- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Aleena Waheed, Masters in Physical Therapy
- Telefonnummer: 03214883868
- E-post: alwaheed28@gmail.com
Studieorter
-
-
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Lahore, Pakistan, 54900
- Rekrytering
- Arif Memorial Teaching Hospital
-
Kontakt:
- Aleena Waheed
- Telefonnummer: 03214883868
- E-post: alwaheed28@gmail.com
-
Huvudutredare:
- Harmeen Nadeem, Doctor of Physical Therapy
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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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Experimentell: 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).
|
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).
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Balance
Tidsram: Pre intervention and 4 weeks post intervention
|
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
Tidsram: Pre intervention and 4 weeks post intervention
|
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
Tidsram: Pre-intervention and 4 weeks post-intervention
|
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
Tidsram: Pre-intervention and 4 weeks post-intervention
|
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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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Harmeen Nadeem, Arif Memorial Teaching Hospital
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB/2024/209
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