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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Kim Kennedy
- Telefonnummer: 336.713.8567
- E-post: kimberly.kennedy@advocatehealth.org
Studiesteder
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North Carolina
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Winston-Salem, North Carolina, Forente stater, 27157
- Atrium Health Wake Forest Baptist
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Ta kontakt med:
- Kim Kennedy
- Telefonnummer: 336-713-8567
- E-post: kimberly.kennedy@advocatehealth.org
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Aktiv komparator: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Peak Oxygen Consumption
Tidsramme: From baseline to week 8
|
Change in peak oxygen consumption (VO2peak) |
From baseline to week 8
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Exercise Dose
Tidsramme: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
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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
Tidsramme: Baseline and Week 8
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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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Oxygen Consumption Rate
Tidsramme: 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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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Bumsoo Ahn, PhD, Atrium Health Wake Forest Baptist
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- IRB00157231.2
Plan for individuelle deltakerdata (IPD)
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