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A phase 1 trial of exercise for patients admitted to hospital with acute exacerbation of chronic obstructive pulmonary disease (COPD)

A phase 1 trial of exercise for patients admitted to hospital with acute exacerbation of chronic obstructive pulmonary disease (COPD)- the safety and feasibility of exercise programme.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12608000605392
Enrollment
30
Registered
2008-12-03
Start date
2009-03-01
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

The effects of the exercise programme in the pulmonary rehabilitation has been thoroughly evaluated on people who are in their stable stage of COPD and the training has been proven to be very beneficial to this population (Lacasse et al.2003, (Nicki et al., 2006), (Carter & Nicotra, 1996; Mink, 1997). Benefits of exercise training include improved sense of well-being, increase in muscle metabolic capacity, reduction in lactic acid and increase in cross section of muscle fibres (Nicki et al., 2006). However, there are no trial investigating the possibility of implementing the exercise programme for patients who have been admitted for acute exacerbation of COPD. The primary aims of study is to investigate the safety and feasibility of implementing an exercise programme for patients with acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD) and also aim to establish the optimal intensity of exercise for in-patient exercise programme An estimated number of 30 participants will be recruited and assessed on the 1st or 2nd day following admission with the intention of commencing intervention from 2nd day of admission up to day of discharge. Out of the three groups, one will be the control group that received standard care and the other two will participate in a twice-daily 15 minutes exercise sessions during the trial duration in addition of standard physiotherapy treatment that the control group will be receiving. The two exercise groups will be exercising at either 40% or 70% maximal output intensity.

Interventions

Intervention group 1: Routine care (similiar to control group) with the addition of two fifteen minutes exercise session per day from the second day of admission to day of discharge. The exercise programme will include a walking programme and strengthening exercise. Participants in this group will be required to cover 70% of the distance that they achieve during the 3 minute walk test at initial assessment and perform 8-10 repetitions of each of the strengthening exercises. Intervention group 2

Intervention group 1: Routine care (similiar to control group) with the addition of two fifteen minutes exercise session per day from the second day of admission to day of discharge. The exercise programme will include a walking programme and strengthening exercise. Participants in this group will be required to cover 70% of the distance that they achieve during the 3 minute walk test at initial assessment and perform 8-10 repetitions of each of the strengthening exercises. Intervention group 2: Routine care in addition of identical exercise programme performed in intervention group 1 from second day of admission to day of discharge. However, participants in this group are only required to cover 40% of their distance achieved during their initial three minute walk test and perform 20-25 repetitions of each of the strengthening exercises.

Sponsors

Clarice Youci Tang
Lead SponsorIndividual

Study design

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

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

1. A primary admission diagnosis of acute exacerbation of COPD, or pneumonia or chest infection with a past medical history of COPD - All levels of severity will be considered 2. Able to ambulate independently or with minimal assistance of one person with/without a gait aid. 3. Able to obey two-stage commands, obtain a score of 15 on the Glasgow Coma Scale, be orientated to time, day and date and have no previous documented diagnosis of dementia 4. Patients are managed on the general medical wards. 5. Patients that are spontaneously ventilating and do not required any continuous assistance with ventilation. 6. Able to give informed consent to participate in the trial. 7. Must obtain approval of supervising medical officer that patient can participate in trial

Exclusion criteria

1. Patients who are clinically unstable as defined by below - Presence of hyperthermia (temperature of =380 Celsius) - Systolic pressure of <90 or >170mmHg - Diastolic pressure of >120mmHg - Unconscious or patients in a delirious state - Patients with severe respiratory acidosis with a blood pH < 7.3 (McKenzie et al., 2007) - Patients measured to have an acute cardiac arrhythmia during admission. - Patients who are tachycardiac with a resting heart rate >120 beats per minute. 2. Patients with other co-morbidities that may impair the ability to participate in an exercise programme (for example severe osteoarthritis, severe neurological conditions with residual deficits, severe low back pain and acute musculoskeletal injuries). 3. Patients who are acutely confused and unable to follow simple instructions. 4. - Patients admitted to the intensive care unit. - Patients admitted to short stay unit or Rapid Acute Medical Unit (RAMU) 5. Patients that required intubation and mechanical ventilation and/or admitted into intensive care. 6. Patients from a high-level or palliative care facility

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026