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

NCT07288905 | Recruiting

• 1 other identifier: B-ER-113-450
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (18)

• Heart rate variability (Standard Deviation of Normal-to-Normal Intervals, SDNN)

  Change form baseline (0 week) to follow up (16 weeks)

• Heart rate variability (Root Mean Square of Successive Differences, RMSSD)

  Change form baseline (0 week) to follow up (16 weeks)

• Heart rate variability (Low Frequency power, LF)

  Change form baseline (0 week) to follow up (16 weeks)

• Heart rate variability (High Frequency power, HF)

  Change from baseline (0 week) to follow-up (16 weeks)

• Heart rate variability (LF/HF Ratio)

  Change from baseline (0 week) to follow-up (16 weeks)

Study Arms (4)

healthy

EXPERIMENTAL

We will provide BFR combined with exercise

Behavioral: Aerobic exercise; Behavioral: Blood flow restriction; Behavioral: Resistance exercise; Behavioral: Disease and exercise suggestion

CKD usual care group

ACTIVE COMPARATOR

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

Behavioral: Disease and exercise suggestion

CKD traditional rehabilitation group

ACTIVE COMPARATOR

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

Behavioral: Aerobic exercise; Behavioral: Resistance exercise; Behavioral: Disease and exercise suggestion

CKD BFR group

EXPERIMENTAL

We will provide BFR combined with exercise and patient education

Behavioral: Aerobic exercise; Behavioral: Blood flow restriction; Behavioral: Resistance exercise

Interventions

Aerobic exercise 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; CKD traditional rehabilitation group; healthy

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

CKD BFR group; healthy

Resistance exercise BEHAVIORAL

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

CKD BFR group; CKD traditional rehabilitation group; healthy

Disease and exercise suggestion BEHAVIORAL

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

CKD traditional rehabilitation group; CKD usual care group; healthy

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 20\~85 years old

You may not qualify if:

• 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
• Aged 20\~85 years old
• eGFR\< 90 ml/min/1.73 m2 over 3 months
• Stable condition without worsening in the past 3 months

Sponsors & Collaborators

• National Cheng Kung University: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 701, Taiwan

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Exercise; Blood Flow Restriction Therapy; Resistance Training

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human

Study Officials

• Kun-Ling Tasi, PhD

  Department of Physical Therapy, National Cheng Kung University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair, Department of Physical Therapy

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: December 17, 2025
• Study Start: October 4, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2030
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)