Sarcopenia in ElderlyNCT07689487
Effects of Cyclical Blood Flow Restriction Exercise on Muscle Hypertrophy and Capillaries in Older Adults
A study testing Blood Flow Restriction (BFR) and Conventional Low-Load Resistance Exercise in people with Sarcopenia in Elderly and Muscle Atrophy, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study was to learn if low-load resistance exercise combined with cyclical blood flow restriction (BFR) could improve small blood vessel structure and muscle size in older adults. Skeletal muscle thinning and the loss of tiny blood vessels (capillaries) commonly happen as people age. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia in Elderly, Muscle Atrophy, Aging
- What is being tested?
- Blood Flow Restriction (BFR) and Conventional Low-Load Resistance Exercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2026to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 50 years or older.
- Recreationally active, defined as participating in light-to-moderate physical activity 2 or more days per week.
- No structured resistance training within the preceding six months.
- Free from cardiovascular disease, neurological conditions, or musculoskeletal injury contraindicating resistance exercise.
- Able to provide written informed consent before enrollment.
Who cannot join
- Current use of anticoagulant or vasoactive medication.
- History of deep vein thrombosis (DVT).
- Resting systolic blood pressure greater than 160 mmHg.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz University, Faculty of Sport Sciences
Antalya, Antalya, 07058
About this study
Official title: Eight Weeks of Cyclical Blood Flow Restriction Exercise Induces Regional Microvascular Remodeling and Muscle Hypertrophy in Older Adults: A Three-Arm Randomized Controlled Trial
The purpose of this study was to learn if low-load resistance exercise combined with cyclical blood flow restriction (BFR) could improve small blood vessel structure and muscle size in older adults.
Skeletal muscle thinning and the loss of tiny blood vessels (capillaries) commonly happen as people age. While lifting heavy weights can help stop this, heavy loads are often not suitable for older adults with joint pain or other health conditions. Low-load exercise with BFR involves wearing inflatable cuffs on the upper arms that temporarily slow down blood flow, which can trigger positive changes in muscles and blood vessels without needing heavy weights.
Read more
Researchers compared three groups of older adults:
- One group performed low-load upper-body exercises while wearing cyclical BFR cuffs.
- A second group performed the exact same exercises at the same low load but without wearing cuffs.
- A third group maintained their normal daily activities without participating in any structured exercise program.
Participants in the exercise groups trained 3 days a week for 8 weeks. Researchers used video capillaroscopy (a specialized camera at the fingernail base) to examine changes in tiny blood vessels and ultrasound imaging to measure arm muscle thickness before and after the 8-week period.
Read the detailed description
The goal of this parallel-group randomized controlled trial was to determine the chronic physiological effects of an 8-week cyclical blood flow restriction (BFR) training protocol on microvascular geometry and structural muscle hypertrophy in older adults.
Heavy mechanical resistance training is a primary countermeasure against age-related sarcopenia, yet joint pathologies or cardiovascular comorbidities frequently limit its application in older populations. Low-load resistance training combined with BFR offers a load-sparing alternative by creating localized hypoxia and metabolite accumulation, which stimulate vascular endothelial growth factor (VEGF) and downstream angiogenic pathways. A cyclical BFR approach, where cuff pressure was systematically inflated and deflated, was used to optimize these adaptations via oscillatory shear stress while improving cardiovascular tolerability compared to continuous occlusion protocols.
Participants were stratified by sex, age, baseline strength, and height, and then randomized into one of three arms:
- Cyclical BFR Group: Low-load resistance training (20-40% 1RM) across four upper-body exercises with automated pneumatic cuffs delivering 8 cycles of 30 seconds inflation and 5 seconds deflation.
- TRAINING Group: Identical low-load resistance training protocol performed without vascular restriction.
- CONTROL Group: Non-exercise control maintaining habitual lifestyle activities.
The intervention spanned 8 weeks with a training frequency of 3 sessions per week. Co-primary structural adaptations were tracked using non-invasive surrogates: nailfold video capillaroscopy to record arterial, apical, and venous capillary diameters, and B-mode ultrasonography to assess structural changes in biceps brachii and triceps brachii muscle thickness. Linear mixed models were utilized to analyze Group x Time interactions to verify if cyclical BFR demonstrated an adaptive superiority over standard low-load protocols.
- Conditions
- Sarcopenia in Elderly, Muscle Atrophy, Aging
- Being tested
- Blood Flow Restriction (BFR), Conventional Low-Load Resistance Exercise
- Keywords
- blood flow restriction, aging, nailfold capillaroscopy, muscle hypertrophy, angiogenesis, sarcopenia, KAATSU
- Medical subject headings
- Muscular Atrophy, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction (BFR)Device
Vascular restriction administered using an automated cyclical pneumatic device (KAATSU Cycle 2.0) with 40 mm cuffs placed proximally on both arms. Protocol consists of 8 cycles of 30 seconds of inflation followed by 5 seconds of deflation per cycle, individually calibrated by capillary refill time and verified by Doppler ultrasound.
