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

Completed

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Other: Evaluation of musculoskeletal pain prevalence; Other: Evaluation of quality of life; Other: Evaluation of functional exercise capacity; Other: Evaluation of physical activity level

• Registration Number: NCT04808830
• Lead Sponsor: Izmir Bakircay University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-03-18
• Study First Submitted QC: 2021-03-18
• Study First Posted: 2021-03-22
• Study Start: 2021-03-25
• Status Verified: 2021-06
• Primary Completion: 2021-06-15
• Study Completion: 2021-06-15
• Last Update Submitted: 2021-06-17
• Last Update Posted: 2021-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pulmonary arterial hypertension	Evaluation of functional exercise capacity	Adult patients with pulmonary arterial hypertension
Pulmonary arterial hypertension	Evaluation of musculoskeletal pain prevalence	Adult patients with pulmonary arterial hypertension
Pulmonary arterial hypertension	Evaluation of quality of life	Adult patients with pulmonary arterial hypertension
Pulmonary arterial hypertension	Evaluation of physical activity level	Adult patients with pulmonary arterial hypertension

Primary Outcome Measures

Name	Time	Method
The Nordic Musculoskeletal Questionnaire	At baseline	The Nordic Musculoskeletal Questionnaire will be used to evaluate musculoskeletal pain prevalence.

Secondary Outcome Measures

Name	Time	Method
The EmPHasis-10 questionnaire	At baseline	The EmPHasis-10 questionnaire will be used to measure quality of life.
The Minnesota Living with Heart Failure Questionnaire	At baseline	The Minnesota Living with Heart Failure Questionnaire will be used to measure quality of life.
6-min walk distance	At baseline	Distance walked in six minutes will be recorded. Test will be conducted according to the guideline of American Thoracic Society (ATS).
International Physical Activity Questionnaire - Short Form	At baseline.	International Physical Activity Questionnaire - Short Form will be used to measure physical activity level

Trial Locations

Locations (1)

Istanbul University-Cerrahpasa, Institute of Cardiology; 🇹🇷 Istanbul, Turkey