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NCT Number: NCT07534150

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

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.

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Key information

Conditions

Dynapenia

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sports Biomechanics Laboratory

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

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%.

Primary outcomes

  1. Baseline Data

    Time frame: week0(pre-intervention), week16(post-intervention)

    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.

  2. Muscle Strength

    Time frame: week0(pre-intervention), week16(post-intervention)

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

  3. Muscle Function: The Short Physical Performance Battery (SPPB)

    Time frame: week0(pre-intervention), week16(post-intervention)

    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)

  4. Height

    Time frame: week0(pre-intervention), week16(post-intervention)

    Standard Measurements: Height, recorded in centimeters.

  5. Weight

    Time frame: week0(pre-intervention), week16(post-intervention)

    Standard Measurements: Weight, recorded in kilograms(kg)

  6. BMI

    Time frame: week0(pre-intervention), week16(post-intervention)

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

  7. Blood Pressure

    Time frame: week0(pre-intervention), week16(post-intervention)

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

  8. Circumferences

    Time frame: week0(pre-intervention), week16(post-intervention)

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

  9. SARC-F Questionnaire

    Time frame: week0(pre-intervention)

    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.

  10. Electromyography(EMG)

    Time frame: week0(pre-intervention), week16(post-intervention)

    Electromyography characteristics of Vastus Lateralis and Vastus Medialis

  11. Limb Occlusion Pressure(LOP)

    Time frame: week0(pre-intervention)

    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.

  12. Skeletal muscle mass

    Time frame: week0(pre-intervention), week16(post-intervention)

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

  13. Body fat percentage

    Time frame: week0(pre-intervention), week16(post-intervention)

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

  14. Estimated appendicular skeletal muscle mass

    Time frame: week0(pre-intervention), week16(post-intervention)

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

Study contacts

Contact information is provided by the study sponsor or research team.

LIN C Y Kaohsiung Medical University, Master

CONTACT

[email protected]

+8867-3121101 ext. #2646 #614

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 16, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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