Wearable Robotics to Overcome Exercise Dose Limitations in Older Adults - Study 2
Wearable Robotics to Overcome Exercise Dose Limitations in Older Adults
The purpose of this research is to learn whether a lightweight wearable robotic device called We Innovate Mobility (WIM) can improve exercise capacity and physical function for older adults.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Study 2 is an open-label, randomized, parallel-group controlled pilot trial. Participants will be randomized in a 1:1 ratio to eight weeks of supervised We Innovate Mobility (WIM)-assisted treadmill walking or conventional treadmill walking. Exercise intensity will be prescribed using a target of 70% heart rate reserve, with speed and grade adjusted to maintain walking intensity. Outcomes will be assessed before and after the intervention.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Kim Kennedy
- Numéro de téléphone: 336.713.8567
- E-mail: kimberly.kennedy@advocatehealth.org
Lieux d'étude
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North Carolina
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Winston-Salem, North Carolina, États-Unis, 27157
- Atrium Health Wake Forest Baptist
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Contact:
- Kim Kennedy
- Numéro de téléphone: 336-713-8567
- E-mail: kimberly.kennedy@advocatehealth.org
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Community-dwelling adult aged ≥65 years
- Able to safely wear and use the WIM device
- Willing to complete conventional and WIM-assisted treadmill walking
- Able to provide informed consent and comply with study procedures
- Able to provide informed consent and comply with study procedures
Exclusion Criteria:
- Recent hospitalization, surgery, fracture, or other medical condition that limits safe treadmill walking
- Resting blood pressure, heart rate, or symptoms that meet protocol-defined safety exclusion criteria before exercise
- Requires a cane, walker, or other assistive device for ambulation
- Regular participation in structured aerobic exercise
- Any condition judged by the study clinician to make participation unsafe or interfere with study procedures
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: We Innovate Mobility (WIM)-Assisted Treadmill Walking
participants will walk on treadmill with assistance from the We Innovate Mobility (WIM) device |
We Innovate Mobility (WIM) is an externally worn, powered device that provides temporary mechanical assistance during voluntary walking. Participants will walk on the treadmill three times per week for eight weeks while wearing the device. |
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Comparateur actif: Conventional Treadmill Walking
participants will walk on treadmill without assistance from the We Innovate Mobility (WIM) device |
Participants will walk on the treadmill three times per week for eight weeks without assistance from the We Innovate Mobility (WIM) device. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Peak Oxygen Consumption
Délai: From baseline to week 8
|
Change in peak oxygen consumption (VO2peak) |
From baseline to week 8
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Exercise Dose
Délai: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
|
Exercise dose is defined was walking duration x average treadmill speed x average treadmill grade |
Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
|
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400 Meter Walk Time
Délai: Baseline and Week 8
|
Participants will be instructed to walk 400 meters at their usual fast pace without running, with standardized encouragement provided throughout the test. Participants will be permitted to slow down or rest briefly if needed for safety. Total completion time recorded. Participants will be permitted to slow down or rest briefly if needed for safety. |
Baseline and Week 8
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Expanded Short Physical Performance Battery (eSPPB)
Délai: Baseline and Week 8
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eSPPB consists of 5 repeated chair stands, standing balance (semi- and full-tandem stands and a single leg stand for 30 seconds), a 6-meter walk to assess usual gait speed, and a narrow 6-meter walk test of balance (walking at usual pace within lines of tape spaced 20 cm apart). Total score range is 0-4 with a higher score indicating better performance. |
Baseline and Week 8
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PROMIS Fatigue Short Form 7a Survey
Délai: Baseline and Week 8
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PROMIS Fatigue Short Form 7a measures the severity and functional impact of fatigue on everyday functioning. Total score range is 7-35 with a higher score indicating a higher level of fatigue. |
Baseline and Week 8
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Pittsburgh Fatigability Scale
Délai: Baseline and Week 8
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Activity-related fatigability will be assessed using the Pittsburgh Fatigability Scale which evaluates perceived physical fatigue in response to standardized daily activities of defined intensity and duration. Total score range is 0-50 with higher numbers representing greater perceived fatigability. |
Baseline and Week 8
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Oxygen Consumption Rate
Délai: Baseline and Week 8
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Oxygen consumption rate of the peripheral blood mononuclear cells (PBMC) cells measured using respirometry. |
Baseline and Week 8
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Bumsoo Ahn, PhD, Atrium Health Wake Forest Baptist
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
Autres numéros d'identification d'étude
- IRB00157231.2
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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.
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