Plain English Summary
Background and study aims
Pulmonary hypertension (PH) is a serious health condition caused by raised blood pressure within the pulmonary arteries (the blood vessels going to the lungs). It can result in damage to the right side of the heart, so that it isn’t able to pump blood around the body as well as it should. PH is a debilitating disease with symptoms including shortness of breath, fatigue, feeling faint and dizzy, chest pain and tachycardia (irregular heart beat). The condition can have severe effects on a person’s quality of life. As the symptoms are non-specific and possibly due to a number of other causes, diagnosis of PH and referral to appropriate specialists can be delayed resulting in worsening of the patients condition. Management of PH focuses on both supportive therapy and target driven drug therapies. Support management includes diuretics, oxygen, and digoxin (a heart drug). Modern drug therapy has led to a significant improvement in patient symptoms and has slowed the rate of clinical deterioration. Exercise training in number of recent studies has been shown to be beneficial in improving quality of life and increase the amount of exercise the patients can do (exercise capacity). Despite the use of medications and exercise, patients remain symptomatic with a poor quality of life and prognosis. Recent clinical studies have shown that PH leads to weakness of the muscles and leads to both an increase in muscle protein breakdown and changes in muscle fibre types. We need greater understanding of the effect of currently accepted treatment for PH on a patients physical activity and ability to exercise. Only then can we focus on the role of resistance training in improving symptoms and function in PH patients. Mitochrondria are found within cells and generate energy for cell function. This study will involve research into the function of muscles of PH patients and activity of mitochrondria in muscle cells using a functioning imaging technique.
Who can participate?
Adults (aged over 18) diagnosed with PH.
What does the study involve?
Participants undergo a course of targeted pulmonary hypertension therapy. During this time they are asked to complete two questionnaires at different points in the study. They also wear an accelerometer and do a cardiopulmonary exercise test at the start of the study, after 3 months and then after 6 months. We look closely at how muscles extract and use oxygen over a time course of standard care. This study will help us develop potential new exercise rehabilitation programme particularly the role of resistance training in pulmonary hypertension.
What are the possible benefits and risks of participating?
There are no risk from wearing the accelerometer. Cardiopulmonary exercise testing will be supervised in a hospital and is considered a relatively safe procedure to undergo in patients with pulmonary hypertension, with rare risk of arrhythmia arising requiring treatment.
Where is the study run from?
Newcastle upon Tyne NHS Foundation Trust, Freeman Hospital (UK)
When is the study starting and how long is it expected to run for?
March 2015 to February 2017
Who is funding the study?
Newcastle upon Tyne Hospitals NHS Trust (UK)
Who is the main contact?
Dr Sasiharan Sithamparanathan
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
7374
Study information
Scientific title
Habitual physical activity and exercise capacity in pulmonary hypertension: a pilot study
Acronym
Study hypothesis
Habitual physical activity and exercise capacity increases with targeted treatment for pulmonary hypertension.
Ethics approval
NRES Committee London - Westminister, 30/01/2015, ref: 15/LO/0144
Study design
Single-centre pilot study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Pulmonary hypertension
Intervention
All patients deemed necessary will undergo initiation of targeted pulmonary hypertension therapy. They will be followed up at baseline, 3 and 6 months with quality of life scores, monitoring their activity levels and undergoing cardiopulmonary exercise tests.
Intervention type
Drug
Phase
Not Applicable
Drug names
Primary outcome measures
The change in peak oxygen consumption (VO2) with PH specific treatment.
Measured at baseline, 3 and 6 months
Secondary outcome measures
1. Change in habitual physical activity levels with treatment.
2. Change in cardiac output and peripheral muscle oxygen extraction during exercise with PH-specific treatment.
Measured at baseline, 3 and 6 months
Overall trial start date
01/03/2015
Overall trial end date
28/02/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients’ aged greater than 18 years
2. Underlying diagnosis of pulmonary hypertension confirmed by the National Pulmonary Hypertension Service(Newcastle)
3. World Health Organization (WHO) functional Class II to IV
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
15
Participant exclusion criteria
1. Patients who are unable to provide informed consent
2. Patients with recent syncope
3. Patients with known skeletal and muscle abnormalities
4. Patients with ischaemic heart disease
Recruitment start date
01/03/2015
Recruitment end date
30/11/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Newcastle upon Tyne NHS Foundation Trust
Freeman Hospital
Freeman Road
High Heaton
Newcastle-upon-Tyne
NE7 7DN
United Kingdom
Funders
Funder type
Hospital/treatment centre
Funder name
Newcastle upon Tyne Hospitals NHS Trust
Alternative name(s)
Newcastle upon Tyne Hospitals NHS Trust
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The intention is to publish the change in physical activity with treatment to inform us the potential of this method as a biomarker of treatment response.We will also look at the change in cardiac output with exercise with treatment and the correlation between physical activity and CPEX readings.
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary