Understanding the Effects of Pulmonary Arterial Hypertension on Lean Muscle Mass-Substudy (MUSCLE-UPSUB)
Understanding the Effects of Pulmonary Arterial Hypertension on Lean Muscle Mass-Penn Pilot Low Load Resistance Exercise Training Substudy
Aperçu de l'étude
Statut
Les conditions
Description détaillée
After obtaining informed consent, patients will be scheduled for an in-person substudy baseline visit. The subject will have their vital signs checked, will complete the E10 questionnaire, have blood drawn, and will complete exercise testing:
an occlusion device (Kaatsu B2 model) will be applied to the thigh area and a wireless NIRS device (PortaMon, Artinis, The Netherlands) will be applied over their right gastrocnemius muscle and secured with strap. The participant will be seated in a chair and allowed to rest for up to 10 minutes, and then the participant will begin performing seated heel raises. Once comfortable with the maneuver, the occlusion device will be inflated to systolic blood pressure (SBP) + 50 mmHg for 5 minutes and the participant will be asked to resume the seated heel raises. Then the cuff will be deflated at the completion of the 5 minutes. This will be followed by a 10-minute rest period and then repeated (cuff inflation and exercises for another 5 minutes). The occlusion device will then be removed, and the patient will continue wearing the NIRS in the seated position for another 20 minutes to capture the recovery phase.
A post-exercise blood draw will completed during the recovery phase.
A certified exercise physiologist will demonstrate the at-home exercises to the participant and assess their strength level and observe them performing them ensuring proper form and technique. Each exercise will be performed in 3 sets of 15-15-15 repetitions. A handout will be given to the participant to be used as a resource during the 12 +/- 1 week period between visits.
Low-load resistance training exercises:
Seated heel raises: Starting from seated position in a chair, the participant will place both their feet on the floor. Next they will press down with the forefoot and toes to raise their heels up off the floor. Then, they will lower their heels back down and repeat. They will be asked to keep their toes down on the floor the entire time.
Depending on the participant's strength, this exercise will be upgraded to seated heel raises with resistance. Participant will be in seated position on chair and will have a weight placed on their thigh comfortably. Then heel raises will be performed as described above.
The next upgrade to this exercise will be standing double heel raises: Participants will be asked to stand near a wall/counter for balance support as needed. The participant will lift up onto the balls of their feet and then slowly lower their heels back to ground and repeat as needed.
The next upgrade to this exercise will be standing single heel raises: Participants will be asked to stand near a wall/counter for balance support as needed. The participant will lift one leg up, bending at the knee then lift up onto the ball of their foot that's on the ground. The participant will then slowly lower their heel back to the ground and repeat as needed.
Plantar flexion: While sitting on the floor or a mat, the participant will place the band around the ball of their foot and toes and pull back until they feel a gentle stretch. The participant will press down on the band using their ankles but keeping their toes relaxed. Then the participant will press down fully with the toes. To release let the band, the participant will pull the toes up first before releasing the ankle back to start. The band resistance will be upgraded as the participant progresses.
Sit to stand: The participant will start by scooting close to the front of the chair. Next, they will lean forward at their trunk and reach forward with their arms and rise to standing without using their hands to push off from the chair or other object. The participant will use their arms as a counter-balance by reaching forward when in sitting and lowering them as they approach standing.
Depending on patient's progress, this will be upgraded to box squats: with hands out in front of the participant, they will bend forwards at the hips, like they are going to sit back on a chair (get their hips as far away from their ankles as they can) and then return to standing. The participant will not sit; just tap the box with their bum. The participant will use the box or chair below as a target to hit as they squat down.
The next upgrade will be to loaded sit to stands: With the participant sitting on a sturdy chair and holding onto a medicine ball, or a weight, they will keep the weight close to the body. Keeping their back straight, the participant will lean forward at the hips (hip hinge) to get their weight over their feet. Then the participant will stand all the way up tall and make sure to keep their abdominals drawn in during the task.
Once each participant feels comfortable in performing the exercises independently, they will be provided with the resistance bands to go home. Each participant will be instructed to perform these exercises 3 times per week at their discretion and to log their completion in the exercise diary. The participant will then be scheduled for a follow-up visit mirroring the baseline visit at 12-weeks +/- 1 week. At the 12-week visit, the participant will also complete the E10 questionnaire and that will conclude their substudy participation.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Nicole Denney, MS
- Numéro de téléphone: 215-615-4156
- E-mail: nicole.denney@pennmedicine.upenn.edu
Sauvegarde des contacts de l'étude
- Nom: Rebecca Gallagher Research Project Manager, MSEd
- Numéro de téléphone: 215-662-4088
- E-mail: rebecca.lang@pennmedicine.upenn.edu
Lieux d'étude
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, États-Unis, 19104
- University of Pennsylvania Hospital
-
Contact:
- Nicole Denney, MS
- Numéro de téléphone: 215-294-9755
- E-mail: Nicole.denney@Pennmedicine.upenn.edu
-
Chercheur principal:
- Nadine Al-Namaani, MD
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria: Participating the main MUSCLE UP Study:
- Signed informed consent prior to initiation of any study mandated procedure.
