- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание 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.
Обзор исследования
Статус
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Aleena Waheed, Masters in Physical Therapy
- Номер телефона: 03214883868
- Электронная почта: alwaheed28@gmail.com
Места учебы
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Lahore, Пакистан, 54900
- Рекрутинг
- Arif Memorial Teaching Hospital
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Контакт:
- Aleena Waheed
- Номер телефона: 03214883868
- Электронная почта: alwaheed28@gmail.com
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Главный следователь:
- Harmeen Nadeem, Doctor of Physical Therapy
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Активный компаратор: 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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Экспериментальный: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Balance
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Harmeen Nadeem, Arif Memorial Teaching Hospital
Публикации и полезные ссылки
Общие публикации
- 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.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- IRB/2024/209
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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