Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
12407
Study information
Scientific title
Acronym
Study hypothesis
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.
More details can be found at http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=12407
Ethics approval
12/NE/0188
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Aerobic Capacity at baseline and end of 12 weeks
Secondary outcome measures
Pulmonary Function at baseline and end of 12 weeks
Overall trial start date
15/08/2012
Overall trial end date
08/05/2015
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 100; UK Sample Size: 100
Participant 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
Recruitment start date
15/08/2012
Recruitment end date
08/05/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
North Tyneside General Hospital
North Shields
NE29 8NH
United Kingdom
Funders
Funder type
Charity
Funder name
British Geriatrics Society (UK)
Alternative name(s)
BGS
Funding Body Type
private sector organisation
Funding Body Subtype
professional associations and societies
Location
United Kingdom
Funder name
Parkinson's UK (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
professional associations and societies
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary