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The Effect of Adding Exercise Training to Optimal Therapy in PAH

NCT02961023 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-08-20

No results posted yet for this study

Summary

Exercise capacity (EC) is limited in pulmonary arterial hypertension (PAH) by impaired right ventricular (RV) function and inability to increase stroke volume (SV). Disease targeted therapy, increases EC by improving SV. Additional factors may contribute to exercise limitation:

* Peripheral and respiratory muscle dysfunction
* Autonomic dysfunction
* An altered profile of inflammation
* Mitochondrial dysfunction.

The enhancement of EC achieved pharmacologically may therefore be limited. Exercise training in PAH improves EC and quality of life (QOL). The changes in physiology responsible for this improvement are not clear. Patients with PAH stable on optimal oral therapy, but not meeting treatment goals, will be enrolled in a 30-week randomised exercise training program.

One arm will undertake training for 15 weeks (3 weeks residential, 12 outpatient), the other will receive standard care for 15 weeks then 15 weeks training.

Aims:

1. Demonstrate that exercise training can enhance EC and QOL when added to optimal drug therapy a UK PAH population.
2. Explore mechanisms of exercise limitation and factors that improve with training, assessing:

* Cardiac function
* Skeletal muscle function
* Autonomic function
* Respiratory muscle strength
* Serum and muscle profile of inflammation

Primary outcomes (15 weeks)

1. 6 minute walk distance
2. QOL
3. RV ejection fraction

Conditions

Interventions

OTHER

Exercise therapy

3-week residential phase and 12-week outpatient phase. Residential phase * Exercise will be supervised by a physiotherapist and prescribed based on cardiopulmonary exercise testing. * A monitored daily program of exercise involving bicycle ergometry, walking, breathing exercises, dumbbell exercises 5 days per week. * 1.5 to 2 hours of exercise will be performed daily, with rest intervals. * At weekends, lower intensity, unsupervised exercise mirroring the outpatient phase * Ongoing exercise prescription will be based on tolerability, progress and HR Outpatient phase * A training manual will be compiled based on the subjects exercise performance during the residential program and tailored specifically to their needs * Participants will be provided with a cycle ergometer, weights and a HR monitor * Weekly telephone contact will be made by the study doctor or physiotherapist, with adjustments made to training prescription as necessary

Sponsors & Collaborators

  • National Health Service, United Kingdom

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2018-07-31
Completion
2018-07-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02961023 on ClinicalTrials.gov