Clinical trial NCT04212676: The Effect of Body Awareness Therapy on Postural Stability, Balance and Fear of Falling in Patients With COPD
Official title: The Effect of Body Awareness Therapy on Postural Stability, Balance and Fear of Falling in Patients With COPD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Keywords: Asthma
Body Awareness Treatment
Postural Stability
Balance
Fear of Falling
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2019-12-27
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The type of study is experimental. A computer-based randomization program (random.org) will be used to identify patients to be assigned to the experimental and control groups. All patients in the experimental and control groups will receive a 30-minute Pulmonary Rehabilitation (PR) program every day of the week for 8 weeks. In addition to the PR program, the BAQ will be administered to the experimental group by the physiotherapist. At the end of the eight weeks, all initial assessments will be repeated. All patients will be supervised physiotherapy sessions for 8 weeks and checked how they implement the program.
Primary purpose: TREATMENT

Brief summary: Chronic obstructive pulmonary disease (COPD) is one of the serious diseases with a high prevalence and mortality, which adversely affects the quality of life, and is expected to rank third in the global burden of disease in 2020. Although the primary pathophysiology of the disease is pulmonary, it is emphasized that extrapulmonary involvement and comorbid conditions adversely affect the severity and prognosis of the disease. In the treatment guidelines for COPD, extrapulmonary systems and symptoms should also be evaluated. In this context, the number of studies on the effects of postural stability, balance and fall has increased recently, especially in COPD patients. Although the efficacy of pulmonary rehabilitation (PR) in COPD is well defined, it provides minimal gains in postural control and balance. Alternative therapies are needed to improve postural stability, balance and fall in COPD patients.

Body Awareness Therapy (BAQ) is an alternative method developed by French exercise instructor and psychotherapist Jacques Dropsy in the early 1970s following the emergence of the concept of body awareness, adapted to rehabilitation programs by Swedish and Norwegian physiotherapists. Traditional physiotherapy methods are the basis of BAQ. In the treatment, sensory stimulation and movement quality, rhythm, coordination, breathing, relaxation, balance, coordination and proprioceptive exercises give more space. In the literature, BAQ decreases pain, fatigue, eating and sleep problems in chronic musculoskeletal or rheumatic pain, coronary artery disease and neurological patient groups. It is seen to increase the quality of exercise, coordination, balance, postural control, quality of life and the integration between mind-body. Movement awareness and mind-body-behavior interaction developed in BAQ can help regulate emotional, mental, social and behavioral factors that affect health. In addition to improving coping skills and cognitive behaviors among COPD patients, it can contribute to positive gains in better movement, respiratory control and balance. The aim of this study is to investigate the effect of BAQ, which is integrated into 8-week pulmonary rehabilitation sessions, on postural stability, balance and fall conditions.

Detailed description: Chronic Obstructive Pulmonary Disease (COPD) is a common disease that can be prevented and treated, usually characterized by persistent respiratory symptoms and airway restriction due to airway and / or alveolar abnormalities due to exposure to harmful particles or gases. At the same time, it was emphasized that COPD is a systemic disease according to GOLD (Global Initiative for Obstructive Lung Diseases) and extrapulmonary involvement and comorbid conditions adversely affect the severity and prognosis of the disease. COPD is a chronic condition in which physical function, social function and general health are severely affected. Treatment in COPD is mainly aimed at effective disease management, prevention of disease progression, improvement of symptoms, and improvement of exercise tolerance. In the treatment guidelines for chronic lung diseases, extrapulmonary systems and symptoms should also be evaluated. In this context, the number of studies on the effects of postural stability, balance and fall has increased recently, especially in COPD patients. It is reported that the ability of the trunk to participate in postural stability due to increased resting breathing load, weakness of the muscle strength of the diaphragm, one of the major muscles with significant impact on balance, weakness of peripheral muscle and systemic inflammation lead to postural stability and balance risk in COPD patients. Clinical investigations of COPD patients in proportion to the severity of the disease; functional balance, coordination and mobility. Postural stability is defined as the act of maintaining, obtaining or recovering an equilibrium state during any posture or activity. Loss of postural control is one of the most common comorbidities in elderly individuals. Impaired postural control is more common when the elderly person has a chronic disease. The PLATINO study showed an increased prevalence of COPD in elderly individuals. Factors such as lower extremity muscle weakness, functional performance deficit and adaptive capacity, and reduced physical activity level in the elderly with COPD affect postural stability. In individuals with COPD, responses to postural perturbations have been shown to decrease compared to healthy controls. However, the ability to produce a successful postural reaction depends not only on motor performance but also on the efficient use of proprioceptive inputs. In a comprehensive study characterizing proprioceptive postural control in COPD, patients concluded that postural stabilization was impaired compared to healthy controls using ankle muscle proprioceptive signals more and back muscle proprioceptive signals less during balance control. These findings may be a potential risk factor for the likelihood of falls in COPD patients. Among the problems associated with COPD, there is considerable evidence that the risk of falls in these individuals increases. Falling problems and COPD are two major problems that bring great costs to the health system and especially affect elderly people. The well-known fall risk factors in COPD patients are lower limb muscle weakness and loss of mobility, characterized by a decrease in daily living activities. Although the efficacy of pulmonary rehabilitation (PR) in COPD is well defined, it provides minimal gains in postural control and balance. Alternative treatments are needed to improve balance and fall in COPD patients.