- Male and female patient's ≥ 18 years of age.
- Diagnosis of PAH belonging to one of the following subgroups of Group 1 PH according to the updated clinical classification [Humbert 2022]
- Idiopathic (IPAH)
- Heritable (HPAH)
- Drugs or toxins induced
- Associated (APAH) with one of the following:
- Connective tissue disease;
- Human immunodeficiency virus (HIV) infection;
- Congenital heart disease; or
- Portopulmonary hypertension
- Diagnosis of PAH within 6 months of enrollment or diagnosis of PAH and on stable therapy for 3 months prior to enrollment
- Documented hemodynamic diagnosis of PAH by right heart catheterization (RHC), prior to enrollment showing:
- mPAP > 20 mmHg; and
- PAWP or LVEDP ≤ 15 mmHg
- PVR > 2 Wood units
Exclusion Criteria:
- Prior to enrollment, evidence of moderately severe obstructive ventilator defect with:
- FEV1/FVC ≤ 5th percentile; and
- FEV1 z-score < -2.5
- Prior to enrollment, evidence of severe restrictive defect with
- TLC < 5th percentile
- FEV1 z-score < -4
- More than moderate aortic or mitral valve disease
- LVEF < 40% within 1 year of screening
- Pregnancy
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: Low resistance exercise intervention
Participants will be asked to perform a series of exercises recommend by the National Institute on Aging Go4Life campaign, namely seated heel raise, plantar flexion, sit to stand, and box squats.
They will wear the portamon device to measure muscle oxygenation and have blood drawn to measure adiponectin before performing the above exercises at home for 12 weeks, and then be measured with the portamon device and undergo another flood draw again after 12 weeks.
|
: The investigators will measure oxy-hemoglobin and deoxyhemoglobin concentration using NIRS applied to the biceps and calf pre- and post- exercise at baseline and Week 12.
Moreover, the investigators will measure time to recovery of oxy-hemglobin post-exercise at baseline and at Week 12. Time Frame: 12 weeks
Autres noms:
: The investigators will measure adiponectin levels using a solid phase sandwich ELISA (R&D Systems, Inc., Minneapolis, MN) with a minimum detectable dose of 0.246 ng/mL and intra-assay variations (CV) 2.5%-4.7%.Time Frame: 12 Weeks
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Difference in circulating level of adiponectin (ng/mL) pre- and post-exercise at baseline and at Week 12
Délai: 12 Weeks
|
The investigators will measure adiponectin levels using a solid phase sandwich ELISA (R&D Systems, Inc., Minneapolis, MN) with a minimum detectable dose of 0.246 ng/mL and intra-assay variations (CV) 2.5%-4.7%.
|
12 Weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Measurement of deoxyhemoglobin concentration pre and post-exercise at baseline and Week 12.
Délai: 12 weeks
|
The investigators will measure deoxyhemoglobin concentration using NIRS applied to the calf pre- and post-exercise at baseline and Week 12.
|
12 weeks
|
|
Measurement of oxyhemoglobin recovery post exercise at Baseline and Week 12
Délai: 12 weeks
|
The investigators will measure the time to recovery of oxyhemoglobin concentration post-exercise using NIRS applied to the calf at baseline and Week 12.
|
12 weeks
|
|
Measurement of oxyhemoglobin concentration pre and post- exercise at baseline and Week 12.
Délai: 12 weeks
|
The investigators will measure oxy-hemoglobin concentration using NIRS applied to the calf pre- and post- exercise at baseline and Week 12.
|
12 weeks
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Nadine Al-Namaani, MD, University of Pennsylvania
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies des voies respiratoires
- Maladies pulmonaires
- Hypertension pulmonaire
- Comportement
- Hypertension artérielle pulmonaire
- Activité motrice
- Techniques d'investigation
- Manipulation des échantillons
- Techniques de laboratoire clinique
- Techniques et procédures de diagnostic
- Diagnostic
- Perforation
- Procédures chirurgicales, opératoires
- Collection d'échantillons de sang
Autres numéros d'identification d'étude
- 856202 Substudy
- R01HL173533 (Subvention/contrat des NIH des États-Unis)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .