Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000781044
Ethics application status
Approved
Date submitted
16/09/2010
Date registered
20/09/2010
Date last updated
20/09/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Chronic Disease Self-Management Program with or without supervised exercise for people with chronic obstructive pulmonary disease
Scientific title
A mixed methods study for people with chronic obstructive pulmonary disease on the effect of supervised exercise with the Chronic Disease Self-Management Program compared to the Chronic Disease Self-Management Program without supervised exercise on physical capacity.
Secondary ID [1] 252615 0
Not applicable
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 256820 0
Condition category
Condition code
Respiratory 256969 256969 0 0
Chronic obstructive pulmonary disease
Physical Medicine / Rehabilitation 256970 256970 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
(1) The intervention was supervised exercise added to the Chronic Disease Self-Management Program (CDSMP-Ex). See point two below for a description of the CDSMP.
Frequency - 1 session per week, held in the same week as the Chronic Disease Self-Management Program .
Intensity - the intensity of exercise was determined by using the modified Borg Rating of Perceived Exertion (RPE) Scale, aiming for a minimum of moderate intensity (RPE = 3) and not exceeding a strong intensity (RPE = 5).
Time (duration of exercise session) - 1 hour
Type - This general guideline was adjusted according to individual needs:
5 minutes of warm-up exercises
30 minutes of aerobic exercise (bicycle , treadmill, corridor walking, bicycle arm pedals)
5 minutes of stretching exercise (upper limb, lower limb, and trunk)
10 minutes of strengthening exercise (upper limb, lower limb, trunk with free weights, pulleys, steps, elastic bands, or fit ball)
5 minutes of cool-down exercises.
Mode - Participants attended in a group, with each individual progressing according to their response to exercise. Exercise sessions were supervised by a trained physiotherapy assistant, with the physiotherapist readily available for consultation if needed.

(2) The Chronic Disease Self-Management Program is a highly structured group-based 6-week workshop with sessions of 2½ hours duration offered once per week and facilitated by pairs of trained leaders.The leaders may be peers (others with a chronic condition) or health professionals who have undertaken 24 hours of training. It offers generic education about health-related behaviours: symptom management (anger, fear, frustration, depression, shortness of breath, fatigue, pain); breathing exercises; muscle relaxation; endurance exercise; cognitive symptom management; communication skills; advance directives for health care; working with and informing the healthcare team; medication usage and healthy eating. The CDSMP aims to facilitate the development of self-management self-efficacy (akin to confidence) through guided feedback sessions, problem-solving and completing action plans to achieve participant-defined goals. There is no supervised exercise component.
Intervention code [1] 256025 0
Rehabilitation
Intervention code [2] 256026 0
Behaviour
Intervention code [3] 257226 0
Treatment: Other
Comparator / control treatment
Chronic Disease Self-Management Program without supervised exercise (CDSMP-Only)
Control group
Active

Outcomes
Primary outcome [1] 257856 0
Physical capacity measured by the 6 minute walk test
Timepoint [1] 257856 0
One week pre and one week post attendance at the six week Chronic Disease Self-Management Program with or without supervised exercise
Secondary outcome [1] 263305 0
Self-reported exercise was measured with the Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire (Stewart et al. 2001)
Timepoint [1] 263305 0
One week pre and one week post attendance at the six week Chronic Disease Self-Management Program with or without supervised exercise
Secondary outcome [2] 263306 0
Self-efficacy for exercise was measured with the Exercise: Self-Efficacy scale (Cancer Prevention Research Center 1991)
Timepoint [2] 263306 0
One week pre and one week post attendance at the six week Chronic Disease Self-Management Program with or without supervised exercise
Secondary outcome [3] 263307 0
Exercise participation (achieving minimum reccommended levels of exercise) measured by a dichotomous question :
Do you exercise regularly according to the definition below? Y/N
Regular Exercise is any planned physical activity (e.g., brisk walking, aerobics, bicycling, swimming, line-dancing, tennis, doing formal exercises etc.) performed to increase or maintain health and physical fitness. Such exercise should be performed on all or at least 5 days of the week to accumulate 30 minutes or more per day. Exercise does not have to be painful to be effective but should be done at a moderate level that increases your breathing rate and makes you feel warmer.
Timepoint [3] 263307 0
One week pre and one week post attendance at the six week Chronic Disease Self-Management Program with or without supervised exercise
Secondary outcome [4] 263308 0
Stage of change for exercise was measured with the Exercise: Stages of Change Short Form questionnaire (Cancer Prevention Research Center 1991)
Timepoint [4] 263308 0
One week pre and one week post attendance at the six week Chronic Disease Self-Management Program with or without supervised exercise
Secondary outcome [5] 263309 0
Shortness of breath was measured with a Visual Analogue Scale (VAS) (American Thoracic Society 1999; Gift 1989; Nici et al. 2007)
Timepoint [5] 263309 0
One week pre and one week post attendance at the six week Chronic Disease Self-Management Program with or without supervised exercise
Secondary outcome [6] 263310 0
Self-management behaviours were measured with the Flinders University Partners in Health (PIH) Scale (Battersby et al. 2003)
Timepoint [6] 263310 0
One week pre and one week post attendance at the six week Chronic Disease Self-Management Program with or without supervised exercise
Secondary outcome [7] 263311 0
Health-related quality of life was measured with the Short Form- 36 version 2 Generic Health Survey (SF-36v2) (Ware, Kosinski & Dewey 2000)
Timepoint [7] 263311 0
One week pre and one week post attendance at the six week Chronic Disease Self-Management Program with or without supervised exercise

Eligibility
Key inclusion criteria
Participants were required to meet the following criteria:
be over 18 years;
willing to attend a supervised exercise component;
willing and able to commit to 8 weeks of attendance;
have a diagnosis of chronic obstructive pulmonary disease (COPD) based on airflow limitation measured by spirometry (McKenzie, Frith & Burdon 2003) or a physician diagnosis and be at least 2 months post exacerbation. An exacerbation was defined as increased shortness of breath, increased mucus production, and purulent mucus (Bellamy, Booker & Fardy 2003; MacNee & Rennard 2004)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants were ineligible if
they had an intellectual disability,
were unable to provide informed consent, were unable to complete a self-administered questionnaire,
had previously attended a Chronic Disease Self-Management Program (CDSMP) or a comprehensive cardiopulmonary rehabilitation programme, within the past two years or
were unable to safely undertake an exercise programme due to the presence of any one of the following conditions: uncontrolled cardiac conditions (resting systolic blood pressure > 180mm mercury and/or resting diastolic blood pressure > 110mm mercury, resting heart rate >120 beats per minute, unstable angina, severe cardiac valve disease, uncontrolled atrial or ventricular arrhythmias, uncompensated chronic heart failure, active pericarditis or myocarditis); recent vascular conditions (recent embolism or thrombophlebitis, active retinal haemorrhage, recent cerebrovascular accident); uncontrolled metabolic disorder (uncontrolled diabetes, retinopathy, acute thyroiditis, uncontrolled liver or renal disease, active cancer); severe orthopaedic problems; acute systemic illness or fever(Balady 2000).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Recruitment to the programme was by referral from general practitioners, specialist practitioners, or in-hospital referrals from medical practitioners, allied health or nursing staff.
Allocation concealment was by opaque sealed envelopes as described below.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The confines of the gym meant that the numbers randomised to the exercise intervention were confined to up to seven participants at a time. Therefore consecutive random numbers were used and the following process implemented.
If, during randomisation, the limit of seven was reached in one group, all other participants had to be allocated to the other group. The allocation was kept in separate opaque sealed envelopes until participants had completed the 6-minute walk test and pre-assessment questionnaires. Following this, a volunteer participant randomly selected one of the sealed envelopes, nominating CDSMP-EX or CDSMP-Only, similar to tossing a coin. In this way the two groups named in the envelopes were randomly allocated to the intervention or control groups. The investigator was blinded to the study allocation until participants were informed.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
78
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256526 0
University
Name [1] 256526 0
University of Tasmania
Country [1] 256526 0
Australia
Funding source category [2] 256527 0
Hospital
Name [2] 256527 0
Royal Hobart Hospital
Country [2] 256527 0
Australia
Primary sponsor type
University
Name
Menzies Research Institute
Address
17 Liverpool St
Hobart,
Tasmania. 7000
Country
Australia
Secondary sponsor category [1] 255869 0
University
Name [1] 255869 0
University of Tasmania, Faculty of Education
Address [1] 255869 0
Private Bag 66,
Hobart,
Tasmania. 7001
Country [1] 255869 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258609 0
Human Research Ethics Committee (Tasmania)
Ethics committee address [1] 258609 0
Ethics committee country [1] 258609 0
Australia
Date submitted for ethics approval [1] 258609 0
Approval date [1] 258609 0
15/12/2004
Ethics approval number [1] 258609 0
H0008105

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30848 0
Address 30848 0
Country 30848 0
Phone 30848 0
Fax 30848 0
Email 30848 0
Contact person for public queries
Name 14095 0
Helen Cameron-Tucker
Address 14095 0
Royal Hobart Hospital,
GPO Box 1061,
Hobart,
Tasmania. 7001
Country 14095 0
Australia
Phone 14095 0
61-3-6222 8634
Fax 14095 0
Email 14095 0
[email protected]
Contact person for scientific queries
Name 5023 0
Helen Cameron-Tucker
Address 5023 0
Royal Hobart Hospital,
GPO Box 1061,
Hobart,
Tasmania. 7001
Country 5023 0
Australia
Phone 5023 0
61-3-6222 8634
Fax 5023 0
Email 5023 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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