Blood Flow Restriction Parameters and Lower Limb Function in Older Adults With Dynapenia

NCT07534150 | Not Yet Recruiting

• 1 other identifier: KMUHIRB-F(I)-20250145
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the first year is to collect limb occlusion pressure (LOP) measurements in older adults with varying levels of muscle health, which will serve as foundational data for subsequent investigations on blood flow restriction (BFR) combined with resistance training in individuals with dynapenia. This phase aims to examine LOP values and their potential influencing factors, including demographic and physiological characteristics such as age, height, body weight, blood pressure, waist circumference, body fat percentage, medical history of chronic diseases, and habitual physical activity. Muscle-related assessments will include skeletal muscle mass, thigh and calf circumference, handgrip strength, and lower limb muscle strength. Functional performance will be evaluated using the five-times sit-to-stand test and the SARC-F questionnaire for sarcopenia risk screening. LOP of the lower limbs will be measured using a BFR cuff system combined with a laboratory-developed blood flow detection device. The study will further investigate whether LOP values are associated with the aforementioned factors. The objective of the second year is to utilize high-density surface electromyography (dEMG) to analyze the electrophysiological characteristics of muscle contraction in individuals with sarcopenia under varying BFR pressures and resistance intensities. This includes examining motor unit recruitment patterns and recruitment thresholds, with the goal of identifying effective and appropriate BFR exercise parameters for this population. The objective of the third year is to investigate the effects of lower limb BFR combined with resistance training on functional performance in individuals with dynapenia. Building upon the findings from the first year, this phase will implement BFR resistance training interventions and evaluate both short-term and long-term effects. Through an experimental design, the study will assess changes in body composition, muscle strength, and functional performance following a four-month intervention, along with a three-month follow-up period, to determine whether participants can improve to a healthy status and maintain these improvements over time.

Conditions

Dynapenia

Keywords

Blood Flow Restriction Training; Elderly; Dynapenia; Occlusion Pressure

Outcome Measures

Primary Outcomes (14)

• Baseline Data

  Collect data on participants' demographics including gender, age, education level, living situation, lifestyle habits (such as alcohol consumption and smoking), and health status with chronic disease history. Daily activity patterns are assessed using the International Physical Activity Questionnaire - Short Self-Administered Taiwanese Chinese Version (IPAQ), which surveys participants' activities of different intensities over the past seven days.

  week0(pre-intervention), week16(post-intervention)

• Muscle Strength

  Hand Grip Strength measured via a Dynamometer, recorded in kg Knee Extensor Strength measured via a hand-held Dynamometer

  week0(pre-intervention), week16(post-intervention)

• Muscle Function: The Short Physical Performance Battery (SPPB)

  The Short Physical Performance Battery (SPPB) evaluates lower extremity function through three tasks: standing balance (side-by-side, semi-tandem, tandem), 4-meter gait speed, and a 5-repetition chair stand test. Each task is scored from 0 (inability to complete) to 4 (best performance). The three component scores are summed for a total score ranging from 0 to 12, with higher scores indicating better physical performance. Unit of Measure: scores on a scale (points)

  week0(pre-intervention), week16(post-intervention)

• Height

  Standard Measurements: Height, recorded in centimeters.

  week0(pre-intervention), week16(post-intervention)

• Weight

  Standard Measurements: Weight, recorded in kilograms(kg)

  week0(pre-intervention), week16(post-intervention)

• BMI

  weight and height will be combined to report BMI in kg/m\^2

  week0(pre-intervention), week16(post-intervention)

• Blood Pressure

  Measured via a Blood Pressure Monitor, Systolic Blood Pressure and Diastolic Blood Pressure will be recorded in mmHg

  week0(pre-intervention), week16(post-intervention)

• Circumferences

  Waist line, Thigh Circumference, Calf Circumference will be using standard tape measure and recorded in centimeter(cm)

  week0(pre-intervention), week16(post-intervention)

• SARC-F Questionnaire

  The questionnaire consists of five items, each scored 0, 1, or 2, with higher scores indicating greater difficulty for the participant. The total score ranges from 0 to 10. The items assess difficulty in Strength, Assistance in walking, Rising from a chair, Climbing, and Fall. A SARC-F score greater than 4 indicates a population at risk for sarcopenia.

  week0(pre-intervention)

• Electromyography(EMG)

  Electromyography characteristics of Vastus Lateralis and Vastus Medialis

  week0(pre-intervention), week16(post-intervention)

