Exploring the Addition of Strength and Balance Exercise Into Traditional Community-based Maintenance Cardiac Rehabilitation Classes in Older Adults: A Pilot Cluster Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- 30-Second Chair Stand
研究概览
简要总结
The goal of this cluster randomised clinical trial is to investigate the impact of adding strength and balance exercises into traditional aerobic-based Cardiac Rehabilitation Community/Maintenance classes on the functional fitness of older adults.
The main questions it aims to answer are:
- To explore participants' functional fitness changes,
- Confidence in balance,
- Concerns about falling compared to those participating in traditional aerobic-based cardiac rehabilitation only.
- Understand the perceptions of participants regarding the addition of strength and balance into classes.
- Understand the views of exercise professionals delivering the classes with additional strength and balance.
Participants:
- Will get their Functional fitness measured using the Functional Fitness MOT at baseline, and carry out questionnaires on their current physical activity levels, confidence in balance and concerns about falling.
- The traditional aerobic-based cardiac rehabilitation classes (Clusters) will be randomised into Intervention Groups (additional strength and balance added) and usual care (Control Groups).
- After 12 weeks, Functional Fitness and the questionnaires will be reassessed.
- Two weeks after the 12-week follow-up, participants will be invited to an online focus group on Microsoft Teams to understand their perceptions of strength and balance.
- Additionally, exercise Leaders will be invited to an interview on Microsoft Teams to discuss their views on strength and balance incorporation into maintenance cardiac rehabilitation classes.
详细描述
Study Design: This will be a pilot cluster RCT. The control group participants will remain in traditional aerobics-based cardiac rehabilitation. The intervention group participants will undergo additional strength and balance exercises within their cardiac rehabilitation classes).
Location: All classes will occur in their current venues (community). Baseline and follow-up functional fitness tests and questionnaires will take place in these same venues. Focus-groups (participants in the Intervention Group) and interviews (exercise leaders) will take place online using Microsoft Teams.
Length of time participants will be involved in the study:
Participants in Cardiac Rehabilitation Groups - 30/40-minute appointment (at their normal venue for their classes) in February/March 2026 for Functional Fitness testing, 12-week follow up testing and 60-90-minute focus group online appointment in June 2026. Exercise Leaders (Intervention Group) will be interviewed at the end of the study (maximum 60 minutes).
Participants: The study population will be older adults aged 50+ in Scotland attending Community/Maintenance Cardiac Rehabilitation classes.
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
- None
盲法说明
Randomisation was performed by a person independent from the study team
入排标准
- 年龄范围
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English-speaking older adults
- •Aged ≥50 years old
- •Able to provide written informed consent
- •Currently engaged with community-based Maintenance Cardiac Rehabilitation exercise classes within Scotland for at least 6 months
排除标准
- •Show symptoms of an unstable cardiovascular medical condition
- •Have moderate or severe cognitive impairment (can neither understand nor write the informed consent form, and/or cannot follow instructions)
- •Have upper or lower limb amputation
- •Have had upper or lower limb fractures in the past six months.
研究组 & 干预措施
Additional Strength and Balance Exercises
Addition of strength and balance to traditional aerobic-based cardiac rehabilitation
干预措施: Strength and balance added to traditional aerobic-based cardiac rehabilitation (Behavioral)
Usual Care
Traditional aerobic-based cardiac rehabilitation
干预措施: Control Group (Behavioral)
结局指标
主要结局
30-Second Chair Stand
时间窗: Baseline and 12 weeks
Single Leg Stance Test
时间窗: Baseline and 12 weeks
次要结局
- Hand-held Dynamometer / Grip Strength(Baseline and 12 weeks)
- 8-Foot Timed Up and Go(Baseline and 12 weeks)
- Chair Sit and Reach(Baseline and 12 weeks)
- Apley's Back Scratch Test(Baseline and 12 weeks)
- Rapid Assessment of Physical Activity(Baseline and 12 weeks)
- Confidence in Balance(Baseline and 12 weeks)
- Falls Efficacy Scale - International(Baseline and 12 weeks)