NCT07694349

Brief Summary

This quasi-experimental pilot study evaluated the effect of 12 months of moderate-intensity treadmill walking with blood flow restriction (BFR) on pulmonary function in 14 trained older women. Participants were allocated to either a BFR group (30-40% arterial occlusion pressure) or a control group without BFR. Both groups completed the same aerobic exercise program three times per week. The BFR group showed significant improvements in forced expiratory volume in one second (FEV₁) and forced vital capacity (FVC), along with a reduction in resting heart rate, with no adverse events reported. These findings suggest that BFR is a safe and promising strategy to optimize respiratory function in older adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

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

January 1, 2025

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2025

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2026

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 9, 2026

Completed
Last Updated

July 9, 2026

Status Verified

July 1, 2026

Enrollment Period

24 days

First QC Date

June 10, 2026

Last Update Submit

July 7, 2026

Conditions

Keywords

Physically trainedrehabilitationelderly peoplerespiratory sarcopenia

Outcome Measures

Primary Outcomes (1)

  • Change in Forced Expiratory Volume in One Second (FEV₁)

    Assessed by spirometry to determine changes in pulmonary function from baseline to 12 months of intervention. FEV₁ was expressed in liters (L) and compared between the blood flow restriction group and the control group.

    Baseline and 12 months (although quarterly assessments were performed, the primary analysis was based on pre- and post-intervention measurements).

Study Arms (2)

Brazo experimental:

EXPERIMENTAL

Aerobic treadmill training combined with blood flow restriction (30-40% of arterial occlusion pressure).

Device: Blood Flow Restriction

Brazo comparador/control:

ACTIVE COMPARATOR

Aerobic treadmill training without blood flow restriction.

Other: Aerobic training

Interventions

Blood flow restriction was applied using 108 × 10 cm pneumatic cuffs (BodyPro®, Kinemax®) positioned at the proximal region of both thighs, approximately three finger-widths below the gluteal fold. Occlusion pressure was set at 30-40% of each participant's arterial occlusion pressure, which was determined using sphygmomanometry and an 8-MHz vascular Doppler probe placed over the posterior tibial artery. Blood flow restriction was maintained continuously throughout the treadmill walking sessions based on the modified Bruce protocol. The intervention lasted 12 months and was performed three times per week.

Brazo experimental:

Participants completed the same modified Bruce treadmill walking program, matched for frequency and duration, without blood flow restriction.

Brazo comparador/control:

Eligibility Criteria

Age60 Years - 80 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsthe target population was to compare only women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women aged 60 to 80 years without a diagnosis of chronic non-communicable diseases.
  • Physically active individuals.
  • At least 3 consecutive months of participation in structured exercise programs.
  • Weekly physical activity volume ≥ 180 minutes, assessed using the Global Physical Activity Questionnaire (GPAQ).

You may not qualify if:

  • Use of ergogenic aids.
  • Current smoking habit.
  • Diagnosis of cardiometabolic diseases.
  • Presence of neurological disorders or musculoskeletal impairments affecting the lower extremities.
  • Peripheral vascular diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Oces

Santiago, 8320000, Chile

Location

Related Publications (1)

  • No publications are currently available for this study protocol.

    RESULT

MeSH Terms

Interventions

Blood Flow Restriction Therapy

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist Researcher

Study Record Dates

First Submitted

June 10, 2026

First Posted

July 9, 2026

Study Start

January 1, 2025

Primary Completion

January 25, 2025

Study Completion

March 2, 2026

Last Updated

July 9, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

All individual participant data (IPD) underlying a publication.

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations