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Effect of a pulmonary rehabilitation program of 8 weeks duration compared to 12 weeks on exercise capacity in people with chronic obstructive pulmonary disease (PuRe Duration): A randomised controlled trial

Effect of a pulmonary rehabilitation program of 8 weeks duration compared to 12 weeks on exercise capacity in people with chronic obstructive pulmonary disease (PuRe Duration): A randomised controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001586404
Acronym
PuRe Duration
Enrollment
66
Registered
2016-11-16
Start date
2017-02-27
Completion date
Unknown
Last updated
2021-06-21

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

Conditions

None listed

Brief summary

Pulmonary rehabilitation (PR) guidelines and reviews of current research repeatedly state that PR programs should be between six and 12 weeks, with a recommended duration of eight weeks, but have been unable to draw significant conclusions regarding an optimal duration of PR programs to achieve improvements in exercise capacity and health-related quality of life. Aim : To evaluate the effect of an eight week pulmonary rehabilitation program compared to a 12 week program on exercise capacity and quality of life in people with COPD. Hypothesis: An eight week PR program is equivalent to a 12 week PR program at improving exercise capacity in people with COPD. Design: This is a multi-centre study where 68 participants will be recruited from pulmonary rehabilitation sites across the Sydney Local Health District. A randomised controlled trial design will be used with participants randomally allocated to one of two groups: 1. an eight week PR program or 2. a 12 week PR program. Participants will be asked to complete exercise tests and questionnaires at baseline, four weeks, eight weeks, 12 weeks, six months and 12 months follow-up. Participants will also be asked to wear physical activity monitors at baseline, seven weeks, at completion of their respective exercise programs (eight weeks or 12 weeks), six months and 12 months follow-up. This research will determine if an eight week PR program is equivalent to a 12 week PR program.

Interventions

Exercise training in a pulmonary rehabilitation program twice per week for 12 weeks. Programs are completed in an outpatient hospital setting and run by physiotherapists. Each training session will run for between 1 - 1.5 hours. Exercise training will consist of overground or treadmill walking, lower limb cycling, lower limb strengthening exercises (including body weight exercises; squats, sit to stands and step-ups and fixed weight exercises; leg press and leg extension) and upper limb exercis

Exercise training in a pulmonary rehabilitation program twice per week for 12 weeks. Programs are completed in an outpatient hospital setting and run by physiotherapists. Each training session will run for between 1 - 1.5 hours. Exercise training will consist of overground or treadmill walking, lower limb cycling, lower limb strengthening exercises (including body weight exercises; squats, sit to stands and step-ups and fixed weight exercises; leg press and leg extension) and upper limb exercises (including arm ergometry, lat pull-downs, chest press/fly and arm exercises with free weights). Initial exercise intensities will be standardised for each modality. Walking (overground or treadmill) will begin at 80% of peak walk speed determined by the six-minute walk test (6MWT) and progressed based on symptoms of dyspnoea and fatigue, with the aim of participants scoring a dyspnoea or fatigue score of at least 3-4 ('moderate' to 'somewhat severe') on the modified Borg dyspnoea 0-10 scale. Initial walking duration will be 10-15 minutes and progressed to 20-30 minutes between weeks 2-4. Lower limb cycling intensity will commence at 60% peak work rate using an equation based on the results of the 6MWT and progressed to 70% peak work rate based on symptoms of dyspnoea and fatigue, with the aim of participants scoring a dyspnoea or fatigue score of at least 3-4 on the modified Borg dyspnoea 0-10 scale. Arm ergometry will be performed for 10 minutes at a Borg score of 3-4 on the modified Borg dyspnoea 0-10 scale. Body weight lower limb strengthening exercises (squats, sit to stands and step ups) and arm free weight exercises will commence in week 2 at a load that can be achieved for 8 -10 repetitions before local muscle exhaustion. Fixed weight strengthening exercises for the lower limbs and upper limbs (leg extension, leg press, lat pull downs and chest press/fly) will commence in week 3 at a load that can be achieved for 8 -10 repetitions before local muscle exhaustion. By week 4, all strengthening exercise (body weight, free weight and fixed weight exercises) will be completed 3 times (i.e 3 sets). Resistances will be increased once participants can achieve 3 sets of 10 repetitions in two or more consecutive training sessions. Attendance will be monitored by the physiotherapists and participants will be encouraged to attend each allocated session.

Sponsors

Joshua Bishop
Lead SponsorIndividual

Study design

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

Eligibility

Sex/Gender
All
Age
40 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

a) have a medical diagnosis of COPD [forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC) <0.7 and an FEV1 between 20% and 80% predicted normal]. b) Referred to pulmonary rehabilitation.

Exclusion criteria

a) morbidly obese (BMI > 35 [kg/m2]). b) receiving long term oxygen therapy (LTOT). c) co-morbidities; either musculoskeletal, cardiovascular or neurological which would adversely affect exercise performance. d) have participated in a supervised exercise program within the last 12 months.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 17, 2026