Older WomenNCT07694349
Moderate-Intensity Treadmill Walking With Blood Flow Restriction Improves Pulmonary Volumes in Older Adults
A study testing Blood Flow Restriction and Aerobic training in people with Older Women, run by Universidad Santo Tomas, Chile at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Older Women
- What is being tested?
- Blood Flow Restriction and Aerobic training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChile
- Study dates
- 1 Jan 2025to 2 Mar 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 60 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Older Women
- Being tested
- Blood Flow Restriction, Aerobic training
- Keywords
- Physically trained, rehabilitation, elderly people, respiratory sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow RestrictionDevice
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.
Aerobic trainingOther
Participants completed the same modified Bruce treadmill walking program, matched for frequency and duration, without blood flow restriction.
| Study group | Role | What they receive |
|---|---|---|
| Brazo experimental: | Experimental | Aerobic treadmill training combined with blood flow restriction (30-40% of arterial occlusion pressure). Receives: Device: Blood Flow Restriction |
| Brazo comparador/control: | Active comparator | Aerobic treadmill training without blood flow restriction. Receives: Other: Aerobic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 months (although quarterly assessments were performed, the primary analysis was based on pre- and post-intervention measurements).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Jan 2025
- Primary completion25 Jan 2025
- Study completion2 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Older WomenStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Santo Tomas, Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastian Norambuena Meza, Universidad Santo Tomas, Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694349
- Sponsor's protocol ID
- 196-2025
- Status last verified
- Jul 2026
- First submitted
- 10 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (IPD) underlying a publication.
Publications
No publications are currently available for this study protocol.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moderate-Intensity Treadmill Walking With Blood Flow Restriction Improves Pulmonary Volumes in Older Adults
- ClinicalTrials.gov ID
- NCT07694349
- Acronym / sponsor ID
- 196-2025
- Conditions
- Older Women
- Keywords
- Physically trained, rehabilitation, elderly people, respiratory sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Universidad Santo Tomas, ChileUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 25 Jan 2025 (actual)
- Study completion
- 2 Mar 2026 (actual)
- First posted
- 9 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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brazo experimental: | Experimental | Device: Blood Flow RestrictionAerobic treadmill training combined with blood flow restriction (30-40% of arterial occlusion pressure). |
| Brazo comparador/control: | Active comparator | Other: Aerobic trainingAerobic treadmill training without blood flow restriction. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
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 RestrictionBlood 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. | Device | Brazo experimental: |
| Aerobic trainingParticipants completed the same modified Bruce treadmill walking program, matched for frequency and duration, without blood flow restriction. | Other | Brazo comparador/control: |
Primary outcome
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).
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.
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 9 Jul 2026.
- Results publicationNo publications are currently available for this study protocol.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD) underlying a publication.
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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. 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 and Aerobic training in people with Older Women, run by Universidad Santo Tomas, Chile at 1 site in Chile.
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 4 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: finished, as of the sponsor's last update on 9 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 Chile. 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?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07694349, which also lists 1 linked publication.
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 9 Jul 2026.