Condition category
Nervous System Diseases
Date applied
03/10/2012
Date assigned
05/10/2012
Last edited
05/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ailish O'Callaghan

ORCID ID

Contact details

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

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 body’s 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 brain’s 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: Parkinson’s 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 Parkinson’s 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

Sponsor information

Organisation

Northumbria Healthcare NHS Foundation Trust (UK)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes