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
Secondary identifying numbers	12407

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

North Tyneside General Hospital
Rake Lane
North Shields
NE29 8NH
United Kingdom

Study information

Study design	Randomised; Interventional; Design type: Treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient 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	Aerobic Capacity at baseline and end of 12 weeks
Secondary outcome measures	Pulmonary Function at baseline and end of 12 weeks
Overall study start date	15/08/2012
Completion date	08/05/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 100; UK Sample Size: 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

England
United Kingdom

Study participating centre

North Tyneside General Hospital

North Shields
NE29 8NH
United Kingdom

Sponsor information

Northumbria Healthcare NHS Foundation Trust (UK)
Hospital/treatment centre

North Tyneside General Hospital
Rake Lane
North Shields
NE29 8NH
England
United Kingdom

"ROR"	https://ror.org/01gfeyd95

Funders

Funder type

Charity

British Geriatrics Society (UK)
Private sector organisation / Associations and societies (private and public)

Alternative name(s): BGS
Location: United Kingdom

Parkinson's UK (UK)
Private sector organisation / Associations and societies (private and public)

Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
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

Editorial Notes

06/08/2020: Publication reference added.
06/06/2018: No publications found, verifying study status with principal investigator.