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

The Effects of Blood Flow Restriction Training Parameters on Lower Limb Muscle Function in Elderly Adults With Dynapenia: Mechanism and Intervention Outcomes

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dynapenia
• Intervention / Treatment: Device: Blood Flow Restriction; Other: Conventional Resistance Training

• Study Type: Interventional
• Enrollment (Estimated): 720
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: LIN C Y Kaohsiung Medical University, Master; Phone Number: #2646 #614 +8867-3121101; Email: jojojeff0205@gmail.com

Study Locations

• Taiwan
  • No. 100, Shiquan 1st Rd., Sanmin Dist., Kaohsiung City
    • Kaohsiung City, No. 100, Shiquan 1st Rd., Sanmin Dist., Kaohsiung City, Taiwan, 807
      • Sports Biomechanics Laboratory

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blood Flow Restriction Group (BFR); Receive low intensity lower limb resistance training with the use of Blood Flow Restriction	Device: Blood Flow Restriction; 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)
Active Comparator: Conventional Resistance Training Group (CRT); Receive traditional high intensity lower-limb resistance training	Other: Conventional Resistance Training; Leg Press Training, two sessions per week, three sets per session. 8-10 repetitions each set with intensity ranging from 60%-75%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University
• Investigators: Study Chair: GUO L Y Professor and Dean of the College of Health Science, Departmen, Ph.D., Department of Sports Science, Kaohsiung Medical University, Taiwan

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: March 29, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Elderly; Dynapenia; Blood Flow Restriction Training; Occlusion Pressure
• Additional Relevant MeSH Terms: Therapeutics; Physical Therapy Modalities; Patient Care; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Blood Flow Restriction Therapy
• Other Study ID Numbers: KMUHIRB-F(I)-20250145

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

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.

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.

• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

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