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Completed

NCT Number: NCT07694349

Moderate-Intensity Treadmill Walking With Blood Flow Restriction Improves Pulmonary Volumes in Older Adults

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.

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Key information

Conditions

Age range

60 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Oces

Santiago, 8320000, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood Flow Restriction

Device

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 training

Other

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Universidad Santo Tomas, Chile

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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