Condition category
Circulatory System
Date applied
09/02/2015
Date assigned
30/03/2015
Last edited
13/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Sasiharan Sithamparanathan

ORCID ID

Contact details

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

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

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Sponsor details

Freeman Hospital
High Heaton
Newcastle
NE7 7DN
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes