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Exercise, immunity and vaccination in chronic obstructive pulmonary disease (COPD)

Exercise as an immunomodulatory intervention and adjuvant to vaccination in people with COPD: feasibility randomised controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000372583
Enrollment
10
Registered
2024-03-28
Start date
2024-06-25
Completion date
2027-10-03
Last updated
2026-08-31

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

Conditions

None listed

Brief summary

A sudden worsening of respiratory symptoms in Chronic obstructive Pulmonary Disease (COPD) is called a flare up. These flare ups are caused by respiratory infections. Exercise programs can reduce the number of people experiencing a flare up of COPD by as much as 40%. We don’t yet know why this happens. Key reasons why people with COPD have flare ups include weakened body defences (immune system) against respiratory infections. Measuring responses to safe, but foreign substances like vaccines provide one of the best ways to test how well the immune system defends against infections. We intend to find out if it is possible to use the flu or COVID-19 booster vaccines to understand how exercise changes the immune system of people with COPD. The project will recruit 45 volunteers with COPD. The project will split the volunteers into 3 groups: 1) 8 week exercise program before receiving a flu or COVID-19 vaccine; 2) 8 week exercise program before receiving a flu or COVID-19 vaccine and a single exercise session immediately after vaccination; 3) no exercise before or after flu or COVID-19 vaccine. We will collect blood and saliva from volunteers at the start of the project, before vaccination and on three occasions after vaccination.

Interventions

Arm 1: Exercise training Participants will undergo a standard outpatient pulmonary rehabilitation program or a telerehabilitation program at the Alfred Hospital in Melbourne. Decision on type of program will be based on participant preference or restrictions on face-to-face services at Alfred Health due to COVID-19. Both programs involve 8 weeks of twice-weekly supervised sessions with health professionals experienced in the delivery of pulmonary rehabilitation. Participants will undertake a

Arm 1: Exercise training Participants will undergo a standard outpatient pulmonary rehabilitation program or a telerehabilitation program at the Alfred Hospital in Melbourne. Decision on type of program will be based on participant preference or restrictions on face-to-face services at Alfred Health due to COVID-19. Both programs involve 8 weeks of twice-weekly supervised sessions with health professionals experienced in the delivery of pulmonary rehabilitation. Participants will undertake at least 30 minutes of lower limb aerobic training each session, which may be completed in shorter intervals if continuous training is limited by symptoms (e.g. 3 × 10 minutes). The training will consist of cycling on a cycle ergometer at a work rate equivalent to a Borg dyspnoea score of 3-4, which will be predicted from the baseline six-minute-walk-test (6MWT) in accordance with our previous research and published equations. Cycle training will be progressed by 5–15 % of the initial workload each week, aiming to maintain a Borg dyspnoea score of 3-4. For those receiving standard outpatient pulmonary rehabilitation this cycling will take place in groups of 8-12 at the Department of Physiotherapy of Alfred Health. For those receiving telerehabilitation program, participants will provided with all necessary equipment to complete the 8-week rehabilitation period at home. The telerehabilitation equipment ‘kit’ comprises of a step-through exercise bike to maximise safety (Bodyworkx A915), a 4G enabled tablet computer (Apple iPad, Apple, Cupertino, California, USA) with mobile data, fixed to a stand for video conferencing, and a pulse oximeter (Nonin Palmsat 2500A; Nonin Medical, Plymouth, Minnesota, USA) to monitor peripheral oxygen saturation and pulse rate during training and at rest. Their initial exercise training session will be undertaken during a home-visit with an Alfred Health physiotherapist. After the initial home-visit, the remaining 15 telerehabilitation sessions will be conducted in a virtual group of up to 6 participants. At the conclusion of the 8-week rehabilitation period the telerehabilitation equipment ‘kit’ will be removed from the participant's home by Alfred staff. The physiotherapist will conduct all telerehabilitation sessions from a closed office in Alfred Health equipped with a laptop computer and large display screen in line with standard delivery of this clinical service. Each rehabilitation session (outpatient rehabilitation or telerehabilitation) will also include 30 minutes of resistance exercise. Resistance training will be prescribed as tolerated, to achieve 8–12 repetitions for 3 sets of each exercise. Resistance training for the upper and lower limbs will be prescribed using functional activities. A minimum of four exercises, two each for the upper limb (e.g. wall push-ups, upright row, shoulder press) and lower limb (e.g. squats, sit-to-stand, step-ups), will be prescribed. Once able to perform three sets of 12 repetitions comfortably, weight will be increased. For lower limb exercises, this constituted the addition of hand weights or increasing squat depth as appropriate. Similar to the cycling component, participants completing the rehabilitation at the hospital will complete resistance exercise using equipment at the hospital. For participants in the telerehabilitation group, strength training will utilise appropriate and easily available household items (e.g. tins of soup or bags of rice) to substitute for free weights. All participants will be encouraged to perform an additional three unsupervised exercise sessions each week (i.e. on different days to the supervised twice-weekly sessions), which will be documented in a home exercise diary and reviewed weekly by the supervising clinician. Participants will be prescribed walking up to 30 minutes daily at the same pace as during the pulmonary rehabilitation program (Borg Dyspneoa score of 3-4). Resistance exercise will also be encouraged in these unsupervised sessions (three days per week) with similar circuit of exercises that are performed during the pulmonary rehabilitation program for up to 30 minutes. Participants receiving telerehabilitation will be free to use the provided equipment during these additional unsupervised sessions. At the end of the 8 weeks participants will be encouraged to continue unsupervised exercise, particularly for the remaining duration of the follow up. Arm 2: Exercise training + acute exercise In addition to the 8 weeks of exercise training (described above), participants will complete a single exercise session immediately after vaccination corresponding to the intensity (Borg Dyspneoa score of 3-4) and modality (aerobic and resistance) of the exercise training. This will take place at the Department of Physiotherapy of Alfred Hospital as one-on-one or in groups subject to availability of staff and timing of recruitment of participants. The intention will be to build on the 8 weeks of exercise training by achieving 90 minutes of exercise in this session (e.g. 30-60 minutes of walking and cycling and 30-60 minutes of resistance exercise subject to exercise tolerance) all at a Borg Dyspneoa score of 3-4) Vaccination: all participants Given the nature of this study, interventions and comparator treatment arms of the trial will be timed according to the availability of the vaccines. As part of standard care for people with COPD, all participants will receive a single dose of the annual Southern Hemisphere quadrivalent inactivated influenza vaccine or a COVID-19 booster. For the exercise training only group, vaccination will take place on the day following the final exercise session. For the control group, this will occur at the same point . The exercise training only group and the standard care group will receive vaccination at their usual health care facility or pharmacy. They will be instructed to go about their daily routine but avoid exercise on the day of the vaccination. The exercise training + acute exercise group will receive their vaccination on the day following the final exercise session of the training program but this may be administered by a respiratory nurse at the Alfred hospital (instead of their usual health care facility or pharmacy) in order for participants to complete their 90 minutes of exercise within 30 minutes of receiving the vaccine where possible. Any vaccination by a respiratory nurse at the Alfred Hospital will take place in accordance with usual practice at Alfred Health including under the supervision of a Respiratory Physician where required. Subject to Australian Technical Advisory Group on Immunisation (ATAGI) advice at the time of vaccination, influenza and COVID-19 vaccine may be co-administered (given on the same day). We will include participants who are yet to receive their influenza, COVID-19 booster or both.