Conventional Low-Load Resistance ExerciseBehavioural
Upper-body resistance exercise training encompassing four movements: biceps curl, triceps pushdown, lat pulldown, and chest press. Executed under a controlled 4x12 repetition scheme at an intensity of 20-40% 1RM, performed 3 days per week for a duration of 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Cyclical Blood Flow Restriction (BFR) Group | Experimental | Older adults who performed low-load upper-body resistance exercise (20-40% 1RM) combined with cyclical blood flow restriction using pneumatic cuffs (40 mm width, 8 cycles of 30 s inflation/5 s deflation). Sessions were performed 3 days per week for 8 weeks. Receives: Device: Blood Flow Restriction (BFR); Behavioral: Conventional Low-Load Resistance Exercise |
| Low-Load Training Group | Active comparator | Older adults who performed the identical low-load upper-body resistance exercise protocol (4 exercises, 4x12 repetitions at 20-40% 1RM) 3 days per week for 8 weeks, but without wearing restriction cuffs. Receives: Behavioral: Conventional Low-Load Resistance Exercise |
| Non-Exercise Control Grou | No intervention | Older adults who maintained their habitual lifestyle and daily physical activities without participating in any structured resistance training program for 8 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nailfold Capillary Diameter
Microvascular morphology changes measured at three anatomical regions: the arterial (afferent) limb, the apical portion, and the venous (efferent) limb using nailfold video capillaroscopy.
Measured: Baseline and post-intervention (at the end of week 8)
Upper-Arm Muscle Thickness
Structural muscle hypertrophy of the biceps brachii and triceps brachii muscles of the dominant arm, assessed via B-mode ultrasonography.
Measured: Baseline and post-intervention (at the end of week 8).
Secondary outcomes (3)
Total Body Mass
Changes in total body mass measured via bioelectrical impedance analysis.
Measured: Baseline and post-intervention (at the end of week 8)
Body Fat Percentage
Changes in body fat percentage measured via bioelectrical impedance analysis.
Measured: Baseline and post-intervention (at the end of week 8)
Fat Mass
Changes in fat mass measured via bioelectrical impedance analysis.
Measured: Baseline and post-intervention (at the end of week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start1 Feb 2026
- Primary completion1 May 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcopenia in ElderlyStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Collaborators
- Akdeniz University, Scientific Research Projects Coordination Unit
- Responsible party
- Principal investigator, Tuba Melekoğlu, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689487
- Sponsor's protocol ID
- TYL-2025-6950
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared to protect participant privacy and confidentiality, in accordance with the institutional ethics committee approval. However, de-identified data may be made available to qualified researchers upon reasonable request directed to the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eight Weeks of Cyclical Blood Flow Restriction Exercise Induces Regional Microvascular Remodeling and Muscle Hypertrophy in Older Adults: A Three-Arm Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07689487
- Acronym / sponsor ID
- TYL-2025-6950
- Conditions
- Sarcopenia in Elderly, Muscle Atrophy, Aging
- Keywords
- blood flow restriction, aging, nailfold capillaroscopy, muscle hypertrophy, angiogenesis, sarcopenia, KAATSU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Collaborators
- Akdeniz University, Scientific Research Projects Coordination Unit
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 8 Jul 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 purpose of this study was to learn if low-load resistance exercise combined with cyclical blood flow restriction (BFR) could improve small blood vessel structure and muscle size in older adults.
Skeletal muscle thinning and the loss of tiny blood vessels (capillaries) commonly happen as people age. While lifting heavy weights can help stop this, heavy loads are often not suitable for older adults with joint pain or other health conditions. Low-load exercise with BFR involves wearing inflatable cuffs on the upper arms that temporarily slow down blood flow, which can trigger positive changes in muscles and blood vessels without needing heavy weights.
Researchers compared three groups of older adults:
- One group performed low-load upper-body exercises while wearing cyclical BFR cuffs.
- A second group performed the exact same exercises at the same low load but without wearing cuffs.
- A third group maintained their normal daily activities without participating in any structured exercise program.
Participants in the exercise groups trained 3 days a week for 8 weeks. Researchers used video capillaroscopy (a specialized camera at the fingernail base) to examine changes in tiny blood vessels and ultrasound imaging to measure arm muscle thickness before and after the 8-week period.
Detailed description
The goal of this parallel-group randomized controlled trial was to determine the chronic physiological effects of an 8-week cyclical blood flow restriction (BFR) training protocol on microvascular geometry and structural muscle hypertrophy in older adults.
Heavy mechanical resistance training is a primary countermeasure against age-related sarcopenia, yet joint pathologies or cardiovascular comorbidities frequently limit its application in older populations. Low-load resistance training combined with BFR offers a load-sparing alternative by creating localized hypoxia and metabolite accumulation, which stimulate vascular endothelial growth factor (VEGF) and downstream angiogenic pathways. A cyclical BFR approach, where cuff pressure was systematically inflated and deflated, was used to optimize these adaptations via oscillatory shear stress while improving cardiovascular tolerability compared to continuous occlusion protocols.
