A Model for Delivering Strength Training and Nutrition Education for Older Adults (MoveStrong): A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 9
- 主要终点
- Feasibility - Recruitment
研究概览
简要总结
There is strong evidence that specific types of exercise can improve health and physical function in older adults. While community exercise classes exist, many older adults with chronic conditions may need guidance from credentialed exercise professionals to ensure sufficient dose and progression and to address fears or low exercise self-efficacy. Furthermore, low protein intake among older adults is common and initiating exercise when nutrition is inadequate may cause weight loss and limit gains in muscle strength. The primary goal is to determine the feasibility of implementing the MoveSTroNg program under real-world conditions, measured through referral and recruitment to the program and study retention and adherence rates.
详细描述
The MoveStrong trial is a 1-year pilot closed cohort stepped wedge randomized control trial (RCT) to evaluate the feasibility of implementation of the MoveStrong program. This program includes a functional exercise and nutrition program that teaches older adults with chronic diseases how to perform functional resistance and balance exercises and promote adequate protein intake and nutrition. Four sites (1 Northern and 3 Southern Ontario sites) will be cluster-randomized to implement MoveStrong at one of four start times, each three weeks apart. The primary outcome will be to determine the feasibility of recruitment and referral from diverse settings (i.e., retirement homes, community centers, and family health teams) and establish the retention and adherence to the program. Secondary objectives will determine the following: What are the participant's and provider's experience with the MoveStrong program? What is the short-term responsiveness (i.e., ability to detect change) of frailty indicators (Fried Frailty Index components), protein intake, or quality of life? Who agrees to participate? What adaptations need to be made to MoveStrong, or study methods in each setting? What is the cost relative to the benefit? Is behaviour change maintained in the maintenance period? Our long term goal is to use the information from this project to develop, implement, and evaluate a sustainable, scalable and pragmatic model to deliver strength and balance training and promote adequate protein intake among older adults with chronic diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Speak English or attend with a translator;
- •≥ 60 years;
- •FRAIL scale score ≥1;
- •Have ≥1 diagnosed chronic condition (i.e., diabetes, obesity, cancer (other than minor skin cancer), chronic lung disease, cardiovascular disease, congestive heart failure, hypertension, osteoporosis, arthritis, stroke, or kidney disease).
排除标准
- •Currently doing similar resistance exercise ≥2x/week;
- •In palliative care;
- •Not able to perform basic activities of daily living;
- •Cognitive impairment (e.g., unable to follow two-step commands);
- •Travelling >1 week during exposure;
- •Absolute exercise contraindications (i.e., if they select "no" to any question in the Get Active Questionnaire they must seek physician approval before exercising)
结局指标
主要结局
Feasibility - Recruitment
时间窗: 2 month (September to October 2019)
Definition: Number recruited at end of rollout. The criterion for success is to recruit 10 participants at each of 4 sites.
Feasibility - Retention
时间窗: Start of the program to 9 weeks
Definition: Number retrained at post-rollout end. The criterion for success is 90% at rollout end.
Feasibility - Adherence
时间窗: 16 sessions
Definition: Percentage of individuals that attended exercise and nutrition sessions. The criterion for success is 70% or higher.
次要结局
- Body Weight(Baseline)
- 10 Meter Walk Test(Mean change from follow up (study visit 4) and baseline)
- Grip Strength(Mean change from follow up (study visit 4) and baseline)
- 30 Second Chair Stand Test(Mean change from follow up (study visit 4) and baseline)
- 4 Square Step Test(Mean change from follow up (study visit 4) and baseline)
- EuroQol 5 Dimension Version 5-level (EQ-5D-5L)(Mean change from follow up (study visit 4) and baseline)
- Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool(Mean change from follow up (study visit 4) and baseline)
- Number of Participants With Adverse Events(Study visit 1, 2, 3 and 4)
- Participant and Provider Experience(study visit 4)