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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects | Experimental | All subjects will participate in the low-resistance training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-Resistance Training | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Safety will be assessed by way of the incidence of serious adverse events. | Between baseline and 12-week follow-up |
| Feasibility of Recruitment | Feasibility of recruitment will be assessed by measuring recruitment rates | Through study completion, an average of twice per year |
| Feasibility of Study | Feasibility of the study will be assessed by measuring retention rates. | 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. | 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. | Upon conclusion of the 12-week follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nadine Al-Naamani, MD, MS | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsyvania | Philadelphia | Pennsylvania | 19103 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 9, 2024 | Jun 18, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |