- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07817914
Feasibility of an Interval Running Exercise Program With Self-Regulated Unloading in Adults Aged 60 and Older
Feasibility and Preliminary Effects of an Exercise Model Based on Running Interval Training With Self-Regulated Unloading on Body Composition, Physical Fitness and Exercise Capacity, Muscle Strength, Pain Level, and Fall Risk in Adults Aged 60 and Older
연구 개요
상세 설명
Regular physical activity is important for maintaining health and physical function in older adults. However, conventional exercise programs may be difficult to perform because of limited mobility, joint pain, concerns about injury, or other individual barriers. Short bouts of exercise combined with individually regulated joint unloading may provide a practical and adaptable approach for older adults. This pilot feasibility study will evaluate a novel self-regulated interval exercise program designed for adults aged 60 to 80 years. The program is inspired by the concepts of high-intensity interval training (HIIT) and exercise snacks, but is adapted to the individual physical abilities of older adults.
The intervention will last 4 weeks. Assessments will include adherence and adverse events monitoring, body composition analysis by a bioelectrical impedance method, lower-extremity muscle strength assessment using the five times sit to stand test (FTSST), aerobic capacity assessment by 2-minute step in place test (2MST), pain intensity assessment using numerical rating scale (NRS), and fall risk assessment using timed up & go test (TUG).
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Lubusz Voivodeship
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Nowa Sól, Lubusz Voivodeship, 폴란드, 67-100
- Wielospecjalistyczny Szpital Samodzielny Publiczny Zakład Opieki Zdrowotnej w Nowej Soli
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- age between 60-80 years
- written consent to participate in the study
Exclusion Criteria:
- unstable angina
- circulatory and respiratory failure
- implanted metal materials (e.g. defibrillator, pacemaker, stent)
- a mental disorder that makes it difficult to cooperate with medical personnel
- inability to safely perform exercise at an exertion corresponding to rating of perceived exertion (RPE) ≥ 14 on the 6-20 Borg scale
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Running Interval Training
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The intervention will last 4 weeks.
Participants will perform four exercise sessions each day.
Each session will consist of five 1-minute periods of running or walking in place, separated by 20-second rest periods.
Gymnastic sticks will be used to allow participants to regulate the amount of weight placed through the lower extremities.
Participants will be able to increase or decrease the amount of support provided by the sticks according to their individual needs and comfort, thereby self-regulating the unloading of the lower-extremity joints.
The target exercise intensity corresponds to rating of perceived exertion (RPE) ≥ 14 on the 6-20 Borg scale
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Feasibility of the Exercise Program (proportion (%) of participants meeting the described feasibility criteria across 4 domains: adherence, retention, tolerability, and safety)
기간: From baseline through post-intervention assessment following the 4-week intervention period
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Feasibility will be assessed as the proportion (%) of participants meeting the following feasibility criteria across 4 domains: adherence, retention, tolerability, and safety.
Adherence: % of participants completing ≥75% of prescribed training days (weekly training recordings).
Green ≥75%, amber 50-74%, red <50%.
Retention: % completing intervention and post-assessment.
Green ≥80%, amber 60-79%, red <60%.
Tolerability: % with worsening in strength (Five Times Sit-to-Stand Test), aerobic capacity (2-Minute Step Test), or pain (Numeric Rating Scale).
Green ≤20%, amber 20-30%, red >30%.
Safety: % reporting minor adverse events and number of serious adverse events (SAE) (medical records).
Green <10% and no related SAE; amber 10-40% and no related SAE; red >40% or any related SAE.
Overall feasibility: all domains green = feasible without modification; any amber with no red = feasible after modification; any red = not feasible and requires major modification and further feasibility testing.
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From baseline through post-intervention assessment following the 4-week intervention period
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공동 작업자 및 조사자
수사관
- 수석 연구원: Franciszek Pietraszkiewicz, University of Zielona Góra
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 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- UZ/0015.37/2024
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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