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Does tailoring a pulmonary rehabilitation programme with data from a maximal exercise cycle test data lead to better outcomes than traditional exercise prescription methods? A pilot study.

Evaluation of a pulmonary rehabilitation (PR) program using an exercise prescription that includes the maximal exercise cycle test (MECT) compared to a PR program using an exercise prescription that does not includes the MECT on exercise capacity in patients with chronic obstructive pulmonary disease

Status
Suspended
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000769684
Enrollment
40
Registered
2014-07-21
Start date
2014-07-01
Completion date
Unknown
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

This pilot study will provide information regarding effect sizes, distribution of results and the feasibility of comparing two PR approaches: a PR approach in which the MECT is added to the PR assessment to further tailor the intervention and a PR approach that will not require this MECT information. Data from this pilot study will inform the investigators regarding the design of a larger multi-centre RCT to evaluate the effectiveness of both exercise prescription approaches in pulmonary rehabilitation

Interventions

Intervention group: Patients with COPD receiving a PR program using an exercise prescription that includes a Maximal Exercise Capacity Test (MECT) The intervention group will be assessed using the MECT measured by cycle ergometer test. Measurements of ventilation and gas exchange will be made via with a calibrated flow sensor and gas analysers (OxyCon Pro; CareFusion Jaeger) with the patient breathing from a low deadspace ventilation mask sealed around the patient’s mouth and nose. The test wil

Intervention group: Patients with COPD receiving a PR program using an exercise prescription that includes a Maximal Exercise Capacity Test (MECT) The intervention group will be assessed using the MECT measured by cycle ergometer test. Measurements of ventilation and gas exchange will be made via with a calibrated flow sensor and gas analysers (OxyCon Pro; CareFusion Jaeger) with the patient breathing from a low deadspace ventilation mask sealed around the patient’s mouth and nose. The test will be based on the American Thoracic Society and American College of Chest Physicians protocol (ATS/ACCP, 2003). The patient will be asked to start with a resting phase of 3 minutes followed by 3 minutes of unloaded pedaling prior to the incremental phase. The intensity will be increased every minute by 5-25 W until patient reaches exhaustion or cannot maintain a pedaling rate of above 50 RPM. The patients will be strongly encouraged to maintain the pedaling rate. Breath-by-breath data analysis provides carbon dioxide production, oxygen consumption, tidal volume, breathing frequency, and minute ventilation can be determined. Maximum working capacity (Wmax) will be calculated as a percentage of predicted value depending on age, gender, and body mass index (Bruce et al., 1973; Hansen et al., 1984). Electrocardiogram and oxygen saturation will be continuously monitored during the test (Vonbank et al., 2012). The incremental phase will be completed between 8-12 minutes (Gloeckl et al., 2013). At the start, during, and end of the test patients will rate their breathlessness and fatigue using modified Borg scale (Borg, 1982). The data of this test will be used to tailor the PR intervention to the individual patients. All MECTs will be medically supervised. The test will be performed on a stationary bike. MECT data will be used by the physiotherapist to define the training approach (endurance or interval training) and the intensity of the exercises in the training. For the first 8 weeks, patients will have one 2-hour education session and 2 60-minute exercise sessions per week. The last 4 weeks, the patients continue with 2 60-minute exercise sessions per week, but do not have any further education sessions. The sessions are group-based sessions. The program is 12 weeks long. It has two groups of total 20-30 patients. Each group has 10-15 patients. The two sessions will start at the same time (i.e. morning and afternoon), where participants who attend the exercise in the morning will attend the education session in the afternoon and vice versa. The education topic areas are, but not limited to, self-Management, the Lungs and COPD management, medications, managing breathlessness, exercise and physical activity, nutrition and healthy eating, stress, anxiety and depression, airway clearance, energy conservation, continence, sexuality issues, swallowing and home oxygen. There will be one physiotherapist and one assistant per group. In the training, patients will have five different exercises; cycling, walking, walking stairs, lifting weights, and unsupported arm lifting.The exercise protocol is an adjusted version of a protocol which was proven effective in a previous study (Effing et al., 2011).

Sponsors

Repatriation General Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No

Inclusion criteria

1) Referred to and selected for the PR at the Repatriation General Hospital. 2) At least six weeks since last hospitalization or four weeks since last exacerbation of respiratory condition.

Exclusion criteria

1) life expectancy of less than 12 months. 2) significant comorbidity including malignancy, cardiovascular disease, or musculoskeletal disease that severely limits performing exercise-training tasks and participation into the PR program. 3) severe psychiatric illness. 4) can not understand/read English.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026