Pulmonary Arterial HypertensionPhA-PAHNCT06312111
Physical Activity and Various Aspects of Quality of Life in Patients With Pulmonary Arterial Hypertension (Ph-PAH)
A study testing recommendation to increase physical activity in people with Pulmonary Arterial Hypertension and Physical Inactivity, run by Centre of Postgraduate Medical Education at 1 site in Poland.
Trial summary
Evaluate whether education, a simple doctor's recommendation to increase physical activity in inactive patients, and self-monitoring of physical activity using a pedometer were effective and beneficial for patients with pulmonary arterial hypertension (PAH) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension, Physical Inactivity
- What is being tested?
- recommendation to increase physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePoland
- Study dates
- 22 Apr 2021to 17 Jul 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age equal to or greater than 18 years
- PAH diagnosis according to current guidelines, confirmed by right heart catheterization
- optimal pharmacological treatment
- stable clinical condition at least 3 months before inclusion in the study
- Informed consent to participate in your own
Who cannot join
- Age under 18 years
- a type of hypertension other than PAH
- a neurological or orthopedic disease that prevents walking and performing the 6-minute walk test
- mental illness that prevents cooperation and assessment of quality of life survey
- lack of consent to participate in the study
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Pulmonary Circulation, Thromboembolic Diseases and Cardiology, European Health Centre, Otwock, Centre of Postgraduate Medical Education
Otwock, Borowa 14/18, 05-400
About this study
Official title: Assessment of Physical Activity and Various Aspects of Quality of Life in Patients With Pulmonary Arterial Hypertension
Evaluate whether education, a simple doctor's recommendation to increase physical activity in inactive patients, and self-monitoring of physical activity using a pedometer were effective and beneficial for patients with pulmonary arterial hypertension (PAH)
Read the detailed description
Each patient was educated about the benefits of PhA in PAH on the initial visit. Patients wore pedometers (Omron HJ-321-E) for 2 weeks. After PhA assessment, the patients were contacted by a physician. Patients who walked <5,000 steps per day were recommended to increase PhA, and patients who walked ≥5,000 steps per day were recommended to maintain PhA. Patients wore pedometers for 3 months until their next visit. The primary endpoint was the number of steps after 12 weeks of the study; the secondary endpoint was the 6-minute walk test distance (6MWD), quality of life (SF-36), acceptance of the disease, and anxiety and depression level (HADS).
- Being tested
- recommendation to increase physical activity
- Keywords
- pulmonary arterial hypertension, education, self-monitoring, physical activity, step count
- Medical subject headings
- Pulmonary Arterial Hypertension, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recommendation to increase physical activityBehavioural
education on the benefits of physical activity in PAH from the first visit and doctor's recommendation to increase physical activity above 5,000 steps a day in inactive patients and above 5,000 steps per person in active patients
| Study group | Role | What they receive |
|---|---|---|
| A physically inactive subgroup | Experimental | Patients who walked <5,000 steps per day during the first two weeks Receives: Behavioral: recommendation to increase physical activity |
| A physically active subgroup | Active comparator | Patients who walked >5,000 steps per day during the first two weeks Receives: Behavioral: recommendation to increase physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of steps per day
Number of steps per day monitored by pedometer Omron HJ-321-E
Measured: At baseline, after initial period 2 weeks
Secondary outcomes (7)
Change in 6-minute walk distance
Distance in six-minute walk test
Measured: At baseline, 3 months
Change in quality of life (SF-36)
Change in quality of life recorded by patient questionnaire 36-Item Short Form Health Survey (SF-36)
Measured: At baseline, 3 months
Change in the hospital anxiety and depression scale (HADS)
level of anxiety and depression measured by hospital anxiety and depression scale (HADS)
Measured: At baseline, 3 months
Change in the acceptance of illness (AIS)
acceptance of illness measured by acceptance of illness scale (AIS)
Measured: At baseline, 3 months
Change in N-Terminal Pro-B-Type Natriuretic Peptide level (NT-proBNP)
Blood sample to measure the concentration of N-terminal Pro-B type natriuretic peptide
Measured: At baseline, 3 months
Change in World Health Organization (WHO) functional Class recorded by investigator in conjunction with the 6MWD
WHO functional class assessment
Measured: At baseline, 3 months
Compliance with counting steps
Compliance with counting steps
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start22 Apr 2021
- Primary completion15 Jul 2021
- Study completion17 Jul 2022
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre of Postgraduate Medical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312111
- Sponsor's protocol ID
- 62/2021
- Acronym
- PhA-PAH
- Status last verified
- Mar 2024
- First submitted
- 8 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Physical Activity and Various Aspects of Quality of Life in Patients With Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT06312111
- Acronym / sponsor ID
- PhA-PAH / 62/2021
- Keywords
- pulmonary arterial hypertension, education, self-monitoring, physical activity, step count
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Centre of Postgraduate Medical EducationUniversity, hospital or other
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 17 Jul 2022 (actual)
- First posted
- 15 Mar 2024 (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.
