NCT04808830

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 22, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

March 25, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

3 months

First QC Date

March 18, 2021

Last Update Submit

June 17, 2021

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

  • The Nordic Musculoskeletal Questionnaire

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

    At baseline

Secondary Outcomes (4)

  • The EmPHasis-10 questionnaire

    At baseline

  • The Minnesota Living with Heart Failure Questionnaire

    At baseline

  • 6-min walk distance

    At baseline

  • International Physical Activity Questionnaire - Short Form

    At baseline.

Study Arms (1)

Pulmonary arterial hypertension

Adult patients with pulmonary arterial hypertension

Other: Evaluation of musculoskeletal pain prevalenceOther: Evaluation of quality of lifeOther: Evaluation of functional exercise capacityOther: Evaluation of physical activity level

Interventions

Evaluation of musculoskeletal pain prevalenceOTHER

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

Pulmonary arterial hypertension
Evaluation of quality of lifeOTHER

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

Pulmonary arterial hypertension
Evaluation of functional exercise capacityOTHER

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

Pulmonary arterial hypertension
Evaluation of physical activity levelOTHER

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

Pulmonary arterial hypertension

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients diagnosed with pulmonary arterial hypertension

You may qualify if:

  • Diagnosis of pulmonary arterial hypertension

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa, Institute of Cardiology

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof. Dr.

Study Record Dates

First Submitted

March 18, 2021

First Posted

March 22, 2021

Study Start

March 25, 2021

Primary Completion

June 15, 2021

Study Completion

June 15, 2021

Last Updated

June 18, 2021

Record last verified: 2021-06

Locations

TU(1)