Home-based High Intensity Functional Strength Training (HIFST) for Older Adults: A Pilot Randomized Controlled Trial of an Exercise Program to Prevent Functional Decline After an Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- Feasibility: Retention
研究概览
简要总结
After an injury, an older adult may experience changes to how they complete their daily activities and participate in physical activity. Changes in how or how often an older adult performs an activity (such as climbing the stairs) can be warning signs of increased future difficulties. The purpose of this study is to prevent this decline by providing an exercise program for older adults experiencing these changes. This pilot study will determine if a 12-week home-based high intensity functional strength training (HIFST) program is feasible for older adults who have had an injury from a slip, trip, or fall. HIFST involves combining periods of performing 'hard' everyday movements to build strength (for example standing and sitting from a chair) with periods of rest or 'easy' activity. Feasibility will be determined based on the amount of recommended exercise sessions people complete, the ability to enroll participants and have them finish the program, as well as demonstration of safety. The study will also measure the effects on physical functioning, cognitive functioning, and enjoyment. Interviews with participants in the HIFST program will be conducted after the 12-weeks to gather information on their experience, opinions, likes/dislikes, and suggestions. All this information will be used to guide a future larger study to determine effectiveness.
详细描述
An injury from a slip, trip or fall in an older adult may instigate the onset of preclinical mobility limitation (PCML) which is a period of time in which modifications in task performance are indicative of an early stage of functional decline. Effective and enjoyable exercise interventions, which may be offered by home-based high-intensity functional strength training (HIFST), are needed during this period. More research is needed on the feasibility of conducting a home-based HIFST in a this group as well it's effects on physical functioning, cognitive functioning and enjoyment. This information, in conjunction with follow-up interviews to asses acceptability, will be used to inform plans of a future fully-powered trial to assess effectiveness.
The primary objective of this trial is to determine the feasibility of 12 weeks of home-based HIFST for community-dwelling older adults who are post-injury as determined by adherence, recruitment, retention, and safety criteria. The secondary objectives are to determine preliminary evidence of effects on physical functioning, cognitive functioning (specifically executive functions and processing speed) and physical activity enjoyment. The investigators will also report any intervention-related adverse events (harms, such as muscle strains, sprains, etc.). The follow-up qualitative study will assess acceptability of the intervention including barriers/facilitators to participation and recommendations for changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
statistical analysis for secondary outcomes
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English-speaking, community-dwelling older adults ≥ 55 years, who
- •sustained an injury from a slip, trip or fall in the last year (assessed by self-report) and
- •as a result report decreased and/or modified daily task performance (assessed using PCML questionnaire based on Mänty) and Participants must have
- •no contraindications to exercise based on the American College for Sports Medicine recommendations and 5) complete the Canadian Society for Exercise Physiology (CSEP) 'Get Active' questionnaire and obtain clearance from a health care professional if deemed necessary based on screening.
- •Participants will be required to have access to email and a laptop/tablet with webcam capable of running the web-based videoconferencing platform Zoom well as 7) the ability to provide informed consent.
排除标准
- •a score of < 11 on the Mini Montreal Cognitive Assessment (Mini MoCa).
结局指标
主要结局
Feasibility: Retention
时间窗: over 12 weeks
Percentage of participants completing baseline and follow-up assessments (criteria: at least 80 percent)
Feasibility: Adherence
时间窗: over 12 weeks (intervention duration)
Percentage of exercise sessions completed (criteria: at least 70 precent)
Feasibility: Safety (number/presence of intervention-related serious adverse events)
时间窗: over 12 weeks (intervention period)
Adverse events related to intervention (criteria: no serious events)
Feasibility: Recruitment
时间窗: 4-6 month recruitment period
Percentage of eligible participants recruited (criteria: at least 65 precent)
次要结局
- Physical Functioning: Two minute step test (TMST)(pre and post intervention (12 weeks))
- Physical Functioning: 30-second chair stand test (30CST)(pre and post intervention (12 weeks))
- Physical Functioning: 4 meter walk test ((pre and post intervention (12 weeks))
- Physical Functioning: dual-task cognitive Timed Up and Go (TUG-COG)(pre and post intervention (12 weeks))
- Physical Functioning: Preclinical Mobility Limitation (PCML) scale(pre and post intervention (12 weeks))
- Cognitive Functioning: California Older Adult Stroop Test (COAST)(pre and post intervention (12 weeks))
- Enjoyment: Physical Activity Enjoyment Scale (PACES)(week 1,2,4,6,8,10,12)
- Cognitive Functioning: Digit Symbol Substitution Test (DSST)(pre and post intervention (12 weeks))
- Cognitive Functioning: Oral Trail Making Test (OTMT)(pre and post intervention (12 weeks))
- Affective response to exercise: Feelings Scale (FS)(week 1,2,4,6,8,10,12)
- Harms(over 12 week intervention period)
研究者
Julie Richardson
Principal Investigator
McMaster University