The Effect of Body Awareness Therapy on Postural Stability, Balance and Fear of Falling in Patients With COPD

NCT04212676 | Unknown

• 1 other identifier: 09.2019.1031
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Asthma; Body Awareness Treatment; Postural Stability; Balance; Fear of Falling

Outcome Measures

Primary Outcomes (3)

• Postural Stability

  In our study, the postural stability levels of the cases will be evaluated with their feet wide open on the balance platform without any support. The subjects were asked to hold the ball at the midpoint of the circle on the screen opposite to the position and center of gravity of the individual and to keep it at the midpoint for 1 minute; During the measurement, right - left and anterior - posterior oscillations and overall performance levels of the subjects will be recorded.

  8 weeks

• Balance

  Balance Master device will be used. Using a fixed 18 "x 60" force platform, the Balance Master determines the vertical force exerted by the patient's feet to measure the center of balance.

  8 weeks

• Fear of Falling

  It will be evaluated by the Drop Efficacy Scale. ISI is a 10-item scale. They are asked to score between 1 and 10 to the questions. 1 means a lot of trust, 10 means no. A total score of 0 to 100 is obtained. If the total score is more than 70 points, there is fear of falling.

  8 weeks

Secondary Outcomes (5)

• Tiffeneau index for Pulmonary Function Test

  8 weeks

• The Medical Research Council Dyspnea Scale (mMRC) for dyspnea

  8 weeks

• 6-Minute Walk Test (6MWT) for functional capacity

  8 weeks

• Chronic Obstructive Pulmonary Disease Assessment Test (CAT)

  8 weeks

• Self-Efficacy Scale for the assessment of disease compliance:

  8 weeks

Study Arms (2)

PR+BAT Group

EXPERIMENTAL

In addition to the PR program, the BAT will be administered to the experimental group by a physiotherapist with 5 years of experience in BAT for 8 weeks.

Other: Body Awareness Therapy; Other: Pulmonary Rehabilitation

PR Group

ACTIVE COMPARATOR

Patients in the control groups will receive a 30-minute Pulmonary Rehabilitation (PR) program every day of the week for 8 weeks.

Other: Pulmonary Rehabilitation

Interventions

Body Awareness Therapy OTHER

The BAT for the participants was based on the works of Roxendal and Dropsy. Activities include relaxation exercises, breathing exercises, floor exercises for trunk and pelvic movements, weight transfer using extremities and proprioceptive movements. Movements will be made in various positions to determine the centerline of the body. All exercises will be started in the supine position to maximize proprioceptive motion feedback and minimize energy requirements during tasks. Movements will be taught in a series of lessons over a period of 8 weeks with advance advancement of selected movements depending on participant comfort.

Also known as: BAT

PR+BAT Group

Pulmonary Rehabilitation OTHER

Diaphragmatic breathing exercise Thoracic expansion exercises (Chest breathing and bilateral segmental breathing exercises) Inductive spirometry (Triflo®) exercise Cough development techniques

Also known as: PR

PR Group; PR+BAT Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, 34000, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Karaca S, Yildiz Ozer A, Karakurt S, Polat MG. Effects of body awareness therapy on balance and fear of falling in patients with chronic obstructive pulmonary disease: a randomized controlled trial. Biopsychosoc Med. 2024 Feb 26;18(1):6. doi: 10.1186/s13030-024-00303-x.

  PMID: 38409129 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Seda Karaca, MsC

  Marmara University

  PRINCIPAL INVESTIGATOR

• Aysel Yıldız Özer, Ass.Prof.Dr.

  Marmara University

  STUDY CHAIR

• Sait Karakurt, Prof. Dr.

  Marmara University

  STUDY DIRECTOR

Central Study Contacts

Seda Karaca

CONTACT

00905077743857; aisa.sed@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 27, 2019
• Study Start: February 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2022
• Last Updated: December 27, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)