- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02794415
Evaluating a Community-Based Exercise Intervention With Adults Living With HIV: An Interrupted Time Series Study (CBE)
Translating Exercise Into the HIV Community: Evaluating a Community-based Exercise Intervention to Improve the Health of Adults Living With HIV
연구 개요
상세 설명
Investigators will use the RE-AIM Framework to evaluate the community-based exercise (CBE) intervention. The RE-AIM Framework includes criteria to evaluate the impact and translation of an intervention at both individual and organizational-levels in order to promote uptake, transferability and ultimately enhance the public health impact of health promotion interventions.
Specific study objectives are: 1) To determine the extent (proportion of sessions attended, frequency, intensity, time, type) to which adults with HIV participate in a CBE intervention; 2) To assess the effect of a CBE intervention on disability and health outcomes and intrinsic and extrinsic factor outcomes for people living with HIV; 3) To assess engagement in CBE for adults with HIV over time (adherence, level of physical activity); and 4) To evaluate the process (strengths and challenges; feasibility; accessibility, long term sustainability) of implementing a CBE intervention within the community from the perspective of recreation providers (fitness instructors; managers) and people living with HIV.
Investigators will conduct a prospective longitudinal study using mixed methods to evaluate a CBE intervention in the community with people living with HIV. They will use an interrupted time series (ITS) design in combination with qualitative interviews to assess outcomes at baseline (pre-testing phase), during (intervention phase) and after the CBE intervention (post-testing phase) to evaluate the short- and long-term effect of CBE.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Ontario
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Toronto, Ontario, 캐나다, M5G 1V7
- University of Toronto
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adults (18 years and older) living with HIV in Toronto who consider themselves medically stable and safe to engage in exercise and who are willing to participate in a 22 month study involving a 14 month CBE intervention at the YMCA.
Exclusion Criteria:
- Not applicable.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: Community-based exercise
|
Intervention Phase (6 months): The HIV Community-Based Exercise (CBE) intervention is a 6-month exercise program at the Central Toronto YMCA. Participants will meet the fitness instructor to establish an individualized exercise program that will include a combination of aerobic, resistive, neuromotor and flexibility training. Participants will attend exercise sessions for ~1.5 hour, 3 times per week for 24 weeks. Sessions will be supervised weekly by a fitness instructor. Post-Intervention Phase (8 months): At the end of the 24 week intervention, participants will be encouraged to continue to engage in unsupervised exercise 3 times per week. As per usual practice at the YMCA, a fitness instructor will be available to monitor participants monthly. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Maximum oxygen consumption (VO2max)
기간: Bimonthly outcome assessment throughout baseline monitoring (8 months), intervention (6 months) and follow-up (8 months) for a total of 22 months
|
Maximum oxygen consumption (VO2max) ml/kg/min
|
Bimonthly outcome assessment throughout baseline monitoring (8 months), intervention (6 months) and follow-up (8 months) for a total of 22 months
|
공동 작업자 및 조사자
협력자
간행물 및 유용한 링크
일반 간행물
- O'Brien KK, Bayoumi AM, Solomon P, Tang A, Murzin K, Chan Carusone S, Zobeiry M, Nayar A, Davis AM. Evaluating a community-based exercise intervention with adults living with HIV: protocol for an interrupted time series study. BMJ Open. 2016 Oct 20;6(10):e013618. doi: 10.1136/bmjopen-2016-013618.
- O'Brien KK, Davis AM, Chan Carusone S, Avery L, Tang A, Solomon P, Aubry R, Zobeiry M, Ilic I, Pandovski Z, Bayoumi AM. Examining the impact of a community-based exercise intervention on cardiorespiratory fitness, cardiovascular health, strength, flexibility and physical activity among adults living with HIV: A three-phased intervention study. PLoS One. 2021 Sep 24;16(9):e0257639. doi: 10.1371/journal.pone.0257639. eCollection 2021.
- Solomon P, Carusone SC, Davis AM, Aubry R, O'Brien KK. Experiences of People Living With HIV in Community Based Exercise: A Qualitative Longitudinal Study. J Int Assoc Provid AIDS Care. 2021 Jan-Dec;20:2325958221995344. doi: 10.1177/2325958221995344.
- Solomon P, Chan Carusone S, Davis AM, Aubry R, O'Brien KK. A Qualitative Study of Fitness Coaches' Experiences in Community Based Exercise with People Living with HIV. J Int Assoc Provid AIDS Care. 2021 Jan-Dec;20:23259582211046762. doi: 10.1177/23259582211046762.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
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