The effects of an exercise intervention on pulmonary function, respiratory muscle strength, aerobic capacity and perception of breathlessness in a representative population of patients with Idiopathic Parkinson's Disease
| ISRCTN | ISRCTN13611537 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13611537 |
| Protocol serial number | 12407 |
| Sponsor | Northumbria Healthcare NHS Foundation Trust (UK) |
| Funders | British Geriatrics Society (UK), Parkinson's UK (UK) |
- Submission date
- 03/10/2012
- Registration date
- 05/10/2012
- Last edited
- 06/08/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ailish O'Callaghan
Scientific
Scientific
North Tyneside General Hospital
Rake Lane
North Shields
NE29 8NH
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Treatment |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The effects of an exercise intervention on pulmonary function, respiratory muscle strength, aerobic capacity and perception of breathlessness in a representative population of patients with Idiopathic Parkinson's Disease |
| Study objectives | Many people with Idiopathic Parkinson's disease (IPD) suffer from respiratory symptoms including shortness of breath on exertion, cough and sputum production. Respiratory complications with IPD are a common reason for hospital admission and a higher proportion of people with IPD die from pneumonia than in the general population. Studies looking at lung function in IPD have produced varied, conflicting results. High quality research examining the effect of exercise on lung function is lacking. We plan to undertake the largest study to date, of 100 participants, to look at the lung function, breathing muscle strength, perception of breathlessness and blood gas levels in people with IPD. We will subsequently recruit 30 of the participants to a trial that looks at the effect of a 12 week exercise programme on the above measurements. We will also evaluate the effect of the exercise intervention on the amount of oxygen the body can use during exercise, the distance walked in 6 minutes and a selection of quality of life and well being measures. Blood tests will also be done to quantify the effect exercise has on the bodys secretion of brain derived neurotrophic factor, a protein secreted in response to activity that has the ability to signal neurons, the core components of the brain and spinal cord, to survive, become more specialised and grow. Exercise in IPD may also improve the brains ability to adapt to environmental change, respond to injury and obtain new information. |
| Ethics approval(s) | 12/NE/0188 |
| Health condition(s) or problem(s) studied | Topic: Dementias and Neurodegenerative Diseases Research Network; Subtopic: Parkinsons Disease; Disease: Parkinson's disease |
| Intervention | Exercise Programme, 30 particpants randomised 1:1 control:intervention groups. The 15 in the intervention group will have a 3x weekly structured exercise intervention for 12 weeks. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Aerobic Capacity at baseline and end of 12 weeks |
| Key secondary outcome measure(s) |
Pulmonary Function at baseline and end of 12 weeks |
| Completion date | 08/05/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | 1. Idiopathic Parkinsons Disease by the UK PD Society Brain Bank Criteria 2. Hoehn and Yahr Stage I-IV (I-III for RCT) 3. Ability to provide written informed consent 4. Aged 18 years or over |
| Key exclusion criteria | 1. Other forms of Parkinsonism e.g. drug induced 2. Significant medical conditions which would preclude lung function testing 3. Significant medical conditions which would preclude exercise (RCT group) 4. Pregnancy 5. Recent diagnosis of a blood clot, deep vein thrombosis, pulmonary embolism or myocardial infarction 6. Unstable cardiac status, haemoptysis, pneumothorax, thoracic, abdominal or cerebral aneurysm 7. Recent eye, thoracic or abdominal surgery |
| Date of first enrolment | 15/08/2012 |
| Date of final enrolment | 08/05/2015 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
North Tyneside General Hospital
North Shields
NE29 8NH
United Kingdom
NE29 8NH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2020 | 06/08/2020 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
06/08/2020: Publication reference added.
06/06/2018: No publications found, verifying study status with principal investigator.
