Pulmonary Arterial HypertensionNCT04808830
Prevalence of Musculoskeletal Pain and Its Impact on Quality of Life and Functional Exercise Capacity in Patients With Pulmonary Arterial Hypertension
An observational study of Pulmonary Arterial Hypertension, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Evaluation of musculoskeletal pain prevalence, Evaluation of quality of life and Evaluation of functional exercise capacity
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Mar 2021to 15 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients diagnosed with pulmonary arterial hypertension
Who may be able to join
- Diagnosis of pulmonary arterial hypertension
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa, Institute of Cardiology
Istanbul
About this study
Prevalence of musculoskeletal pain and its impact of quality of life and functional exercise capacity will be evaluated in patients with pulmonary arterial hypertension.
Read the 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.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Evaluation of musculoskeletal pain prevalence, Evaluation of quality of life, Evaluation of functional exercise capacity, Evaluation of physical activity level
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of musculoskeletal pain prevalenceOther
Prevalence of musculoskeletal pain will be evaluated over 9 body regions using The Nordic Musculoskeletal Questionnaire.
Evaluation of quality of lifeOther
Quality of life will be evaluated using The EmPHasis-10 questionnaire and The Minnesota Living with Heart Failure Questionnaire.
Evaluation of functional exercise capacityOther
Functional exercise capacity will be evaluated using 6-min walk test.
Evaluation of physical activity levelOther
Physical activity level will be evaluated using International Physical Activity Questionnaire- Short Form
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary arterial hypertension | Adult patients with pulmonary arterial hypertension Receives: Other: Evaluation of musculoskeletal pain prevalence; Other: Evaluation of quality of life; Other: Evaluation of functional exercise capacity; Other: Evaluation of physical activity level |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Nordic Musculoskeletal Questionnaire
The Nordic Musculoskeletal Questionnaire will be used to evaluate musculoskeletal pain prevalence.
Measured: At baseline
Secondary outcomes (4)
The EmPHasis-10 questionnaire
The EmPHasis-10 questionnaire will be used to measure quality of life.
Measured: At baseline
The Minnesota Living with Heart Failure Questionnaire
The Minnesota Living with Heart Failure Questionnaire will be used to measure quality of life.
Measured: At baseline
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).
Measured: At baseline
International Physical Activity Questionnaire - Short Form
International Physical Activity Questionnaire - Short Form will be used to measure physical activity level
Measured: At baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start25 Mar 2021
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Melih Zeren, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808830
- Sponsor's protocol ID
- bakircaymzeren02
- Status last verified
- Jun 2021
- First submitted
- 18 Mar 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Musculoskeletal Pain and Its Impact on Quality of Life and Functional Exercise Capacity in Patients With Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT04808830
- Acronym / sponsor ID
- bakircaymzeren02
- Conditions
- Pulmonary Arterial Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary arterial hypertension | – | Other: Evaluation of musculoskeletal pain prevalence, Other: Evaluation of quality of life, Other: Evaluation of functional exercise capacity, Other: Evaluation of physical activity levelAdult patients with pulmonary arterial hypertension |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with pulmonary arterial hypertension
Key inclusion criteria (1 listed)
- Diagnosis of pulmonary arterial hypertension
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of musculoskeletal pain prevalencePrevalence of musculoskeletal pain will be evaluated over 9 body regions using The Nordic Musculoskeletal Questionnaire. | Other | Pulmonary arterial hypertension |
| Evaluation of quality of lifeQuality of life will be evaluated using The EmPHasis-10 questionnaire and The Minnesota Living with Heart Failure Questionnaire. | Other | Pulmonary arterial hypertension |
| Evaluation of functional exercise capacityFunctional exercise capacity will be evaluated using 6-min walk test. | Other | Pulmonary arterial hypertension |
| Evaluation of physical activity levelPhysical activity level will be evaluated using International Physical Activity Questionnaire- Short Form | Other | Pulmonary arterial hypertension |
Primary outcome
The Nordic Musculoskeletal Questionnaire
Time frame: At baseline
The Nordic Musculoskeletal Questionnaire will be used to evaluate musculoskeletal pain prevalence.
4 secondary outcomes
The EmPHasis-10 questionnaire
Time frame: At baseline
The Minnesota Living with Heart Failure Questionnaire
Time frame: At baseline
6-min walk distance
Time frame: At baseline
International Physical Activity Questionnaire - Short Form
Time frame: At baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Nordic Musculoskeletal Questionnaire (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021; AzTrials last refreshed its copy on 8 Nov 2026.