Sponsors

Monash University
Lead SponsorUniversity

Study design

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

Eligibility

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

Inclusion criteria

- Adults (18 years or over) - Diagnosis of COPD (according to Global Initiative for Chronic Obstructive Lung Disease criteria: post bronchodilator FEV1/FVC ratio <0.70 - Disease severity classified as either GOLD C or D according to 2017 guidelines (Exacerbations in previous 12 months: greater than or equal to 2 courses of systemic corticosteroids and/or antibiotics or greater than or equal to 1 hospital admission

Exclusion criteria

- Already vaccinated with the influenza vaccine in the study season or not eligible for COVID-19 booster. - Any history of allergies, suspected hypersensitivity and/or contraindication to vaccines (e.g. egg protein allergy) - Participation in another clinical trial (use of investigational product or device) - Current enrolled on a structured physical activity programme or reports completing greater than or equal to 150 minutes of moderate intensity activity or greater than or equal to 75 minutes of vigorous intensity activity per week - Comorbidities that preclude exercise training - Clinical instability, defined as experiencing a COPD exacerbation less than 4 weeks prior to baseline visit, as indicated by treatment with systemic corticosteroids and/or antibiotics and/or hospitalisation - Diagnosis of asthma and/or other relevant lung disease (e.g. history of primary or clinically significant bronchiectasis, cystic fibrosis, bronchiolitis, lung resection, lung cancer, interstitial lung disease [e.g. fibrosis, silicosis, sarcoidosis], active tuberculosis) - Known alpha-1-antitrypsin deficiency - Primary immunodeficiency (e.g. common variable immune deficiency, agammaglobulinemia) or severe immunocompromised conditions (active haematological malignancy, long-term haemodialysis or peritoneal dialysis, advanced or untreated HIV) - Currently taking immunosuppressive medications except inhaled corticosteroids (e.g. prednisolone, cyclosporine, chemotherapy) - Not enrolled in Medicare - Unable to read and speak English

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 19, 2026