- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07694349
Moderate-Intensity Treadmill Walking With Blood Flow Restriction Improves Pulmonary Volumes in Older Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This quasi-experimental pilot study aimed to investigate whether a moderate-intensity treadmill walking program combined with blood flow restriction (BFR) could improve pulmonary function in trained older women. Fourteen physically active women (68.1 ± 3.6 years), free from major chronic diseases, were enrolled and allocated to either an intervention group (n = 7) or a control group (n = 7). The intervention group performed a modified Bruce treadmill protocol with BFR applied to both thighs at 30-40% of arterial occlusion pressure, whereas the control group completed the same training program without BFR. Both groups trained three times per week for 12 months, progressively advancing to stage 4 of the protocol.
Pulmonary function was assessed by spirometry every three months, measuring forced expiratory volume in one second (FEV₁) and forced vital capacity (FVC). The BFR group demonstrated significant improvements in FEV₁, increasing from approximately 2.26 L to 3.10 L, particularly during the first six months of the intervention, representing an improvement of nearly 41%. FVC also showed progressive increases; however, between-group differences did not reach statistical significance. The control group exhibited smaller and generally non-significant improvements.
The authors suggest that these benefits may be explained by mechanisms related to the metabolic stress induced by BFR, activation of the respiratory metaboreflex, and stimulation of anabolic signaling pathways such as Akt/mTOR, which may promote adaptations in the respiratory musculature. Additionally, hemodynamic parameters remained within safe ranges throughout the intervention, and no adverse events were reported, supporting the safety of the method.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Santiago, Chile, 8320000
- Clinica Oces
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Brazo experimental:
Aerobic treadmill training combined with blood flow restriction (30-40% of arterial occlusion pressure).
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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.
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Active Comparator: Brazo comparador/control:
Aerobic treadmill training without blood flow restriction.
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Participants completed the same modified Bruce treadmill walking program, matched for frequency and duration, without blood flow restriction.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Forced Expiratory Volume in One Second (FEV₁)
Time Frame: Baseline and 12 months (although quarterly assessments were performed, the primary analysis was based on pre- and post-intervention measurements).
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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.
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Baseline and 12 months (although quarterly assessments were performed, the primary analysis was based on pre- and post-intervention measurements).
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- No publications are currently available for this study protocol.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 196-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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