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Early pulmonary rehabilitation in people with mild Chronic Obstructive Pulmonary Disease (COPD)

Early pulmonary rehabilitation in people with mild Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000965404
Acronym
EPR (Early Pulmonary Rehabilitation)
Enrollment
58
Registered
2016-07-22
Start date
2015-06-01
Completion date
2017-03-15
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Chronic obstructive pulmonary disease (COPD) is characterised by chronic inflammation of the airways and obstruction to airflow in the lungs, resulting in dyspnoea, chronic cough, and sputum production. The GOLD guidelines define mild COPD as a post-bronchodilator forced expiratory volume in 1 second (FEV1) to forced vital capacity ratio less than 0.7 and an FEV1 greater than of equal to 80% predicted. With COPD being a progressive and irreversible disease, disease management in the earlier stages is of great importance in order to optimise long term outcomes. People with mild COPD already have dynamic hyperinflation, impaired gas exchange and increased dead space ventilation which are associated with exercise limitation and fatigue. Also, a reduction in physical activity levels develops early in COPD, even before patients are diagnosed with the disease. According to a study exploring physical inactivity in patients with COPD, people with mild COPD were found to have 13% reduction in step counts and 47% reduction in time spent in moderate physical activity compared to healthy subjects. This is significant because lower physical activity levels are associated with increased mortality and increased hospitalisation in people with COPD. Pulmonary rehabilitation (PR) is an eight-week program involving exercise training, education and support. In our previous research, we developed a home-based model of PR for people with moderate to severe COPD. Our findings suggested promising results in improving physical activity levels and enhancing health related quality of life. People with even the mildest forms of COPD have been shown to have markedly reduced levels of physical activity. We believe that the benefits attained in our home based program for patients with more severe disease may also be achieved in people in the early-stages of COPD. As most individuals with early-stage COPD are managed in primary care (and many are still working), a home-based PR program may be more acceptable for this patient group. We hypothesise that a. pulmonary rehabilitation will result in clinically important improvement in six minute walk distance in people with GOLD stage I COPD; b. PR will improve dyspnoea, quality of life, and physical activity in GOLD stage I COPD. In this RCT we will recruit 58 people diagnosed with early stage, mild COPD according to the Global Initiative for Chronic Obstructive Lung Disease guidelines. Participants will be randomised to receive either usual care or home-based pulmonary rehabilitation program. Clinical measures will be recorded at baseline, 8 weeks-time point and 6 months. Outcome measures will include exercise capacity using change in 6 minutes walk distance, physical activity levels objectively measured by the sense wear armband (SWA), health related quality of life measured by change in the Chronic Respiratory Questionnaire and change in dyspnoea measured by the Modified Research Council Scale.

Interventions

Home-based pulmonary rehabilitation program (8 weeks): Participants are prescribed an exercise program by an experienced physiotherapist based on the results of their initial walking test. The exercise program consists of endurance (walking) and strengthening exercises. Participants are encouraged to exercise for 30 minutes, 5 times per week (including weekends). Strengthening exercises are performed using equipment that is available in the household (e.g. sit to stand from a chair, use of water

Home-based pulmonary rehabilitation program (8 weeks): Participants are prescribed an exercise program by an experienced physiotherapist based on the results of their initial walking test. The exercise program consists of endurance (walking) and strengthening exercises. Participants are encouraged to exercise for 30 minutes, 5 times per week (including weekends). Strengthening exercises are performed using equipment that is available in the household (e.g. sit to stand from a chair, use of water bottles as arm weights). To optimise safety and a full understanding of the exercise program, an initial home visit from the physiotherapist is arranged before the program launch. The home visit talks one hour and 30 minutes on average. This home visit session facilitates exercise goal setting and demonstrates exercises. The physiotherapist helps participants to choose strengthening exercise provided by the Better Living for COPD handbook according to their physical abilities and equipment available in their household. The physiotherapist then prescribe the strengthening exercise types, sets and repetitions for the participant and record them using the exercise diary provided. Assessment and correction of inhaler use is also carried out during the home visit. Weekly phone calls is then undertaken by the physiotherapist to review the exercise diary, perform self-management training and promote exercise progression. Each weekly phone calls takes approximately 20 to 30 minutes. Disease specific self-management training and exercise progression is achieved using the principles of motivational interviewing. The aims of this training are to advance disease knowledge, promote problem solving and facilitate health behaviour change. A physiotherapist trained in the use of motivational interviewing is performing the telephone calls. Discussions of exercise goals settings, exercise tracking and recognition and treatment of acute exacerbation is provided in home exercise diaries which are kept over 8 weeks. Participants are encouraged to track their progress against their goals on a daily basis. Home exercise diaries is delivered by the physiotherapist at the initial visit. Exercise diaries contains guidelines of identifying and managing moderate and severe exacerbation according to GOLD guidelines with an action plan, and contact details in case of emergencies. Following that, a goal setting sheet is provided to encourage goal setting at the start of every week with details about the time, location, and repetitions of exercises. A tracking sheet follows the goal setting sheet in order to help participants track their endurance and strengthening exercises daily.

Sponsors

La Trobe University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1- Participants must be diagnosed with mild COPD (GOLD stage I), defined as FEV1/FVC < 0.7 and postbronchodilator FEV1 >= 80% predicted 2- Participants must be over 40 years old of age 3- Participants must have a smoking history of not less than 10 packet years (current or former smokers)

Exclusion criteria

1- Acute exacerbation or hospitalisations during the last month before recruiting 2- Having a primary diagnosis of any other respiratory related disease such as Asthma or Restrictive Lung Disease 3- Having comorbidities that prevents exercise participation

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 19, 2026