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临床试验/NCT07817914
NCT07817914已完成不适用

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

University in Zielona Góra1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年10月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Feasibility of the Exercise Program (proportion (%) of participants meeting the described feasibility criteria across 4 domains: adherence, retention, tolerability, and safety)

研究概览

简要总结

This pilot study will evaluate whether a short, self-regulated interval exercise program is practical and safe for adults aged 60 and older. The program consists of short periods of running or walking in place, with rest periods between exercises, and allows participants to adjust the intensity to their individual abilities. The findings will help determine whether this type of exercise program is suitable for further research in larger studies.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age between 60-80 years
  • written consent to participate in the study

排除标准

  • 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

研究组 & 干预措施

Running Interval Training

Experimental

干预措施: Running Interval Training (Behavioral)

结局指标

主要结局

Feasibility of the Exercise Program (proportion (%) of participants meeting the described feasibility criteria across 4 domains: adherence, retention, tolerability, and safety)

时间窗: From baseline through post-intervention assessment following the 4-week intervention period

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.

次要结局

未报告次要终点

研究者

发起方
University in Zielona Góra
申办方类型
Other
责任方
Principal Investigator
主要研究者

Franciszek Pietraszkiewicz

Principal Investigator

University in Zielona Góra

研究点 (1)

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