Exploring the Effects of Exercise Combined With BFRT on Healthy and Patients With CKD

NCT ID: NCT07288905

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-04

Study Completion Date

2030-12-31

Brief Summary

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Investigate the effects of exercise training on the cardiopulmonary function and exercise capacity in healthy and CKD patients

Detailed Description

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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.

Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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healthy

We will provide BFR combined with exercise

Group Type EXPERIMENTAL

Blood flow restriction

Intervention Type 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

Intervention Type 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

Intervention Type BEHAVIORAL

The participants will received self-care technique and home-based exercise approach

Aerobic exercise

Intervention Type BEHAVIORAL

The aerobic exercise intervention will utilize stationary bike. The program will be conducted 2 times per week over a 12 weeks

CKD usual care group

We will provide patient education, home-based moderate to low-intensity rehabilitation

Group Type ACTIVE_COMPARATOR

Disease and exercise suggestion

Intervention Type BEHAVIORAL

The participants will received self-care technique and home-based exercise approach

CKD traditional rehabilitation group

We will provide aerobic exercise, resistance exercise training, and patient education

Group Type ACTIVE_COMPARATOR

Resistance exercise

Intervention Type 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

Intervention Type BEHAVIORAL

The participants will received self-care technique and home-based exercise approach

Aerobic exercise

Intervention Type BEHAVIORAL

The aerobic exercise intervention will utilize stationary bike. The program will be conducted 2 times per week over a 12 weeks

CKD BFR group

We will provide BFR combined with exercise and patient education

Group Type EXPERIMENTAL

Blood flow restriction

Intervention Type 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

Intervention Type BEHAVIORAL

The resistance exercise will bilateral leg extension. The program will be conducted 2 times per week over a 12 weeks

Aerobic exercise

Intervention Type BEHAVIORAL

The aerobic exercise intervention will utilize stationary bike. The program will be conducted 2 times per week over a 12 weeks

Interventions

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Blood flow restriction

Blood flow restriction intervention will combined aerobic exercise and resistance exercise. The program will be conducted 2 times per week over a 12 weeks

Intervention Type BEHAVIORAL

Resistance exercise

The resistance exercise will bilateral leg extension. The program will be conducted 2 times per week over a 12 weeks

Intervention Type BEHAVIORAL

Disease and exercise suggestion

The participants will received self-care technique and home-based exercise approach

Intervention Type BEHAVIORAL

Aerobic exercise

The aerobic exercise intervention will utilize stationary bike. The program will be conducted 2 times per week over a 12 weeks

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

• Aged 20\~85 years old


* Aged 20\~85 years old
* eGFR\< 90 ml/min/1.73 m2 over 3 months
* Stable condition without worsening in the past 3 months
* Ability to understand and follow verbal commends and cooperate with an exercise training program

Exclusion Criteria

* Severe uncontrolled metabolic diseases (e.g., hyperthyroidism, diabetes, hypertension, hyperlipidemia, etc.)
* Severe pulmonary or cardiovascular diseases (e.g., pulmonary hypertension, chronic obstructive pulmonary disease (COPD), heart failure, cardiac arrhythmia)
* Presence of a cardiac pacemaker or a history of myocardial infarction within the past six months
* Severe musculoskeletal or neuromuscular disorders (e.g., advanced arthritis, limb amputation, post-polio syndrome, Parkinson's disease)
* Unstable vital signs (e.g., systolic blood pressure ≥180 mmHg, diastolic blood pressure ≥90 mmHg, requiring vasopressors, or resting heart rate \>100 bpm)
* Prone to bruising
* Recent inflection \< 1 month
* Pregnancy
* Kidney function impairment
* Cancer
* Simultaneously participating in other research

CKD


* Severe uncontrolled metabolic diseases (e.g., hyperthyroidism, diabetes, hypertension, hyperlipidemia, etc.)
* Severe pulmonary or cardiovascular diseases (e.g., pulmonary hypertension, chronic obstructive pulmonary disease (COPD), heart failure, cardiac arrhythmia)
* Presence of a cardiac pacemaker or a history of myocardial infarction within the past six months
* Severe musculoskeletal or neuromuscular disorders (e.g., advanced arthritis, limb amputation, post-polio syndrome, Parkinson's disease)
* Unstable vital signs (e.g., systolic blood pressure ≥180 mmHg, diastolic blood pressure ≥90 mmHg, requiring vasopressors, or resting heart rate \>100 bpm)
* Abnormal blood biochemical parameters (e.g., white blood cell count \<2500/mm³, hemoglobin \<8 mg/dL, total bilirubin \>3 mg/dL, liver enzymes (GOT/AST, GPT/ALT) \>3 times the upper limit of normal, platelet count \<75,000/mm³
* Sensory or motor dysfunctions that affect walking ability
* Diagnosed systemic diseases under ongoing treatment (e.g., systemic lupus erythematosus, cancer, malignancies).
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cheng Kung University

OTHER

Sponsor Role lead

Responsible Party

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Kun-Ling Tsai

Professor and Chair, Department of Physical Therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kun-Ling Tasi, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Physical Therapy, National Cheng Kung University

Locations

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National Cheng Kung University Hospital

Tainan, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Kun-Ling Tasi, PhD

Role: CONTACT

Phone: 886-6-2353535 Ext.5078

Email: [email protected]

Ting-Ying Wu, B.S

Role: CONTACT

Phone: 886-6-2353535 Ext.5078

Email: [email protected]

Facility Contacts

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Kun-Ling Tasi, PhD

Role: primary

Other Identifiers

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B-ER-113-450

Identifier Type: -

Identifier Source: org_study_id