- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07694349
Moderate-Intensity Treadmill Walking With Blood Flow Restriction Improves Pulmonary Volumes in Older Adults
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Santiago, Chile, 8320000
- Clinica Oces
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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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Aktiv komparator: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change in Forced Expiratory Volume in One Second (FEV₁)
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- No publications are currently available for this study protocol.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 196-2025
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Blood Flow Restriction
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The Methodist Hospital Research InstituteRekrutteringSund og rask | Sunde frivillige | Sunde mandlige og kvindelige emnerForenede Stater
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University of the Balearic IslandsAfsluttetBlodtryk | ModstandstræningSpanien
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Mayo ClinicAfsluttet
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Lauren EricksonAmerican College of Sports MedicineAfsluttetPatellofemoralt syndromForenede Stater
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The Hong Kong Polytechnic UniversityIkke rekrutterer endnuSarkopeni | Patienter med kronisk slagtilfældeHong Kong
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Paulista UniversityAfsluttet
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University of LjubljanaUniversity of Primorska; University Medical Centre LjubljanaAfsluttetKnæskader | Knækirurgi | Arthrogen muskelhæmningSlovenien
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Udayana UniversityAfsluttetSunde emner | Sport niveau 1Indonesien
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AspetarRekrutteringPatellofemoralt smertesyndrom | Kronisk knæsmerter | Rotator cuff tendinose | Rotator Cuff Impingement Syndrome | Anterior knæsmerter syndromQatar
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University of West AtticaIkke rekrutterer endnu