Tackling FRAILTY: ACTIVE-AGE@home: a Home-based Functional Exercise Program for Community Dwelling Frail Older Adults Provided by Professionals and Volunteers.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- The Timed Chair Stand (TCS)
研究概览
简要总结
Despite the high level of evidence for physical activity as a countermeasure for frailty, the current Flemish standard of care does not include structural PA interventions for community-dwelling frail older adults. One barrier for this, is the high cost of supervised physical activity programmes.
Therefore, in this pragmatic randomised controlled trial, the investigators will consider the Flemish current standard of care for frail older adults as a control group. Intervention condition 1 reflects the state-of-the-art physical activity intervention provided by professionals and intervention condition 2 consists of the same intervention provided by trained volunteers. It is hypothesized that the intervention in both intervention conditions will have significant effects on functional ability, cognition, loneliness, self-management, subjective health and meaningful activities and that it can alleviate the financial burden of condition 1 (cost-effectiveness). The pretrajectory of this study was based on the 'British Medical Research Council guidance' for the development and evaluation of complex interventions. This resulted in a comprehensive, state-of-the art personalised physical activity programme for community-dwelling frail older adults: ACTIVE-AGE@home. The programme adheres to current guidelines for physical activity and exercise for frail older adults and considers low threshold and meaningful activities for the participants. The latter perfectly aligns with the complex bio-psychosocial components of frailty. Positive results will help reduce negative outcomes of frailty in older adults and will also reduce health and social expenditures. This study aligns with a 'prevention and health promotion' model.
详细描述
Studies show that physical activity can lower the risk of developing frailty and also reduce frailty-status once it is present. Favorable effects of physical activity on frail older adults include improved muscle strength, aerobic capacity, Quality of Life, cognition, and depression. There is also evidence of a dose response relationship between higher intensities of physical activity and lower levels of frailty. The current body of knowledge proves that physical activity interventions are the best possible (first-choice) treatment to tackle frailty. Despite of this, according to the World Health Organisation, only 7% of frail older adults meet the physical activity guidelines. In scientific literature and previously conducted own research several intrapersonal barriers were detected as a possible explanation for the low participation rates: fear, negative self-esteem, feeling useless, but also environmental barriers: lack of accessibility (location, information, ...) and the absence of a familiar and trustworthy trainers, informal caregivers or volunteers to support the older adults and provide motivation and follow-up.
Rationale for study design:
This study is developed considering the United Nation's 'Decade of Healthy Ageing' and Europe's research agenda on prevention. Therefore, this project fits perfectly with initiatives such as 'Ageing in Place' and 'Societalisation of care'. This project also aligns with the overall framework of the vision on Healthy Ageing of the World Health Organisation (WHO).
Both physical activity and home-based services are reported as part of the top 10 priorities for frailty research by the Canadian Frailty Priority Setting and was co-created with frail older adults. More specifically, RCTs (followed by cost effectiveness studies) focusing on interventions for older adults with frailty are a high priority for the frailty research agenda. Strategies to slow the progression of frailty or convers the frailty state are paramount.
Volunteering:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
A computer algorithm will be used to generate the random allocation sequence. Participants will be randomized in a 1:1 ratio, using permuted block randomization into one of the three parallel groups. Randomization will be done centrally by an interactive web response system. Once the participants are found eligible for the trial, they can be randomized. This will generate a unique study randomization number and the treatment arm label (A professionals, B volunteers, C control) to which the participant is randomized. An accountability log with the corresponding label will be kept by the PI or delegated person to ensure that allocation was successfully performed. Participants will be scheduled to receive their randomisation within one week of eligibility assessment.
