DynapeniaNCT07534150
Blood Flow Restriction Parameters and Lower Limb Function in Older Adults With Dynapenia
A study testing Blood Flow Restriction and Conventional Resistance Training in people with Dynapenia, run by Kaohsiung Medical University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Dynapenia
- What is being tested?
- Blood Flow Restriction and Conventional Resistance Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
LIN C Y Kaohsiung Medical University, Master contact
Taiwan1 site
Sports Biomechanics Laboratory
Kaohsiung City, No. 100, Shiquan 1st Rd., Sanmin Dist., Kaohsiung City, 807
About this study
Official title: 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.
- Conditions
- Dynapenia
- Being tested
- Blood Flow Restriction, Conventional Resistance Training
- Keywords
- Blood Flow Restriction Training, Elderly, Dynapenia, Occlusion Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow RestrictionDevice
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 TrainingOther
Leg Press Training, two sessions per week, three sets per session. 8-10 repetitions each set with intensity ranging from 60%-75%.
| Study group | Role | What they receive |
|---|---|---|
| Blood Flow Restriction Group (BFR) | Experimental | Receive low intensity lower limb resistance training with the use of Blood Flow Restriction Receives: Device: Blood Flow Restriction |
| Conventional Resistance Training Group (CRT) | Active comparator | Receive traditional high intensity lower-limb resistance training Receives: Other: Conventional Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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)
Measured: week0(pre-intervention), week16(post-intervention)
Height
Standard Measurements: Height, recorded in centimeters.
Measured: week0(pre-intervention), week16(post-intervention)
Weight
Standard Measurements: Weight, recorded in kilograms(kg)
Measured: week0(pre-intervention), week16(post-intervention)
BMI
weight and height will be combined to report BMI in kg/m^2
Measured: 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
Measured: week0(pre-intervention), week16(post-intervention)
Circumferences
Waist line, Thigh Circumference, Calf Circumference will be using standard tape measure and recorded in centimeter(cm)
Measured: 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.
Measured: week0(pre-intervention)
Electromyography(EMG)
Electromyography characteristics of Vastus Lateralis and Vastus Medialis
Measured: 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.
Measured: week0(pre-intervention)
Skeletal muscle mass
Measured by Bioelectrical Impedance Analysis(BIA), recorded in kilograms(kg)
Measured: week0(pre-intervention), week16(post-intervention)
Body fat percentage
Measured by Bioelectrical Impedance Analysis(BIA), recorded in percentage(%)
Measured: week0(pre-intervention), week16(post-intervention)
Estimated appendicular skeletal muscle mass
Measured by Bioelectrical Impedance Analysis(BIA), recorded in kilograms(kg)
Measured: week0(pre-intervention), week16(post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DynapeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chih-Yu Lin, Kaohsiung Medical University
- Investigators
- GUO L Y Professor and Dean of the College of Health Science, Departmen, Ph.D., Study chair, Department of Sports Science, Kaohsiung Medical University, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534150
- Sponsor's protocol ID
- KMUHIRB-F(I)-20250145
- Status last verified
- Apr 2025
- First submitted
- 29 Mar 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Blood Flow Restriction Training Parameters on Lower Limb Muscle Function in Elderly Adults With Dynapenia: Mechanism and Intervention Outcomes
- ClinicalTrials.gov ID
- NCT07534150
- Acronym / sponsor ID
- KMUHIRB-F(I)-20250145
- Conditions
- Dynapenia
- Keywords
- Blood Flow Restriction Training, Elderly, Dynapenia, Occlusion Pressure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Kaohsiung Medical UniversityUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Blood Flow Restriction Group (BFR) | Experimental | Device: Blood Flow RestrictionReceive low intensity lower limb resistance training with the use of Blood Flow Restriction |
| Conventional Resistance Training Group (CRT) | Active comparator | Other: Conventional Resistance TrainingReceive traditional high intensity lower-limb resistance training |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Flow RestrictionLeg 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) | Device | Blood Flow Restriction Group (BFR) |
| Conventional Resistance TrainingLeg Press Training, two sessions per week, three sets per session. 8-10 repetitions each set with intensity ranging from 60%-75%. | Other | Conventional Resistance Training Group (CRT) |
Primary outcome
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.
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
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)
Height
Time frame: week0(pre-intervention), week16(post-intervention)
Standard Measurements: Height, recorded in centimeters.
Weight
Time frame: week0(pre-intervention), week16(post-intervention)
Standard Measurements: Weight, recorded in kilograms(kg)
BMI
Time frame: week0(pre-intervention), week16(post-intervention)
weight and height will be combined to report BMI in kg/m^2
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
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)
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.
Electromyography(EMG)
Time frame: week0(pre-intervention), week16(post-intervention)
Electromyography characteristics of Vastus Lateralis and Vastus Medialis
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.
Skeletal muscle mass
Time frame: week0(pre-intervention), week16(post-intervention)
Measured by Bioelectrical Impedance Analysis(BIA), recorded in kilograms(kg)
Body fat percentage
Time frame: week0(pre-intervention), week16(post-intervention)
Measured by Bioelectrical Impedance Analysis(BIA), recorded in percentage(%)
Estimated appendicular skeletal muscle mass
Time frame: week0(pre-intervention), week16(post-intervention)
Measured by Bioelectrical Impedance Analysis(BIA), recorded in kilograms(kg)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Dynapenia
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Effectiveness of Whole Body Vibration on Health Outcomes in Older Adults With Dynapenic Abdominal Obesity
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Not yet recruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
LIN C Y Kaohsiung Medical University, Master contact
GUO L Y Professor and Dean of the College of Health Science, Departmen, Ph.D. study chair
Department of Sports Science, Kaohsiung Medical University, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction and Conventional Resistance Training in people with Dynapenia, run by Kaohsiung Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LIN C Y Kaohsiung Medical University, Master (+8867-3121101 ext. #2646 #614, jojojeff0205@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Data (time frame: week0(pre-intervention), week16(post-intervention)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.