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Trial registered on ANZCTR

Registration number

ACTRN12614000778684

Ethics application status

Approved

Date submitted

12/07/2014

Date registered

21/07/2014

Date last updated

21/07/2014

Type of registration

Retrospectively registered

Titles & IDs

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.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic Obstructive Pulmonary Disease

Quality of life

Fatigue

Depression

Anxiety

Condition category

Condition code

Respiratory

Chronic obstructive pulmonary disease

Physical Medicine / Rehabilitation

Physiotherapy

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Rehabilitation

Comparator / control treatment

Patients assigned to the control group receive only the usual Pulmonary Rehabilitation program.
it involves setting the intensity of eff ort on a target heart
rate corresponding to 60 -70% of maximum heart rate
reached during the 6-minute walking test. Th is intensity
of training does not lead to excessive symptoms of dyspnea
and fatigue. During the sessions, the subject can
monitor the intensity of training by means of a cardiofrequency
meter (Polar, S810) where alarms are set to
± 5 beats per minute around the target heart rate.
Th e training consists of a 5-minute warm-up followed
by 10 minutes of work (cycling or walking on a
treadmill) and 5 minutes of active recovery, repeated
over a 45-minute session. Th en, the subjects performed
strength exercises (legs and arms) for 30 minutes; the
resistance training included 3 sets per session of each
of the following: seated leg press, seated leg curl, seated
leg extension, standing calf raise, and seated ankle dorsifl
exion. Training intensity was set at 60% of the pretraining
one-repetition maximum for the fi rst 4 weeks
and increased as tolerated thereafter to 80% of the new
one-repetition maximum obtained after 4 weeks of
training, for each exercise. Finally, the session ends with
relaxation exercises and stretching.

Control group

Active

Outcomes

Primary outcome [1]

Fatigue was assessed using the Multidimensional Fatigue Inventory (MFI-20)

Timepoint [1]