- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07805330
Effects of Blood Flow Restriction Rehabilitation on Functional Mobility and Balance Among Chronic Obstructive Pulmonary Disease Patients.
Effects of Blood Flow Restriction Rehabilitation on Functional Mobility and Balance Among Chronic Obstructive Pulmonary Disease Patients
Background: Chronic obstructive pulmonary disease (COPD) is a common lung disease causing restricted airflow and breathing problems. It is sometimes called emphysema or chronic bronchitis. The damage results in swelling and irritation, also called inflammation, inside the airways that limit airflow into and out of the lungs. BFR Rehabilitation is effective in improving functional mobility and balance among COPD patients.
Objective: To find out the effects of Blood Flow Restriction (BFR) Rehabilitation on functional mobility and balance among COPD (Chronic Obstructive Pulmonary Disease) patients.
Methods: A Randomized Controlled Trial Study was conducted at Gulab Devi Hospital, Hameed Latif Hospital and Arif Memorial Teaching Hospital Lahore. Fifty patients of age 45-60 years with COPD were randomized into two groups. Allocation of patients in two equal groups by lottery method will be through random assignment. Group A was treated with controlled physical therapy while Group B was treated with BFR rehabilitation. Controlled treatment includes low intensity resistance exercises while BFR Rehabilitation includes use of a tourniquet with low intensity resistance exercises. All this information will be collected through a pulse oximeter. Berg Balance Scale will be used for balance and timed up and go test for functional mobility.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Aleena Waheed, Masters in Physical Therapy
- Numéro de téléphone: 03214883868
- E-mail: alwaheed28@gmail.com
Lieux d'étude
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Lahore, Pakistan, 54900
- Recrutement
- Arif Memorial Teaching Hospital
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Contact:
- Aleena Waheed
- Numéro de téléphone: 03214883868
- E-mail: alwaheed28@gmail.com
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Chercheur principal:
- Harmeen Nadeem, Doctor of Physical Therapy
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Subjects who are clinically stable before study
- Forced expiratory volume in 1s (FEV1)/forced vital capacity (FVC)<70% and FEV1 ≥30% but <80% respectively
- Subjects who will be willing to take part in this study
Exclusion Criteria:
- Upper abdominal surgery
- Lung cancer
- Open fracture
- Mental disorder
- Active malignancy
- Severe hypertension
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Resistance Exercise without tourniquet
The control group performed the same above-mentioned resistance training without the pressure cuff under the supervision of physiotherapist.
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The control group performed the same above-mentioned resistance training without the pressure cuff under the supervision of physiotherapist.
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Expérimental: Blood flow restriction resistance exercise
Blood flow restriction resistance exercise (BFR-RE), or Kaatsu training, was developed by Dr. Yoshiaki Sato over 40 years ago.
It uses a low load (15-30% 1-RM) to induce gains in muscle strength and mass.
External pressure (~80% limb occlusion pressure, LOP) is applied via a tourniquet cuff to the proximal limb, restricting venous return while allowing partial arterial inflow, creating blood pooling in distal muscles.
Training was supervised by BFR-certified physiotherapists using medium-sized cuffs, placed at the proximal thigh for a maximum of 10 minutes.
Pressure was auto-adjusted to personalized LOP, inflated before the first set, maintained during rests, and deflated post-session.
Each session trained a single limb, alternated on different days, 2-3 times/week.
Exercises included isotonic knee extensions from 150° to 180°: 1 set of 30 reps, then 3 sets of 15 reps, with 30-second rests, at 1-2 sec/repetition, using sandbag resistance (15-30% 1-RM).
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Blood flow restriction resistance exercise (BFR-RE), or Kaatsu training, was developed by Dr. Yoshiaki Sato over 40 years ago.
It uses a low load (15-30% 1-RM) to induce gains in muscle strength and mass.
External pressure (~80% limb occlusion pressure, LOP) is applied via a tourniquet cuff to the proximal limb, restricting venous return while allowing partial arterial inflow, creating blood pooling in distal muscles.
Training was supervised by BFR-certified physiotherapists using medium-sized cuffs, placed at the proximal thigh for a maximum of 10 minutes.
Pressure was auto-adjusted to personalized LOP, inflated before the first set, maintained during rests, and deflated post-session.
Each session trained a single limb, alternated on different days, 2-3 times/week.
Exercises included isotonic knee extensions from 150° to 180°: 1 set of 30 reps, then 3 sets of 15 reps, with 30-second rests, at 1-2 sec/repetition, using sandbag resistance (15-30% 1-RM).
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Balance
Délai: Pre intervention and 4 weeks post intervention
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Balance was assessed using the Berg Balance Scale (BBS), a widely used clinical tool that evaluated functional balance through 14 tasks of varying difficulty.
Each task was scored from 0-4, with a maximum score of 56.
Higher scores indicated better balance, while lower scores reflected greater fall risk.
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Pre intervention and 4 weeks post intervention
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Oxygen Saturation
Délai: Pre intervention and 4 weeks post intervention
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Oxygen saturation reflects the percentage of haemoglobin carrying oxygen, normally ranging between 95-100% in healthy individuals.
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Pre intervention and 4 weeks post intervention
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Respiratory rate
Délai: Pre-intervention and 4 weeks post-intervention
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Respiratory rate will be measured using a pulse oximeter and recorded as the number of breaths taken per minute.
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Pre-intervention and 4 weeks post-intervention
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Heart Rate
Délai: Pre-intervention and 4 weeks post-intervention
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Heart rate will be measured using a pulse oximeter and recorded as the number of heartbeats per minute.
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Pre-intervention and 4 weeks post-intervention
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Harmeen Nadeem, Arif Memorial Teaching Hospital
Publications et liens utiles
Publications générales
- Kohlbrenner D, Kuhn M, Manettas A, Aregger C, Peterer M, Greco N, Sievi NA, Clarenbach C. Low-load blood flow restriction strength training in patients with COPD: a randomised single-blind pilot study. Thorax. 2024 Mar 15;79(4):340-348. doi: 10.1136/thorax-2023-220546.
- Lamberti N, Straudi S, Donadi M, Tanaka H, Basaglia N, Manfredini F. Effectiveness of blood flow-restricted slow walking on mobility in severe multiple sclerosis: A pilot randomized trial. Scand J Med Sci Sports. 2020 Oct;30(10):1999-2009. doi: 10.1111/sms.13764. Epub 2020 Jul 25.
- Clarkson MJ, May AK, Warmington SA. Chronic Blood Flow Restriction Exercise Improves Objective Physical Function: A Systematic Review. Front Physiol. 2019 Aug 21;10:1058. doi: 10.3389/fphys.2019.01058. eCollection 2019.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB/2024/209
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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