Participants were stratified by sex, age, baseline strength, and height, and then randomized into one of three arms:
- Cyclical BFR Group: Low-load resistance training (20-40% 1RM) across four upper-body exercises with automated pneumatic cuffs delivering 8 cycles of 30 seconds inflation and 5 seconds deflation.
- TRAINING Group: Identical low-load resistance training protocol performed without vascular restriction.
- CONTROL Group: Non-exercise control maintaining habitual lifestyle activities.
The intervention spanned 8 weeks with a training frequency of 3 sessions per week. Co-primary structural adaptations were tracked using non-invasive surrogates: nailfold video capillaroscopy to record arterial, apical, and venous capillary diameters, and B-mode ultrasonography to assess structural changes in biceps brachii and triceps brachii muscle thickness. Linear mixed models were utilized to analyze Group x Time interactions to verify if cyclical BFR demonstrated an adaptive superiority over standard low-load protocols.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cyclical Blood Flow Restriction (BFR) Group | Experimental | Device: Blood Flow Restriction (BFR), Behavioral: Conventional Low-Load Resistance ExerciseOlder adults who performed low-load upper-body resistance exercise (20-40% 1RM) combined with cyclical blood flow restriction using pneumatic cuffs (40 mm width, 8 cycles of 30 s inflation/5 s deflation). Sessions were performed 3 days per week for 8 weeks. |
| Low-Load Training Group | Active comparator | Behavioral: Conventional Low-Load Resistance ExerciseOlder adults who performed the identical low-load upper-body resistance exercise protocol (4 exercises, 4x12 repetitions at 20-40% 1RM) 3 days per week for 8 weeks, but without wearing restriction cuffs. |
| Non-Exercise Control Grou | No intervention | –Older adults who maintained their habitual lifestyle and daily physical activities without participating in any structured resistance training program for 8 weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 50 years or older.
- Recreationally active, defined as participating in light-to-moderate physical activity 2 or more days per week.
- No structured resistance training within the preceding six months.
- Free from cardiovascular disease, neurological conditions, or musculoskeletal injury contraindicating resistance exercise.
- Able to provide written informed consent before enrollment.
Key exclusion criteria (3 listed)
- Current use of anticoagulant or vasoactive medication.
- History of deep vein thrombosis (DVT).
- Resting systolic blood pressure greater than 160 mmHg.
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 Restriction (BFR)Vascular restriction administered using an automated cyclical pneumatic device (KAATSU Cycle 2.0) with 40 mm cuffs placed proximally on both arms. Protocol consists of 8 cycles of 30 seconds of inflation followed by 5 seconds of deflation per cycle, individually calibrated by capillary refill time and verified by Doppler ultrasound. | Device | Cyclical Blood Flow Restriction (BFR) Group |
| Conventional Low-Load Resistance ExerciseUpper-body resistance exercise training encompassing four movements: biceps curl, triceps pushdown, lat pulldown, and chest press. Executed under a controlled 4x12 repetition scheme at an intensity of 20-40% 1RM, performed 3 days per week for a duration of 8 weeks. | Behavioural | Cyclical Blood Flow Restriction (BFR) Group, Low-Load Training Group |
Primary outcome
Nailfold Capillary Diameter
Time frame: Baseline and post-intervention (at the end of week 8)
Microvascular morphology changes measured at three anatomical regions: the arterial (afferent) limb, the apical portion, and the venous (efferent) limb using nailfold video capillaroscopy.
Upper-Arm Muscle Thickness
Time frame: Baseline and post-intervention (at the end of week 8).
Structural muscle hypertrophy of the biceps brachii and triceps brachii muscles of the dominant arm, assessed via B-mode ultrasonography.
3 secondary outcomes
Total Body Mass
Time frame: Baseline and post-intervention (at the end of week 8)
Body Fat Percentage
Time frame: Baseline and post-intervention (at the end of week 8)
Fat Mass
Time frame: Baseline and post-intervention (at the end of week 8)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared to protect participant privacy and confidentiality, in accordance with the institutional ethics committee approval. However, de-identified data may be made available to qualified researchers upon reasonable request directed to the corresponding author.
Related trials for Sarcopenia in Elderly
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
MF-300 for Treatment of Age-Related Sarcopenia
Sarcopenia in Elderly
RecruitingObservational study
Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer
Colorectal Cancer, Sarcopenia
Not yet recruiting
Eccentric Exercise in Community-dwelling Older Adults
Ageing Well
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 (BFR) and Conventional Low-Load Resistance Exercise in people with Sarcopenia in Elderly and Muscle Atrophy, run by Akdeniz University at 1 site in Turkey (Türkiye).
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 8 Jul 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nailfold Capillary Diameter (time frame: Baseline and post-intervention (at the end of week 8)). The study lists 2 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 8 Jul 2026.