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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Arterial Hypertension
• Intervention / Treatment: Other: Evaluation of musculoskeletal pain prevalence; Other: Evaluation of quality of life; Other: Evaluation of functional exercise capacity; Other: Evaluation of physical activity level

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 Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul University-Cerrahpasa, Institute of Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients diagnosed with pulmonary arterial hypertension

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Pulmonary arterial hypertension; Adult patients with pulmonary arterial hypertension

Other: Evaluation of musculoskeletal pain prevalence; Prevalence of musculoskeletal pain will be evaluated over 9 body regions using The Nordic Musculoskeletal Questionnaire.; Other: Evaluation of quality of life; Quality of life will be evaluated using The EmPHasis-10 questionnaire and The Minnesota Living with Heart Failure Questionnaire.; Other: Evaluation of functional exercise capacity; Functional exercise capacity will be evaluated using 6-min walk test.; Other: Evaluation of physical activity level; Physical activity level will be evaluated using International Physical Activity Questionnaire- Short Form

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Nordic Musculoskeletal Questionnaire	The Nordic Musculoskeletal Questionnaire will be used to evaluate musculoskeletal pain prevalence.	At baseline

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Izmir Bakircay University
• Collaborators: Istanbul University - Cerrahpasa (IUC)

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2021
• Primary Completion (Actual): June 15, 2021
• Study Completion (Actual): June 15, 2021

Study Registration Dates

• First Submitted: March 18, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 17, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Musculoskeletal Pain
• Other Study ID Numbers: bakircaymzeren02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No