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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Kim Kennedy
- Numero di telefono: 336.713.8567
- Email: kimberly.kennedy@advocatehealth.org
Luoghi di studio
-
-
North Carolina
-
Winston-Salem, North Carolina, Stati Uniti, 27157
- Atrium Health Wake Forest Baptist
-
Contatto:
- Kim Kennedy
- Numero di telefono: 336-713-8567
- Email: kimberly.kennedy@advocatehealth.org
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
|
Comparatore attivo: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Peak Oxygen Consumption
Lasso di tempo: From baseline to week 8
|
Change in peak oxygen consumption (VO2peak) |
From baseline to week 8
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Exercise Dose
Lasso di tempo: 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
|
|
400 Meter Walk Time
Lasso di tempo: 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
|
|
Expanded Short Physical Performance Battery (eSPPB)
Lasso di tempo: Baseline and Week 8
|
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
|
|
PROMIS Fatigue Short Form 7a Survey
Lasso di tempo: Baseline and Week 8
|
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
|
|
Pittsburgh Fatigability Scale
Lasso di tempo: Baseline and Week 8
|
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
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Oxygen Consumption Rate
Lasso di tempo: Baseline and Week 8
|
Oxygen consumption rate of the peripheral blood mononuclear cells (PBMC) cells measured using respirometry. |
Baseline and Week 8
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Bumsoo Ahn, PhD, Atrium Health Wake Forest Baptist
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- IRB00157231.2
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .