Pulmonary HypertensionNCT03762577
Effects of Ground-based Walking Training in Pulmonary Hypertension
A study testing Ground-based walking training in people with Pulmonary Hypertension, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Pulmonary Hypertension (PH) is a hemodynamic and physiopathological condition that is defined as an increase in pulmonary artery pressure ≥25 mmHg when measured at resting with symptoms such as dyspnea, fatigue, chest pain, and syncope. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Ground-based walking training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2018to 4 Mar 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years
- Diagnosed with PH
- Followed by the department of chest diseases at least six months
- Not participating in the rehabilitation program in last year
Who cannot join
- Functional group four due to WHO functional classification
- PH due to left heart diseases, PH due to lung diseases and/or hypoxia
- Treatment and medication change in the last three months
- Cooperation problems
- Patients with successful pulmonary endarterectomy operation
- Smoking
Show all 9Show fewer
- Patients with uncontrolled cardiovascular diseases
- Patients with orthopeadic and/or neurologic disorders that could limit exercise tests
- Syncope history in recent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Ground-based Walking Training for Adult Patients With Pulmonary Hypertension
Pulmonary Hypertension (PH) is a hemodynamic and physiopathological condition that is defined as an increase in pulmonary artery pressure ≥25 mmHg when measured at resting with symptoms such as dyspnea, fatigue, chest pain, and syncope. PH characterized by decreased exercise capacity, quality of life, peripheral muscle strength, balance, and physical inactivity. It is recommended that patients with PH should be included in cardiopulmonary rehabilitation programs in addition to medical treatment. Ground-based walking training is a safe and effective method for COPD patients. In the literature, there are no studies evaluating the effects of ground-based walking training in PH patients.
Read the detailed description
The aim of this project is to determine the effect of ground-based walking training on physical activity, exercise capacity, balance, peripheral muscle strength and quality of life in patients with PH.
- Conditions
- Pulmonary Hypertension
- Being tested
- Ground-based walking training
- Keywords
- Pulmonary Hypertension, Walking Training, Exercise, Balance, Quality of Life
- Medical subject headings
- Hypertension, Pulmonary, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ground-based walking trainingOther
Patients will attend a 2-day 30-minute ground-based walking training under the supervision of a physiotherapist. Patients will walk for 1-2 days in a week without supervision. According to the Modified Borg Scale, the dyspnea intensity will be 3-4 (medium to slightly difficult) and the heart rate will be completed to not exceed 120 min / pulse. Heart rate of patients will be followed by finger type pulse oximeter
| Study group | Role | What they receive |
|---|---|---|
| Training Group | Experimental | Training group will attend ground-based walking training under the supervision of a physiotherapist for 2 days and 30 minutes a week. Patients will walk for 1-2 days in a week without supervision. Receives: Other: Ground-based walking training |
| Control Group | No intervention | Patient education will be given and no intervention will be made. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endurance exercise capacity
endurance shuttle walk test
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start10 Dec 2018
- Primary completion4 Mar 2020
- Study completion4 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozge Ertan, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762577
- Sponsor's protocol ID
- 30146
- Status last verified
- Mar 2020
- First submitted
- 28 Nov 2018
- Last updated
- 25 Mar 2020
- 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 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Ground-based Walking Training for Adult Patients With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT03762577
- Acronym / sponsor ID
- 30146
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary Hypertension, Walking Training, Exercise, Balance, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 4 Mar 2020 (actual)
- Study completion
- 4 Mar 2020 (actual)
- First posted
- 3 Dec 2018 (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.
Pulmonary Hypertension (PH) is a hemodynamic and physiopathological condition that is defined as an increase in pulmonary artery pressure ≥25 mmHg when measured at resting with symptoms such as dyspnea, fatigue, chest pain, and syncope. PH characterized by decreased exercise capacity, quality of life, peripheral muscle strength, balance, and physical inactivity. It is recommended that patients with PH should be included in cardiopulmonary rehabilitation programs in addition to medical treatment. Ground-based walking training is a safe and effective method for COPD patients. In the literature, there are no studies evaluating the effects of ground-based walking training in PH patients.
Detailed description
The aim of this project is to determine the effect of ground-based walking training on physical activity, exercise capacity, balance, peripheral muscle strength and quality of life in patients with PH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training Group | Experimental | Other: Ground-based walking trainingTraining group will attend ground-based walking training under the supervision of a physiotherapist for 2 days and 30 minutes a week. Patients will walk for 1-2 days in a week without supervision. |
| Control Group | No intervention | –Patient education will be given and no intervention will be made. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-80 years
- Diagnosed with PH
- Followed by the department of chest diseases at least six months
- Not participating in the rehabilitation program in last year
Key exclusion criteria (9 listed)
- Functional group four due to WHO functional classification
- PH due to left heart diseases, PH due to lung diseases and/or hypoxia
- Treatment and medication change in the last three months
- Cooperation problems
- Patients with successful pulmonary endarterectomy operation
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 |
|---|---|---|
| Ground-based walking trainingPatients will attend a 2-day 30-minute ground-based walking training under the supervision of a physiotherapist. Patients will walk for 1-2 days in a week without supervision. According to the Modified Borg Scale, the dyspnea intensity will be 3-4 (medium to slightly difficult) and the heart rate will be completed to not exceed 120 min / pulse. Heart rate of patients will be followed by finger type pulse oximeter | Other | Training Group |
Primary outcome
Endurance exercise capacity
Time frame: 8 weeks
endurance shuttle walk test
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 25 Mar 2020.
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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 Ground-based walking training in people with Pulmonary Hypertension, run by Istanbul 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 4 inclusion and 9 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 25 Mar 2020. 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?
Endurance exercise capacity (time frame: 8 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 25 Mar 2020.