Body Awareness Therapy (BAT) is an alternative method developed by French exercise instructor and psychotherapist Jacques Dropsy in the early 1970s following the emergence of the concept of body awareness and adapted to rehabilitation programs by Swedish and Norwegian physiotherapists. Traditional physiotherapy methods are the basis of BAT. Focusing on the senses, proprioceptive exercises aiming to improve the quality of movement, rhythm and coordination with sensory stimuli. BAT treats the individual physically, physiologically, psychologically and socially with a holistic approach and the treatment program is shaped according to the patient's needs. Breathing exercises, relaxation exercises, movement approaches specific to sensory awareness, positioning, stabilization, improving rhythm and coordination, and improving the ability to perform the exercise with maximum awareness are used in physiotherapy methods used in BAT. It consists of specific exercises, which include focusing on how the body is used during movements, aiming at improving one's awareness, ability to be careful, and quality of movement. In the literature, it is seen that Body Awareness Therapy reduces pain, fatigue, eating and sleep problems in various patient groups and increases the quality, coordination, balance, postural control, quality of life and mind-body integration of the exercise.

VFT has been gaining popularity in recent years among many health professionals, especially physiotherapists. In BAT, movement is expressed by how one copes with the balance of the person and associates himself / herself with the place and vertical axis in relation to the environment. The integrity of postural stability is essential for comfortable breathing and awareness, key points for dynamic balance, and quality of movement. Although VFT consists of simple repetitive movements that maintain the ability to use stability limits, its main component is to increase the individual's awareness of his / her movements. Thanks to the neuroplasticity of the brain; multiple slow repetitive movements allow the participant to experience the body and its limits. Movement consciousness that develops by cortical processing of information about movement in the brain and facilitation of proprioceptive; postural control improves balance and coordination. In many cases that require treatment as a principled movement training technique behind mind-body interaction, which emphasizes motion teaching based on sensory motor awareness and cognitive perception of movement. BAT aims to normalize posture, balance, muscular tension and stiffness. Experiences learned by patients help them divide difficult movements into simpler, lighter movements with less energy consumption. Movement awareness and mind-body interaction during movement therapy can help regulate emotional, mental, social and behavioral factors that affect health. In addition to improving coping skills and cognitive behaviors among COPD patients, investigators think that integrating them into pulmonary rehabilitation sessions can have positive effects on postural stability, balance and fall, as they can help them move better and help postural control and thus improve their ability to perform daily living activities.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of COPD according to GOLD and willingness to participate
* Age between 40-80 years
* Clinically stable period
* No serious hearing and vision problems

Exclusion Criteria:

* Patients with recurrent exacerbations reported (history of exacerbation in the last two months)
* Having cognitive impairment (less than 24 Mini Mental Test scores)
* Having diagnosed vision, hearing, vestibular or neurological problems that may affect balance
* Having diagnosed orthopedic problems affecting mobility or having a history of surgical intervention
* COPD patients receiving home oxygen therapy or frequent need of oxygen therapy
* Patients with exercise-induced dyspnea
* Patients with primary pulmonary hypertension or patients with pulmonary embolism
* Congestive heart failure and severe coronary patients with coronary artery disease or by-pass surgery due to coronary artery disease
* Patients with morbid obesity
* Presence of systemic disease involving the lung and lung that would previously cause dyspnea other than COPD
* Having received pulmonary rehabilitation in the last 12 months
* Presence of unstable cardiovascular disease
* SpO2\<90%
* Problems with understanding and co-operation in understanding tests

Primary outcomes:
measure: Postural Stability
timeFrame: 8 weeks
measure: Balance
timeFrame: 8 weeks
measure: Fear of Falling
timeFrame: 8 weeks
Secondary outcomes:
measure: Tiffeneau index for Pulmonary Function Test
timeFrame: 8 weeks
measure: The Medical Research Council Dyspnea Scale (mMRC) for dyspnea
timeFrame: 8 weeks
measure: 6-Minute Walk Test (6MWT) for functional capacity
timeFrame: 8 weeks
measure: Chronic Obstructive Pulmonary Disease Assessment Test (CAT)
timeFrame: 8 weeks
measure: Self-Efficacy Scale for the assessment of disease compliance:
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
affiliation: Marmara University
name: Seda Karaca, MsC
role: PRINCIPAL_INVESTIGATOR
affiliation: Marmara University
name: Aysel Yıldız Özer, Ass.Prof.Dr.
role: STUDY_CHAIR
affiliation: Marmara University
name: Sait Karakurt, Prof. Dr.
role: STUDY_DIRECTOR
References: