Effect of balance training enrolled in pulmonary rehabilitation on quality of life, fatigue perception, depression and anxiety in COPD patients.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614000778684
• Date of registration: 21/07/2014
• Prospective Registration: No
• Primary sponsor: Farhat Hached Hospital
• Public title: Effect of balance training enrolled in pulmonary rehabilitation on quality of life, fatigue perception, depression and anxiety in COPD patients.
• Scientific title: COPD patients and balance training: effect on quality of life, fatigue, depression and anxiety.
• Date of first enrolment: 14/07/2014
• Target sample size: 62
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12614000778684.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial;

Countries of recruitment

Tunisia

Contacts

• Name: Dr Wajdi Mkacher

• Name: Dr Wajdi Mkacher

Key inclusion & exclusion criteria

Inclusion criteria: (1) COPD diagnosed by pulmonary function, (2) stable clinical condition (3), absence of other obstructive disease (asthma, bronchiectasis...) and (4) lack of recent cardiac or neuromuscular pathologies.
Exclusion criteria: Individuals who smoke and those who run significant response to bronchodilators, defined as an increase in FEV1 over 12% from predicted values were excluded from our study

Age minimum: 45 Years
Age maximum: 70 Years
Gender: Males

Health Condition(s) or Problem(s) studied

Chronic Obstructive Pulmonary Disease ;Quality of life;Fatigue;Depression;Anxiety;
Chronic Obstructive Pulmonary Disease
Quality of life
Fatigue
Depression
Anxiety

Respiratory - Chronic obstructive pulmonary disease

Physical Medicine / Rehabilitation - Physiotherapy

Intervention(s)

Patients assigned to the intervention group undergo balance training three times a week for 24 weeks (72 sessions). Training sessions last 30 min and are monitored by health professionals. Participants receive individualized exercises and attention regarding the level of difficulty and approach to training progression. The content of the balance-training program was developed according to previous works , guidelines for fall prevention , and consultation with experts. Balance training consisted of four main types of exercise: (1) stance exercises, (2) transition exercises, (3) gait exercises, and (4) functional strengthening. When a participant was able to complete a task independently and with little instability, the difficulty level was increased progressively by introducing more challenging conditions (eg, eyes closed, addition of a secondary cognitive task, increased speed/repetition, or perturbations). Prior to beginning study, we pilot tested the training program on two patients with COPD to determine (1) equipment needs for safety and (2) feasibility of the balance program with respect to a 30-min session.
Balance training occurred concurrently with inpatient PR, which included (1) supervised exercise training bid three times a week, (2) daily breathing exercises, and (3) self-management education and psychologic and social support. Three times a week, patients in the intervention group receive the balance-training program in place of their usual morning or afternoon exercise session. Therefore, the total time spent exercising is matched between groups.

Primary Outcome(s)

Anxiety and depression were measured using the Hospital Anxiety and Depression Scale (HADS)[at baseline and at the end of the 6 months training program]

Fatigue was assessed using the Multidimensional Fatigue Inventory (MFI-20)[at baseline and at the end of the 6 months training program]

the quality of life was determined using the St. George's Respiratory Questionnaire (SGRQ) in its French version[at baseline and at the end of the 6 months training program]

Secondary Outcome(s)

exersise tolerance using the six minutes walk test[at baseline and at the end of the 6 months training program]

Pulmonary Function using a constant volume plethysmograph (ZAN 500 Body II MeBgrerate ZAN GmbH, Germany)[at baseline and at the end of the 6 months training program]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

University of SOUSSE

Secondary Sponsor(s)

Pr. TABKA Zouhair

Ethics review

Status: Approved
Approval date:
Contact:

Research Ethics Committee