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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Kim Kennedy
- 전화번호: 336.713.8567
- 이메일: kimberly.kennedy@advocatehealth.org
연구 장소
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North Carolina
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Winston-Salem, North Carolina, 미국, 27157
- Atrium Health Wake Forest Baptist
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연락하다:
- Kim Kennedy
- 전화번호: 336-713-8567
- 이메일: kimberly.kennedy@advocatehealth.org
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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활성 비교기: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Peak Oxygen Consumption
기간: From baseline to week 8
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Change in peak oxygen consumption (VO2peak) |
From baseline to week 8
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Exercise Dose
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Oxygen Consumption Rate
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Bumsoo Ahn, PhD, Atrium Health Wake Forest Baptist
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- IRB00157231.2
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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