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>70 years adults
- •Frail according to the frailty phenotype of Fried, defining frailty as the presence of 3 or more of the following 5 criteria: unintentional weight loss, weakness, exhaustion (low energy level), slowness (slow gait) and low physical activity
排除标准
- •life expectancy less than 12 months by any cause
- •oncologic participants with active treatment
- •treatment with exercise therapy in the preceding 6 months
- •any contra-indication for exercise therapy as established by the treating physician/family practitioner
- •cognitive impairment (unable to understand the test instructions and/or Mini Mental State Examination score <23/30)
- •unable to understand the Dutch language
- •diagnosed with Parkinson or Multiple Sclerosis
- •having had a stroke in the preceding 6 months" to the registry
研究组 & 干预措施
ACTIVE-AGE@home by professionals
Training program of 24 weeks supervised by professionals with a relevant background in the treatment and/or training of the older adults.
The older adults are trained by either a physiotherapist, an occupational therapist or an exercise professional. The professionals will receive a 3x4h training course to gain more knowledge and practice regarding following aspects:
- Frailty and ageing.
- Physical training principles + ACTIVE-AGE@home exercise program
- Motivational coaching.
All participants in the three arms will receive the same monthly newsletter with tips and tricks to obtain good health in older age.
干预措施: ACTIVE-AGE@home (Behavioral)
ACTIVE-AGE@home by volunteers
Training program of 24 weeks supervised by volunteers who are presented by the older adults themselves or who are recruited by the research group.
The older adults are trained by an informal caregiver or a newly recruited volunteer. The informal caregivers and volunteers will receive a 3x4h training course to gain more knowledge and practice regarding following aspects:
- Frailty and ageing.
- Physical training principles + ACTIVE-AGE@home exercise program
- Motivational coaching.
All participants in the three arms will receive the same monthly newsletter with tips and tricks to obtain good health in older age.
干预措施: ACTIVE-AGE@home (Behavioral)
Standard care for frail older adults
The two intervention conditions will be compared with the current standard care for frail community-dwelling elderly that does not include physical activity interventions.
All participants in the three arms will receive the same monthly newsletter with tips and tricks to obtain good health in older age.
结局指标
主要结局
The Timed Chair Stand (TCS)
时间窗: T2 = 48 weeks, follow up measurement
The timed chair rise (TCR) is one of the most important functional evaluation clinical tests because it measures physical lower body strength and relates it to the most demanding ADLs (e.g., climbing stairs, getting out of a chair or bathtub, or rising from a horizontal position). This test is chosen based on literature data and consultancy of the experts of the research consortium. The TCR is considered a 'stress test', i.e., a test that aims to challenge the maximal physiological and/or physical capacity of the participant. It is responsive to change and influenceable via physical activity interventions, including ACTIVE-AGE@home. The test is also proven valid and reliable. In the TCR assessment, patients are asked to stand upright from a seated position in a chair (height 43 cm) with their arms folded across their chest and return to a seated position as many times as possible within a 30-s period.
The Timed Chair Stand (TCS)
时间窗: T0 = 0 weeks, prior to start of exercise program
The timed chair rise (TCS) is one of the most important functional evaluation clinical tests because it measures physical lower body strength and relates it to the most demanding ADLs (e.g., climbing stairs, getting out of a chair or bathtub, or rising from a horizontal position). This test is chosen based on literature data and consultancy of the experts of the research consortium. The TCR is considered a 'stress test', i.e., a test that aims to challenge the maximal physiological and/or physical capacity of the participant. It is responsive to change and influenceable via physical activity interventions, including ACTIVE-AGE@home. The test is also proven valid and reliable. In the TCR assessment, patients are asked to stand upright from a seated position in a chair (height 43 cm) with their arms folded across their chest and return to a seated position as many times as possible within a 30-s period.
The Timed Chair Stand (TCS)
时间窗: T1 = 24 weeks, at the end of the exercise program
The timed chair rise (TCS) is one of the most important functional evaluation clinical tests because it measures physical lower body strength and relates it to the most demanding ADLs (e.g., climbing stairs, getting out of a chair or bathtub, or rising from a horizontal position). This test is chosen based on literature data and consultancy of the experts of the research consortium. The TCR is considered a 'stress test', i.e., a test that aims to challenge the maximal physiological and/or physical capacity of the participant. It is responsive to change and influenceable via physical activity interventions, including ACTIVE-AGE@home. The test is also proven valid and reliable. In the TCR assessment, patients are asked to stand upright from a seated position in a chair (height 43 cm) with their arms folded across their chest and return to a seated position as many times as possible within a 30-s period.
次要结局
- Two Minute Step Test (TMST)(T2 = 48 weeks, follow up measurement)
- The Timed Up and Go Test(T2 = 48 weeks, follow up measurement)
- MOS 36-item-short-form health survey (SF-36)(T2 = 48 weeks, follow up measurement)
- iMTA Medical Consumption Questionnaire (iMCQ)(T2 = 48 weeks, follow up measurement)
- Fatigue resistance grip strength test(T2 = 48 weeks, follow up measurement)
- MOCA Montreal Cognitive Assessment(T2 = 48 weeks, follow up measurement)
- Trail making test(T2 = 48 weeks, follow up measurement)
- Rey Auditory Verbal Learning Test(T2 = 48 weeks, follow up measurement)
- De Jong Gierveld 11-item loneliness scale(T2 = 48 weeks, follow up measurement)
- Engagement in meaningful activities scale(T2 = 48 weeks, follow up measurement)
- Self-Management Abilities Scale - Short Form2(T2 = 48 weeks, follow up measurement)
- Activities of Daily Life (National Health Interview Survey) (HIS)(T2 = 48 weeks, follow up measurement)
- MOCA Montreal Cognitive Assessment(T0 = 0 weeks, prior to start of exercise program)
- Two Minute Step Test (TMST)(T0 = 0 weeks, prior to start of exercise program)
- Two Minute Step Test (TMST)(T1 = 24 weeks, at the end of the exercise program)
- The Timed Up and Go Test(T0 = 0 weeks, prior to start of exercise program)
- The Timed Up and Go Test(T1 = 24 weeks, at the end of the exercise program)
- MOS 36-item-short-form health survey (SF-36)(T0 = 0 weeks, prior to start of exercise program)
- MOS 36-item-short-form health survey (SF-36)(T1 = 24 weeks, at the end of the exercise program)
- iMTA Medical Consumption Questionnaire (iMCQ)(T0 = 0 weeks, prior to start of exercise program)
- iMTA Medical Consumption Questionnaire (iMCQ)(T1 = 24 weeks, at the end of the exercise program)
- MOCA Montreal Cognitive Assessment(T1 = 24 weeks, at the end of the exercise program)
- Trail making test(T0 = 0 weeks, prior to start of exercise program)
- Trail making test(T1 = 24 weeks, at the end of the exercise program)
- Rey Auditory Verbal Learning Test(T0 = 0 weeks, prior to start of exercise program)
- Rey Auditory Verbal Learning Test(T1 = 24 weeks, at the end of the exercise program)
- De Jong Gierveld 11-item loneliness scale(T0 = 0 weeks, prior to start of exercise program)
- De Jong Gierveld 11-item loneliness scale(T1 = 24 weeks, at the end of the exercise program)
- Engagement in meaningful activities scale(T0 = 0 weeks, prior to start of exercise program)
- Engagement in meaningful activities scale(T1 = 24 weeks, at the end of the exercise program)
- Self-Management Abilities Scale - Short Form2(T0 = 0 weeks, prior to start of exercise program)
- Self-Management Abilities Scale - Short Form2(T1 = 24 weeks, at the end of the exercise program)
- Fatigue resistance grip strength test(T0 = 0 weeks, prior to start of exercise program)
- Fatigue resistance grip strength test(T1 = 24 weeks, at the end of the exercise program)
- Activities of Daily Life (National Health Interview Survey) (HIS)(T0 = 0 weeks, prior to start of exercise program)
- Activities of Daily Life (National Health Interview Survey) (HIS)(T1 = 24 weeks, at the end of the exercise program)
研究者
Patricia De Vriendt
Prof dr
Vrije Universiteit Brussel