None listed
Conditions
Brief summary
Supplemental oxygen (O2) is the delivery of O2 when a person experiences O2 desaturation during activity. The use of supplemental O2 during exercise training for people with chronic obstructive pulmonary disease (COPD) is prescribed inconsistently and requires scientific evaluation. Since COPD is the second leading cause of avoidable hospital admissions and there are 47 percent of people with COPD referred to pulmonary rehabilitation who demonstrate O2 desaturation during exercise, whether to use supplemental O2 during exercise training is a substantial issue. Aim and Hypothesis: To determine whether supplemental O2 in people with COPD who desaturate during walking-based exercise provides greater benefit in exercise capacity and health-related quality of life than medical air. Exercise training with supplemental O2 will increase exercise capacity and health-related quality of life more than exercise training with medical air in people with COPD who desaturate during walking-based exercise. Design: This study is a national, multi-centre study where 110 participants with COPD will be recruited from sites in NSW, VIC, QLD, and WA. A prospective, double-blind, randomised controlled trial design will be used with COPD participants randomised into one of two groups: 1) receive intranasal cylinder O2 throughout exercise training (O2 group) or 2) receive intranasal cylinder medical air throughout exercise training (Air group). Participants will be asked to complete exercise tests and questionnaires at baseline, on completion of exercise training and at six month follow-up. This research will provide the first substantial and robust evidence regarding the role of supplemental O2 during exercise training for people with COPD who desaturate during exercise.
Interventions
Exercise Training with supplemental oxygen.
Supplemental oxygen will be delivered to this group using an oxygen concentrator. Oxygen will be administered at a rate of 5 L/min oxygen via nasal prongs.
Exercise training will consist of supervised ground walk training and lower limb cycling three times per week for eight weeks. Both modes of training will be performed as this reflects current practice in pulmonary rehabilitation. The initial exercise intensity for each mode of training will be st
Exercise Training with supplemental oxygen. Supplemental oxygen will be delivered to this group using an oxygen concentrator. Oxygen will be administered at a rate of 5 L/min oxygen via nasal prongs. Exercise training will consist of supervised ground walk training and lower limb cycling three times per week for eight weeks. Both modes of training will be performed as this reflects current practice in pulmonary rehabilitation. The initial exercise intensity for each mode of training will be standardized. For walking training, the initial intensity will be set at 80% of the six minute walk test speed. For cycle training, the initial intensity will be 60% of the peak work rate estimated from an equation based on the 6MWT published by our group. The initial duration of exercise training will be 30 minutes (20 minutes walk and 10 minutes cycle). The duration of exercise will be progressed, up to a total duration of 40 minutes (20 minutes walk and 20 minutes cycle) by week 3.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
45 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
People will be eligible for inclusion if they: a) have a medical diagnosis of COPD (forced expiratory volume in one second (FEV1) / forced vital capacity ratio of < 0.7; FEV1 between 20% to 80% predicted normal) b) oxygen saturation < 90% during a 6MWT performed breathing room air.
Exclusion criteria
People will be excluded if they: a) are receiving long term oxygen therapy or have a resting partial pressure of oxygen in arterial blood (PaO2) on room air less than or equal to 55 mmHg or have a resting PaCO2 greater then 50mmHg. b) have musculoskeletal, cardiovascular or neurological conditions likely to adversely affect performance during assessments or training. c) have participated in supervised exercise training within the last 12 months.
Outcome results
None listed