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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23HL164901-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The investigators are doing this research study to compare whole body aerobic training with isolated leg training (with weights) and its impact on effectiveness in symptoms and quality of life in patients with Pulmonary Arterial Hypertension (PAH).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerobic Training | Active Comparator | Subjects with PAH will be enrolled to complete baseline study assessments, be randomized to undergo aerobic training for 12 weeks, and then repeat study assessments. |
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| Leg Training | Experimental | Subjects with PAH will be enrolled to complete baseline study assessments, be randomized to undergo leg training for 12 weeks, and then repeat study assessments. |
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| Healthy Controls | No Intervention | Healthy controls will be enrolled to complete the baseline study assessments for generation of normal reference values for comparison. Healthy controls will not undergo randomized exercise training interventions or repeat assessments. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic Training | Behavioral | Aerobic training will be conducted at 30 minutes 3 times a week using brisk walking with target heart rates goals based on percentage of peak HR reserve (HRR= peak-rest HR) during baseline exercise right heart catheterization (RHC). The target HR will progress over the study period from 50% to 70% of peak HR reserve added to resting HR using the standard Karvonen formula (Goal HR = rest HR + target % of HRR). HR will be monitored using Fitbits to guide training intensity with raw data analyzed using the Fitabase platform to monitor compliance |
| Measure | Description | Time Frame |
|---|---|---|
| Change in skeletal muscle O2 diffusive conductance (Dm) during supine cycle exercise | Dm is measured in ml/mm Hg/min during supine cycle exercise | Baseline, approximately 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in peak O2 consumption (peak VO2) during supine cycle exercise | Peak VO2 is measured as milliliters of oxygen per kilogram of body weight per minute (ml/kg/min) during supine cycle exercise. | Baseline, approximately 12 weeks |
| Change in skeletal muscle O2 diffusive conductance (Dm) during single knee-extensor exercise |
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Inclusion Criteria:
Pulmonary Arterial Hypertension (PAH) Subjects:
Healthy Controls:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yogesh Reddy, M.B.B.S | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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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 | May 7, 2026 | Jul 2, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Leg Training | Behavioral | Leg training will be performed using assigned ankle weights to perform knee extension while seated. Initial weight assignment will be guided by a protocol driven in-person exercise tolerance test using varying weights to identify the optimal initial and target training weight for each patient based on the 10 repetition maximum weight identified during this test. Leg training weight will begin at 40% of the baseline 10-repetition maximum weight for weeks 1-4 during which time patients will be required to complete 3 sets of 10 repetitions (30 repetitions total) on 3 days per week. For weeks 4-8, 55% of the initial 10-repetition maximum weight will be used for 4 sets of 10 repetitions (40 repetitions total). For weeks 8-12, 70% of the initial 10-repetition maximum weight will be used for 5 sets of 10 repetitions (50 repetitions total). |
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Dm is measured in ml/mm Hg/min during single knee-extensor exercise. |
| Baseline, approximately 12 weeks |
| Change in maximal mitochondrial respiration | Measured for the respiratory complexes (complex I+II) per mitochondrial protein content (pmol O2/μg mito/sec) from a quadriceps tissue biopsy. | Baseline, approximately 12 weeks |
| Change in Quality of Life as measured by the 36-Item Short-Form Survey (SF-36) | The SF-36 questionnaire measures quality of life through a range of questions asking about patients physical and mental functioning. The SF-36 has a scale of 0-100 with lower scores indicating more disability and lower quality of life. | Baseline, approximately 8 weeks, approximately 12 weeks |
| Change in Quality of Life as measured by the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) questionnaire | PAH-SYMPACT is a PAH-specific patient-reported outcomes instrument that quantifies PAH symptoms and impacts as a measurement of quality of life. The Symptom part is a daily diary that contains 12 items. The respondent is asked to rate each of the items for the past 24 hours. The response options for each item range from 0 " "no [symptom] at all" to 4 "very severe". | Baseline, approximately 8 weeks, approximately 12 weeks |
| Change in Quality of Life as measured by the emPHasis-10 questionnaire | The emPHasis-10 is a short and easy questionnaire that consists of 10 items that address breathlessness, fatigue, control, and confidence. Each item is scored on a semantic differential six-point scale (0-5), with contrasting adjectives at each end. A total emPHasis-10 score is derived using simple aggregation of the 10 items. emPHasis-10 scores range from 0 to 50, higher scores indicate worse quality of life. | Baseline, approximately 8 weeks, approximately 12 weeks |