NCT07689487

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2026

Completed
Last Updated

July 8, 2026

Status Verified

July 1, 2026

Enrollment Period

3 months

First QC Date

July 1, 2026

Last Update Submit

July 7, 2026

Conditions

Keywords

blood flow restrictionagingnailfold capillaroscopymuscle hypertrophyangiogenesissarcopeniaKAATSU

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline and post-intervention (at the end of week 8).

Secondary Outcomes (3)

  • Total Body Mass

    Baseline and post-intervention (at the end of week 8)

  • Body Fat Percentage

    Baseline and post-intervention (at the end of week 8)

  • Fat Mass

    Baseline and post-intervention (at the end of week 8)

Study Arms (3)

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.

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.

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.

Interventions

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.

Cyclical Blood Flow Restriction (BFR) Group

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.

Cyclical Blood Flow Restriction (BFR) GroupLow-Load Training Group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Current use of anticoagulant or vasoactive medication.
  • History of deep vein thrombosis (DVT).
  • Resting systolic blood pressure greater than 160 mmHg.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University, Faculty of Sport Sciences

Antalya, Antalya, 07058, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Muscular AtrophySarcopenia

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

July 1, 2026

First Posted

July 8, 2026

Study Start

February 1, 2026

Primary Completion

May 1, 2026

Study Completion

June 1, 2026

Last Updated

July 8, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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.

Locations