patients with CKD, often due to fatigue, leads to decreased physical fitness. In addition, secondary complications such as muscle mass loss and weakness are frequently observed, especially in the advanced stages of CKD.
To address this vicious cycle, aerobic and resistance training have been shown to mitigate these effects. Previous studies have reported that such exercise interventions can reduce fatigue and improve VO₂ peak in individuals with CKD. However, these exercise programs often involve high loads and frequencies, which may not be feasible for some CKD patients, particularly those with comorbidities such as diabetes or cardiovascular disease.
The effectiveness of blood flow restriction (BFR) exercise compared with high-load training has been demonstrated in older adults, showing improvements in functional ability and muscular adaptation. Therefore, the purpose of this study is to investigate the effects of incorporating blood flow restriction during exercise on cardiopulmonary function and exercise capacity in patients with CKD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| healthy | Experimental | We will provide BFR combined with exercise |
|
| CKD usual care group | Active Comparator | We will provide patient education, home-based moderate to low-intensity rehabilitation |
|
| CKD traditional rehabilitation group | Active Comparator | We will provide aerobic exercise, resistance exercise training, and patient education |
|
| CKD BFR group | Experimental | We will provide BFR combined with exercise and patient education |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic exercise | Behavioral | The aerobic exercise intervention will utilize stationary bike. The program will be conducted 2 times per week over a 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diaphragm excursion and thickness | Diaphragm excursion (unit: mm) and thickness (unit: mm) are examined by diaphragmatic ultrasound when a participant performs maximal inspiration and expiration | Change from baseline (0 week) to follow up (16 weeks) |
| Exercise capacity | A cardiopulmonary exercise test collects gases (including measures of oxygen consumption in ml/kg/min), which can be used to estimate exercise capacity | Change form baseline (0 week) to follow up (16 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate variability (Standard Deviation of Normal-to-Normal Intervals, SDNN) | Heart rate variability (HRV) is examined to assess the autonomic nervous system. Standard Deviation of Normal-to-Normal Intervals (SDNN, in ms)reflects overall heart rate variability and autonomic function | Change form baseline (0 week) to follow up (16 weeks) |
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Healthy
Inclusion Criteria:
• Aged 20~85 years old
Exclusion Criteria:
CKD
Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kun-Ling Tasi, PhD | Contact | 886-6-2353535 Ext.5078 | Kunlingtsai@mail.ncku.edu.tw | |
| Ting-Ying Wu, B.S | Contact | 886-6-2353535 Ext.5078 | t66131036@gs.ncku.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Kun-Ling Tasi, PhD | Department of Physical Therapy, National Cheng Kung University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cheng Kung University Hospital | Recruiting | Tainan | 701 | Taiwan |
IPD sharing plan will be decided after summarized data being published
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D000090003 | Blood Flow Restriction Therapy |
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Blood flow restriction | Behavioral | Blood flow restriction intervention will combined aerobic exercise and resistance exercise. The program will be conducted 2 times per week over a 12 weeks |
|
| Resistance exercise | Behavioral | The resistance exercise will bilateral leg extension. The program will be conducted 2 times per week over a 12 weeks |
|
| Disease and exercise suggestion | Behavioral | The participants will received self-care technique and home-based exercise approach |
|
| Heart rate variability (Root Mean Square of Successive Differences, RMSSD) |
Root Mean Square of Successive Differences (RMSSD in ms) represents short-term HRV and parasympathetic activity |
| Change form baseline (0 week) to follow up (16 weeks) |
| Heart rate variability (Low Frequency power, LF) | Low frequency power (LF, in ms²) reflects both sympathetic and parasympathetic modulation. | Change form baseline (0 week) to follow up (16 weeks) |
| Heart rate variability (High Frequency power, HF) | High frequency power (HF in ms²) reflects parasympathetic (vagal) activity. | Change from baseline (0 week) to follow-up (16 weeks) |
| Heart rate variability (LF/HF Ratio) | LF/HF ratio represents sympathovagal balance. | Change from baseline (0 week) to follow-up (16 weeks) |
| Pulmonary function test | Pulmonary function test is examined by spirometry, which measures the ability to inhale and exhale air over time. The results include forced vital capacity (FVC in L), forced exploratory volume in the first second (FEV1 in L), and the FVC/FEV1 ratio. | Change from baseline (0 week) to follow up (16 weeks) |
| Functional capacity | Functional capacity is examined by 6 minute walking test (6MWT, in m) | Change from baseline (0 week) to follow up (16 weeks) |
| Functional ability | Functional ability is examined using the Timed Up and Go (TUG) test, where the time taken (in seconds) to complete the test is recorded. | Change from baseline (0 week) to follow up (16 weeks) |
| Sit-and-Reach Test | Flexibility is examined by the sit and reach test (unit: cm). | Change from baseline (0 week) to follow up (16 weeks) |
| Handgrip Strength | Maximal voluntary handgrip strength. (unit: N) | Change from baseline (0 week) to follow-up (16 weeks) |
| Upper Limb Muscle Strength | Maximal voluntary contraction of upper limb muscles. (unit: N) | Change from baseline (0 week) to follow up (16 weeks) |
| Neck Muscle Strength | Maximal voluntary contraction of neck muscles. (unit: N) | Change from baseline (0 week) to follow up (16 weeks) |
| Knee Extensor Strength | Maximal voluntary contraction of the knee extensor muscles. (unit: N) | Change from baseline (0 week) to follow-up (16 weeks) |
| Maximum respiratory pressure | Maximum respiratory pressure is measured using a manometer, which records both maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP), in cmH₂O. | Change from baseline (0 week) to follow up (20 weeks) |
| Fatigue Severity Scale (FSS) | the Fatigue Severity Scale (FSS) is a 7-point scale questionnaire that measures the patient's level of fatigue. It contains 9 questions, and a total score of 36 points or higher indicates that the patient may be experiencing clinically significant fatigue and requires further evaluation. | Change form baseline (0 week) to follow up (16 weeks) |
| Kidney Disease Quality of Life (KDQOL) | The Kidney Disease Quality of Life (KDQOL) questionnaire is a standard tool for patients with kidney disease. It contains several subscales, and the raw scores are converted into normalized scores, with higher scores indicating better quality of life. | Change form baseline (0 week) to follow up (16 weeks) |
| Modified Medical Research Council (mMRC) | The modified Medical Research Council (mMRC) dyspnea scale consists of 4 levels that describe respiratory difficulty during daily activities; higher levels indicate more severe symptoms. | Change from baseline (0 week) to follow up (16 weeks) |
| Short Form-36 (SF-36) | The Short Form-36 (SF-36) measures physical and social health status, with higher scores representing better overall health | Change from baseline (0 week) to follow up (16 weeks) |
| 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 |
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |