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

The Feasibility and Effects of Exercise Training Combined With Blood Flow Restriction Training on Exercise Capacity and Exercise Tolerance in Patients With Chronic Kidney Disease

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Behavioral: Aerobic exercise; Behavioral: Blood flow restriction; Behavioral: Resistance exercise; Behavioral: Disease and exercise suggestion

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kun-Ling Tasi, PhD; Phone Number: 886-6-2353535 Ext.5078; Email: Kunlingtsai@mail.ncku.edu.tw
• Study Contact Backup: Name: Ting-Ying Wu, B.S; Phone Number: 886-6-2353535 Ext.5078; Email: t66131036@gs.ncku.edu.tw

Study Locations

• Taiwan
  • Tainan, Taiwan, 701
    • Recruiting
    • National Cheng Kung University Hospital
    • Contact: Kun-Ling Tasi, PhD; Phone Number: 062353535 Ext. 6219; Email: Kunlingtsai@mail.ncku.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Healthy

Inclusion Criteria:

• Aged 20~85 years old

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

Inclusion criteria:

• 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)
• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: healthy; We will provide BFR combined with exercise	Behavioral: Aerobic exercise; The aerobic exercise intervention will utilize stationary bike. The program will be conducted 2 times per week over a 12 weeks; Behavioral: 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; Behavioral: Resistance exercise; The resistance exercise will bilateral leg extension. The program will be conducted 2 times per week over a 12 weeks; Behavioral: Disease and exercise suggestion; The participants will received self-care technique and home-based exercise approach
Active Comparator: CKD usual care group; We will provide patient education, home-based moderate to low-intensity rehabilitation	Behavioral: Disease and exercise suggestion; The participants will received self-care technique and home-based exercise approach
Active Comparator: CKD traditional rehabilitation group; We will provide aerobic exercise, resistance exercise training, and patient education	Behavioral: Aerobic exercise; The aerobic exercise intervention will utilize stationary bike. The program will be conducted 2 times per week over a 12 weeks; Behavioral: Resistance exercise; The resistance exercise will bilateral leg extension. The program will be conducted 2 times per week over a 12 weeks; Behavioral: Disease and exercise suggestion; The participants will received self-care technique and home-based exercise approach
Experimental: CKD BFR group; We will provide BFR combined with exercise and patient education	Behavioral: Aerobic exercise; The aerobic exercise intervention will utilize stationary bike. The program will be conducted 2 times per week over a 12 weeks; Behavioral: 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; Behavioral: Resistance exercise; The resistance exercise will bilateral leg extension. The program will be conducted 2 times per week over a 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: National Cheng Kung University
• Investigators: Principal Investigator: Kun-Ling Tasi, PhD, Department of Physical Therapy, National Cheng Kung University

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: December 3, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Physical Therapy Modalities; Patient Care; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Physical Conditioning, Human; Exercise; Blood Flow Restriction Therapy; Resistance Training
• Other Study ID Numbers: B-ER-113-450

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD sharing plan will be decided after summarized data being published

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No