Evaluate whether education, a simple doctor's recommendation to increase physical activity in inactive patients, and self-monitoring of physical activity using a pedometer were effective and beneficial for patients with pulmonary arterial hypertension (PAH)
Detailed description
Each patient was educated about the benefits of PhA in PAH on the initial visit. Patients wore pedometers (Omron HJ-321-E) for 2 weeks. After PhA assessment, the patients were contacted by a physician. Patients who walked <5,000 steps per day were recommended to increase PhA, and patients who walked ≥5,000 steps per day were recommended to maintain PhA. Patients wore pedometers for 3 months until their next visit. The primary endpoint was the number of steps after 12 weeks of the study; the secondary endpoint was the 6-minute walk test distance (6MWD), quality of life (SF-36), acceptance of the disease, and anxiety and depression level (HADS).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A physically inactive subgroup | Experimental | Behavioral: recommendation to increase physical activityPatients who walked <5,000 steps per day during the first two weeks |
| A physically active subgroup | Active comparator | Behavioral: recommendation to increase physical activityPatients who walked >5,000 steps per day during the first two weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age equal to or greater than 18 years
- PAH diagnosis according to current guidelines, confirmed by right heart catheterization
- optimal pharmacological treatment
- stable clinical condition at least 3 months before inclusion in the study
- Informed consent to participate in your own
Key exclusion criteria (5 listed)
- Age under 18 years
- a type of hypertension other than PAH
- a neurological or orthopedic disease that prevents walking and performing the 6-minute walk test
- mental illness that prevents cooperation and assessment of quality of life survey
- lack of consent to participate in the study
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 |
|---|---|---|
| recommendation to increase physical activityeducation on the benefits of physical activity in PAH from the first visit and doctor's recommendation to increase physical activity above 5,000 steps a day in inactive patients and above 5,000 steps per person in active patients | Behavioural | A physically active subgroup, A physically inactive subgroup |
Primary outcome
Number of steps per day
Time frame: At baseline, after initial period 2 weeks
Number of steps per day monitored by pedometer Omron HJ-321-E
7 secondary outcomes
Change in 6-minute walk distance
Time frame: At baseline, 3 months
Change in quality of life (SF-36)
Time frame: At baseline, 3 months
Change in the hospital anxiety and depression scale (HADS)
Time frame: At baseline, 3 months
Change in the acceptance of illness (AIS)
Time frame: At baseline, 3 months
Change in N-Terminal Pro-B-Type Natriuretic Peptide level (NT-proBNP)
Time frame: At baseline, 3 months
Change in World Health Organization (WHO) functional Class recorded by investigator in conjunction with the 6MWD
Time frame: At baseline, 3 months
Compliance with counting steps
Time frame: at 3 months
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 15 Mar 2024.
- Individual participant dataSharing planned: No
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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?
A study testing recommendation to increase physical activity in people with Pulmonary Arterial Hypertension and Physical Inactivity, run by Centre of Postgraduate Medical Education at 1 site in Poland.
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 5 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 15 Mar 2024. 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 Poland. 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?
Number of steps per day (time frame: At baseline, after initial period 2 weeks). 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 15 Mar 2024.