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

Pulmonary Arterial Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04808830
• Other study ID #: bakircaymzeren02
• Status: Completed
• Start date: March 25, 2021
• Est. completion date: June 15, 2021

Study information

• Verified date: June 2021
• Source: Izmir Bakircay University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: June 15, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Musculoskeletal Pain
• Pulmonary Arterial Hypertension

Intervention

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

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa, Institute of Cardiology	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Izmir Bakircay University	Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Nordic Musculoskeletal Questionnaire	The Nordic Musculoskeletal Questionnaire will be used to evaluate musculoskeletal pain prevalence.	At baseline
Secondary	The EmPHasis-10 questionnaire	The EmPHasis-10 questionnaire will be used to measure quality of life.	At baseline
Secondary	The Minnesota Living with Heart Failure Questionnaire	The Minnesota Living with Heart Failure Questionnaire will be used to measure quality of life.	At baseline
Secondary	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
Secondary	International Physical Activity Questionnaire - Short Form	International Physical Activity Questionnaire - Short Form will be used to measure physical activity level	At baseline.