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Completed

NCT Number: NCT04808830

Prevalence of Musculoskeletal Pain and Its Impact on Quality of Life and Functional Exercise Capacity in Patients With Pulmonary Arterial Hypertension

Prevalence of musculoskeletal pain and its impact of quality of life and functional exercise capacity will be evaluated in patients with pulmonary arterial hypertension.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul University-Cerrahpasa, Institute of Cardiology

Istanbul, Turkey (Türkiye)

About this study

Although main symptoms of pulmonary arterial hypertension (PAH) include shortness of breath and exercise intolerance, patients may also experience symptoms related to musculoskeletal system such as muscle fatigue or pain. Due to insufficient cardiac output and chronic arterial hypoxemia, oxygen cannot be delivered to skeletal muscles sufficiently, especially during exertion. In addition, inflammation, which is thought to play an important role in pulmonary vascular remodeling and disease pathophysiology in these patients, affects skeletal muscles as well. Increased sympathetic tone in PAH restricts the perfusion of skeletal muscle by increasing peripheral vascular resistance. With the addition of physical inactivity to all these factors, skeletal muscle metabolism is further impaired. Furthermore, drugs used for the treatment of PAH may induce musculoskeletal pain as a side effect. Musculoskeletal pain is one of the most important factors impairing individual's quality of life, regardless of whether there is an underlying disease. Our aim in this study is to evaluate pain prevalence in the musculoskeletal system over 9 body regions, to compare the pain prevalence of patients using different types of PAH drugs and to examine impact of musculoskeletal pain on quality of life and functional capacity in patients with PAH.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of pulmonary arterial hypertension

Exclusion criteria

  • Diagnosis of heart failure or any chronic respiratory disease
  • Recent coronary bypass surgery
  • Recent acute myocardial infarction
  • Having a pacemaker
  • Having any orthopedic or neurologic diseases which may impede walking or exercising

Treatment and study plan

Evaluation of musculoskeletal pain prevalence

Other

Prevalence of musculoskeletal pain will be evaluated over 9 body regions using The Nordic Musculoskeletal Questionnaire.

Evaluation of quality of life

Other

Quality of life will be evaluated using The EmPHasis-10 questionnaire and The Minnesota Living with Heart Failure Questionnaire.

Evaluation of functional exercise capacity

Other

Functional exercise capacity will be evaluated using 6-min walk test.

Evaluation of physical activity level

Other

Physical activity level will be evaluated using International Physical Activity Questionnaire- Short Form

Primary outcomes

  1. The Nordic Musculoskeletal Questionnaire

    Time frame: At baseline

    The Nordic Musculoskeletal Questionnaire will be used to evaluate musculoskeletal pain prevalence.

Secondary outcomes

  1. The EmPHasis-10 questionnaire

    Time frame: At baseline

    The EmPHasis-10 questionnaire will be used to measure quality of life.

  2. The Minnesota Living with Heart Failure Questionnaire

    Time frame: At baseline

    The Minnesota Living with Heart Failure Questionnaire will be used to measure quality of life.

  3. 6-min walk distance

    Time frame: At baseline

    Distance walked in six minutes will be recorded. Test will be conducted according to the guideline of American Thoracic Society (ATS).

  4. International Physical Activity Questionnaire - Short Form

    Time frame: At baseline.

    International Physical Activity Questionnaire - Short Form will be used to measure physical activity level

Sponsors and collaborators

Lead sponsor

Izmir Bakircay University

Other

Collaborators

  • Istanbul University - Cerrahpasa

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 22, 2021
Registry last updated
Jun 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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