Habitual physical activity and exercise capacity in pulmonary hypertension

ISRCTN ISRCTN14072554
DOI https://doi.org/10.1186/ISRCTN14072554
Secondary identifying numbers 7374
Submission date
09/02/2015
Registration date
30/03/2015
Last edited
26/05/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Sasiharan Sithamparanathan
Scientific

Newcastle upon Tyne NHS Foundation Trust
Freeman Hospital
Newcastle
NE7 7DN
United Kingdom

Study information

Study designSingle-centre pilot study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleHabitual physical activity and exercise capacity in pulmonary hypertension: a pilot study
Study objectivesHabitual physical activity and exercise capacity increases with targeted treatment for pulmonary hypertension.
Ethics approval(s)NRES Committee London - Westminister, 30/01/2015, ref: 15/LO/0144
Health condition(s) or problem(s) studiedPulmonary hypertension
InterventionAll 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measureThe change in peak oxygen consumption (VO2) with PH specific treatment.

Measured at baseline, 3 and 6 months
Secondary outcome measures1. 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 study start date01/03/2015
Completion date28/02/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants15
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/03/2015
Date of final enrolment30/11/2016

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Newcastle upon Tyne NHS Foundation Trust
Freeman Hospital
Freeman Road
High Heaton
Newcastle-upon-Tyne
NE7 7DN
United Kingdom

Sponsor information

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Freeman Hospital
High Heaton
Newcastle
NE7 7DN
England
United Kingdom

ROR logo "ROR" https://ror.org/05p40t847

Funders

Funder type

Hospital/treatment centre

Newcastle upon Tyne Hospitals NHS Trust
Government organisation / Local government
Alternative name(s)
Newcastle upon Tyne Hospitals NHS Trust
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planThe 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.

2018 results published in thesis: https://theses.ncl.ac.uk/jspui/bitstream/10443/4066/1/Sithamparanathan%2C%20S.%202018.pdf (added 26/05/2021)
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
HRA research summary 28/06/2023 No No

Editorial Notes

26/05/2021: Added link to thesis.