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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
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
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).
Mayo Clinic in Rochester
Rochester, Minnesota, United States
RECRUITINGChange in skeletal muscle O2 diffusive conductance (Dm) during supine cycle exercise
Dm is measured in ml/mm Hg/min during supine cycle exercise
Time frame: Baseline, approximately 12 weeks
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.
Time frame: Baseline, approximately 12 weeks
Change in skeletal muscle O2 diffusive conductance (Dm) during single knee-extensor exercise
Dm is measured in ml/mm Hg/min during single knee-extensor exercise.
Time frame: 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.
Time frame: 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.
Time frame: 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".
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Time frame: 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.
Time frame: Baseline, approximately 8 weeks, approximately 12 weeks