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

ConditionDynapenia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-85
SponsorKaohsiung Medical University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

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

Treatment groups

720 Participants
are divided into 2 treatment groups
Group A: Blood Flow Restriction Group (BFR)Experimental treatment 1 intervention
Group B: Conventional Resistance Training Group (CRT)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
week0(pre-intervention), week16(post-intervention)
2

Muscle Strength

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

Time frame
week0(pre-intervention), week16(post-intervention)
3

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)

Time frame
week0(pre-intervention), week16(post-intervention)
4

Height

Standard Measurements: Height, recorded in centimeters.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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