• Limb Occlusion Pressure(LOP)

  Measured in a seated position with the knee fully extended, using a laboratory-developed blood flow occlusion detection system. During the measurement, a manually inflated pressure cuff was placed at the proximal thigh near the hip joint, while a photoplethysmography (PPG) sensor and a temperature sensor were positioned over the dorsalis pedis artery on the anterior aspect of the ankle to detect distal PPG and temperature signals.

  week0(pre-intervention)

• Skeletal muscle mass

  Measured by Bioelectrical Impedance Analysis(BIA), recorded in kilograms(kg)

  week0(pre-intervention), week16(post-intervention)

• Body fat percentage

  Measured by Bioelectrical Impedance Analysis(BIA), recorded in percentage(%)

  week0(pre-intervention), week16(post-intervention)

• Estimated appendicular skeletal muscle mass

  Measured by Bioelectrical Impedance Analysis(BIA), recorded in kilograms(kg)

  week0(pre-intervention), week16(post-intervention)

Study Arms (2)

Blood Flow Restriction Group (BFR)

EXPERIMENTAL

Receive low intensity lower limb resistance training with the use of Blood Flow Restriction

Device: Blood Flow Restriction

Conventional Resistance Training Group (CRT)

ACTIVE COMPARATOR

Receive traditional high intensity lower-limb resistance training

Other: Conventional Resistance Training

Interventions

Blood Flow Restriction DEVICE

Leg Press Training. two sessions per week. BFR cuff set at 50-65% of Limb Occlusion Pressure, three sets of 30-15-15 repetitions in a total of 3 sets. Intensity set at 20-30% of 1RM. Device: Delfi Personal Tourniquet System (PTS)

Blood Flow Restriction Group (BFR)

Conventional Resistance Training OTHER

Leg Press Training, two sessions per week, three sets per session. 8-10 repetitions each set with intensity ranging from 60%-75%.

Conventional Resistance Training Group (CRT)

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 55 years and older.
• No regular physical activity within the past three months, defined as exercising no more than twice per week.
• No cognitive impairment and able to follow exercise and assessment instructions.

You may not qualify if:

• Have contraindications to exercise, such as severe musculoskeletal problems, osteoporosis, deep vein thrombosis, or coagulation disorders.
• Have comorbid conditions that are severe or end-stage, such as stroke diagnosed by a neurologist, diabetes with severe complications (e.g., retinopathy), or cardiovascular disease including heart failure, coronary ischemia, or arrhythmia.
• Have high-risk factors for exercise, such as uncontrolled hypertension (systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg), angina or chest tightness during exercise, or deep vein thrombosis.
• Have a history of hematologic disorders or are currently taking blood-related medications, such as hormones or anticoagulants.
• Are expected to move out of the local community within three months.

Sponsors & Collaborators

• Kaohsiung Medical University: lead

Study Sites (1)

Sports Biomechanics Laboratory

Kaohsiung City, No. 100, Shiquan 1st Rd., Sanmin Dist., Kaohsiung City, 807, Taiwan

Location

MeSH Terms

Interventions

Blood Flow Restriction Therapy

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• GUO L Y Professor and Dean of the College of Health Science, Departmen, Ph.D.

  Department of Sports Science, Kaohsiung Medical University, Taiwan

  STUDY CHAIR

Central Study Contacts

LIN C Y Kaohsiung Medical University, Master

CONTACT

+8867-3121101; jojojeff0205@gmail.com

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: Principal Investigator

Model Details: To investigate the effects of lower limb Blood Flow Restriction(BFR) combined with resistance training on functional performance in individuals with dynapenia. Building upon the findings from the first year, this phase will implement BFR resistance training interventions and evaluate short-term and long-term effects. Through an experimental design, the study will assess changes in body composition, muscle strength, and functional performance following a four-month intervention, along with a three-month follow-up period, to determine whether participants can improve to a healthy status and maintain these improvements over time.

Study Record Dates

• First Submitted: March 29, 2026
• First Posted: April 16, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 16, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: De-identified individual participant data (IPD) and supporting information will be available starting 2 years after the publication of the primary study results and will remain accessible for 5 years.
• Access Criteria: The related supporting documents will only be made available to qualified researchers affiliated with academic institutions, medical organizations, or public health agencies. Applicants must submit a detailed research proposal and ethical approval document, and access will be granted only upon approval.

Locations

TW (1)