Pulmonary Arterial HypertensionRESIST-PHNCT06543745
Safety and Impact of Low Resistance Exercise Training on Quality of Life in Pulmonary Arterial Hypertension
A study testing Low-Resistance Training in people with Pulmonary Arterial Hypertension and Frailty, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of the study is to learn more about how low-resistance training impacts frailty and the quality of life of people with pulmonary arterial hypertension (PAH). Low-resistance training is an evidence-based approach that may help patients improve their functional ability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension, Frailty
- What is being tested?
- Low-Resistance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2024to 31 Mar 2026
- 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
- Diagnosis of PAH: idiopathic, heritable, associated with connective tissue disease, congenital heart disease, human immunodeficiency virus, drug- or toxin, or portopulmonary hypertension
- On stable PAH therapy for 3 months
Who cannot join
- World Health Organization (WHO) functional class IV
- Left ventricular ejection fraction < 40% (via transthoracic echocardiogram (TTE) within one year of screening)
- Moderate or severe concomitant lung disease: Chronic Obstructive Pulmonary Disease (COPD) or interstitial lung disease
- Enrollment in a clinical trial
- Recent hospitalization (within 4 weeks of screening)
- Inability to perform the Short Physical Performance Battery or wheelchair bound
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsyvania
Philadelphia, Pennsylvania, 19103
About this study
The purpose of the study is to learn more about how low-resistance training impacts frailty and the quality of life of people with pulmonary arterial hypertension (PAH). Low-resistance training is an evidence-based approach that may help patients improve their functional ability.
Read the detailed description
Patients with pulmonary arterial hypertension and their caregivers will be asked to participate in the study. The study consists of a baseline in-person visit (week 1) where quality of life and physical performance will be assessed, and subjects will be shown low-resistance training exercises to perform at home. The exercises will then be performed at home, as instructed, for 12 weeks. At week 12, subjects return for a follow-up in-person visit, where quality of life and physical performance will be reassessed. Patients and caregivers will also be asked to participate in separate exit interviews, where investigators will ask how they felt about the resistance training.
- Conditions
- Pulmonary Arterial Hypertension, Frailty
- Being tested
- Low-Resistance Training
- Medical subject headings
- Pulmonary Arterial Hypertension, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Resistance TrainingBehavioural
The following 6 exercises will be performed in 3 sets of 15-15-15 repetitions, 3 times per week for 12 weeks:
Elbow Flexion, Elbow Extension, Lateral Hip Extensions, Hip Extensions, Knee Extensions, Wall push-ups
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Experimental | All subjects will participate in the low-resistance training Receives: Behavioral: Low-Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Safety will be assessed by way of the incidence of serious adverse events.
Measured: Between baseline and 12-week follow-up
Feasibility of Recruitment
Feasibility of recruitment will be assessed by measuring recruitment rates
Measured: Through study completion, an average of twice per year
Feasibility of Study
Feasibility of the study will be assessed by measuring retention rates.
Measured: Through study completion, an average of twice per year
Short Performance Physical Battery (SPPB) and emPHasis-10 (E10) scores
Investigators will use a change in score for SPPB and E10 scores, using Wilcoxon signed-rank test.
Measured: Between baseline and 12-week follow-up
Patient/ Caregiver Exit Interview
Each subject (both patients who participate in the study and their caregivers, separately) will be asked to review their experience with the study protocol, rating their satisfaction on a 5 point Likert scale (1 being Strongly Disagree, 5 being Strongly Agree) with the overall protocol, ease of exercises, acceptability of equipment and exercises. Higher scores (eg. agreement of a positive experience) mean a better outcome.
Measured: Upon conclusion of the 12-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start4 Sep 2024
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
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.
- More trials run by University of PennsylvaniaThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadine Al-Naamani, MD, MS, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543745
- Sponsor's protocol ID
- 855504
- Acronym
- RESIST-PH
- Status last verified
- Aug 2026
- First submitted
- 20 Jun 2024
- Last updated
- 6 Aug 2026
- 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 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Impact of Low Resistance Exercise Training on Quality of Life in Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT06543745
- Acronym / sponsor ID
- RESIST-PH / 855504
- Conditions
- Pulmonary Arterial Hypertension, Frailty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 9 Aug 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.
The purpose of the study is to learn more about how low-resistance training impacts frailty and the quality of life of people with pulmonary arterial hypertension (PAH). Low-resistance training is an evidence-based approach that may help patients improve their functional ability.
Detailed description
Patients with pulmonary arterial hypertension and their caregivers will be asked to participate in the study. The study consists of a baseline in-person visit (week 1) where quality of life and physical performance will be assessed, and subjects will be shown low-resistance training exercises to perform at home. The exercises will then be performed at home, as instructed, for 12 weeks. At week 12, subjects return for a follow-up in-person visit, where quality of life and physical performance will be reassessed. Patients and caregivers will also be asked to participate in separate exit interviews, where investigators will ask how they felt about the resistance training.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | Experimental | Behavioral: Low-Resistance TrainingAll subjects will participate in the low-resistance training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of PAH: idiopathic, heritable, associated with connective tissue disease, congenital heart disease, human immunodeficiency virus, drug- or toxin, or portopulmonary hypertension
- On stable PAH therapy for 3 months
Key exclusion criteria (6 listed)
- World Health Organization (WHO) functional class IV
- Left ventricular ejection fraction < 40% (via transthoracic echocardiogram (TTE) within one year of screening)
- Moderate or severe concomitant lung disease: Chronic Obstructive Pulmonary Disease (COPD) or interstitial lung disease
- Enrollment in a clinical trial
- Recent hospitalization (within 4 weeks of screening)
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 |
|---|---|---|
| Low-Resistance TrainingThe following 6 exercises will be performed in 3 sets of 15-15-15 repetitions, 3 times per week for 12 weeks: Elbow Flexion, Elbow Extension, Lateral Hip Extensions, Hip Extensions, Knee Extensions, Wall push-ups | Behavioural | All subjects |
Primary outcome
Adverse Events
Time frame: Between baseline and 12-week follow-up
Safety will be assessed by way of the incidence of serious adverse events.
Feasibility of Recruitment
Time frame: Through study completion, an average of twice per year
Feasibility of recruitment will be assessed by measuring recruitment rates
Feasibility of Study
Time frame: Through study completion, an average of twice per year
Feasibility of the study will be assessed by measuring retention rates.
Short Performance Physical Battery (SPPB) and emPHasis-10 (E10) scores
Time frame: Between baseline and 12-week follow-up
Investigators will use a change in score for SPPB and E10 scores, using Wilcoxon signed-rank test.
Patient/ Caregiver Exit Interview
Time frame: Upon conclusion of the 12-week follow-up
Each subject (both patients who participate in the study and their caregivers, separately) will be asked to review their experience with the study protocol, rating their satisfaction on a 5 point Likert scale (1 being Strongly Disagree, 5 being Strongly Agree) with the overall protocol, ease of exercises, acceptability of equipment and exercises. Higher scores (eg. agreement of a positive experience) mean a better outcome.
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 6 Aug 2026.
- 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.
Nadine Al-Naamani, MD, MS principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Resistance Training in people with Pulmonary Arterial Hypertension and Frailty, run by University of Pennsylvania at 1 site in United States.
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 2 inclusion and 6 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 6 Aug 2026. 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 United States. 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?
Adverse Events (time frame: Between baseline and 12-week follow-up). The study lists 5 primary outcomes in all. 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 6 Aug 2026.