- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07928687
Feasibility Study of an Outdoor Strength Training Program for Older Adults
Development and Implementation of Resistance Training Programs in Community-dwelling Older Adults Using Outdoor Activity Benches: a Feasibility and Pilot Study.
In order to promote healthy ageing and independent living, the World Health Organization recommends older adults to engage in resistance exercise at least twice weekly. However, only a minority of the older population complies with these guidelines, stressing the urgent need to develop comprehensive strategies to implement resistance exercise programs in the community. This PhD project will be performed in close collaboration with IPitup vzw, who developed outdoor activity benches, an accommodating smartphone app with exercise instructions and training courses as a low-cost modality for resistance exercise in the general population. The aim is to build upon these existing structures and develop an optimized, progressive resistance exercise program for community-dwelling older adults, which can be performed in small groups without the need for specialized training experts. The program's feasibility, defined in terms of safety, adherence, usability and acceptability, will be tested.
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Prof. Christophe Delecluse
- 전화번호: +32 16 32 90 76
- 이메일: christophe.delecluse@kuleuven.be
연구 연락처 백업
- 이름: Lien Valepyn
- 전화번호: +32 488 84 85 97
- 이메일: lien.valepyn@kuleuven.be
연구 장소
-
-
Vlaams-Brabant
-
Leuven, Vlaams-Brabant, 벨기에, 3000
- 모병
- KU Leuven - Department of Movement Sciences
-
연락하다:
- Prof. Christophe Delecluse
- 전화번호: +32 16 32 90 76
- 이메일: christophe.delecluse@kuleuven.be
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Community-dwelling adults
- At least 65 years old
Exclusion Criteria:
- Participation in an interventional study with an investigational medicinal product (IMP) or device
- Systematic engagement in resistance exercise during the past year
- Self-reported, unstable cardiovascular disease, neuromuscular disease, acute infection or fever
- Self-reported, surgery in the past year
- Self-reported injuries that result in the inability to perform study-related tasks
- Inability to understand the test and training procedures because of cognitive problems
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Peer-supported outdoor strength training
Participants take part in a 6-week outdoor strength training program using activity benches and a smartphone application. Training is performed in small groups of six community-dwelling older adults. Within each group, one participant acts as a peer coach and provides practical support and motivation. |
2x/week, 35-45min sessions at the outdoor activity bench |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants Experiencing Adverse Events
기간: Throughout the 6-week intervention
|
Safety of the intervention, assessed as the number of participants experiencing one or more adverse events related to testing or training sessions during the intervention period. |
Throughout the 6-week intervention
|
|
Participant Adherence Rate
기간: Throughout the 10-week study period
|
Adherence to the intervention, assessed as the proportion of participants who complete the intervention and post-intervention assessments. And assessed as the percentage of scheduled training sessions attended by participants during the 6-week intervention. |
Throughout the 10-week study period
|
|
System Usability Scale (SUS)
기간: Post-intervention at week 9
|
Usability of the intervention will be assessed using the System Usability Scale (SUS), a 10-item questionnaire yielding a total score ranging from 0 to 5. Five items are positively worded, for which higher response scores indicate greater usability, while five items are negatively worded and are reverse-scored, such that lower response scores indicate greater usability. |
Post-intervention at week 9
|
|
Net Promoter Score (NPS)
기간: Post-intervention at week 9
|
Acceptability of the intervention, assessed using the Net Promoter Score (NPS), based on participants' likelihood of recommending the programme to others. Scores range from 0 to 10, with higher scores indicating greater acceptability and willingness to recommend the intervention. |
Post-intervention at week 9
|
|
Participant Acceptability of the Intervention
기간: Post-intervention at week 9
|
Acceptability of the intervention, assessed through participant feedback regarding the peer-led delivery model and the appropriateness of training intensity and progression. Responses will be summarized descriptively. |
Post-intervention at week 9
|
|
Completion Rate of Data Collection Procedures
기간: Over the 10-week study period
|
Feasibility of data collection procedures, assessed as the proportion of planned laboratory-based assessments, questionnaire assessments, and IPitup app-based assessments successfully completed by participants. Higher percentages indicate greater feasibility of the data collection procedures. |
Over the 10-week study period
|
|
Change in Lower Limb Muscle Strength and Power
기간: Baseline at week 1 and post-intervention at week 9
|
Preliminary effects of the intervention on muscle strength and power, assessed as the change in lower limb muscle strength and power from baseline to post-intervention. Muscle strength and power will be measured using the predefined study strength assessment protocol. Higher values indicate greater muscle strength and power. |
Baseline at week 1 and post-intervention at week 9
|
|
Implementation Barriers and Facilitators Identified During Focus Groups
기간: Post-intervention at week 10
|
Implementation barriers and facilitators will be explored through semi-structured focus groups conducted following the intervention. Audio recordings will be transcribed verbatim and analysed using qualitative thematic analysis. Identified barriers and facilitators will be categorized into themes to inform optimization of a future randomized controlled trial. |
Post-intervention at week 10
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
- S71971
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .