A 12-week Intervention With Motivational Interviewing and Physical Activity Monitoring, to Enhance the Daily Amount of Physical Activity in Community Dwelling Older Adults - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Individual intervention period average of PAM measured steps per day
研究概览
简要总结
To investigate if motivational-interviewing will enhance the expected effect from physical activity monitors, on physical activity in older adults, we will conduct a two-arm randomized controlled trial in 2019.
Both groups in the trial will receive a physical activity monitor for everyday use in the 12-week intervention period and a folder with information about the benefits of physical activity in older age. Participants in the intervention group will in addition to the use of the physical activity monitors receive a motivational feedback session by phone of about 20 minutes constructed from the theoretical framework of Motivational interviewing by Rollnick, Miller & Butler and Social Cognitive Theory by Bandura. The content of the session focuses on investigating the most relevant possibilities and barriers for the participant to increase his or her levels of PA.
The primary outcome will be between group difference in average steps per day throughout the intervention period, measured objectively by the physical activity monitor (Garmin Vivofit 3). Secondary outcomes include participant reported outcome measures such as 'International Physical Activity Questionnaire', 'Nordic Physical Activity Questionnaire', 'EQ5D Quality of life questionnaire', 'UCLA Loneliness Scale', 'Self Efficacy for Exercise', and 'Outcome expectancy for Exercise'. To ensure 80% power with an alpha-level on 0.05, we will include 128 participants. The study will enroll in March 2019.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Primary investigator will be blinded for allocation before making the final analyses. No outcome assessments will be made by an assessor. Only objectively measured steps per day and participant reported outcome measures will be used for this study.
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must:
- •Be minimum 70 years of age at the time of inclusion
- •Own and use an Apple/Google/Microsoft smartphone device compatible with the Garmin Connect™ Mobile application.
- •Own use an e-mail account
- •Live in Denmark and have a Danish postal address and be able to receive the intervention content.
- •Be able to walk independently with or without assistive devices.
排除标准
- •Participants cannot
- •Receive active cancer treatment
- •Have major cognitive impairment (e.g. dementia or alzheimers).
- •Parkinson's or Multiple Sclerosis (or similar disease) affecting their mobility in such a way that the participants cannot walk on a daily basis.
结局指标
主要结局
Individual intervention period average of PAM measured steps per day
时间窗: A daily average of the 12 weeks of intervention
Daily step counts will be objectively measured by the PAM.
次要结局
- International Physical Activity Questionnaire(Baseline + end point at 12 weeks + follow up at 6 months and 12 months)
- Nordic Physical Activity Questionnaire(Baseline + end point at 12 weeks + follow up at 6 months and 12 months)
- EQ5D Quality of life questionnaire(Baseline + end point at 12 weeks + follow up at 6 months and 12 months)
- University of California, Los Angeles, Loneliness Scale(Baseline + end point at 12 weeks + follow up at 6 months and 12 months)
- Self Efficacy for Exercise(Baseline + end point at 12 weeks + follow up at 6 months and 12 months)
- Outcome expectancy for Exercise(Baseline + end point at 12 weeks + follow up at 6 months and 12 months)
研究者
Rasmus Tolstrup Larsen
Principal investigator
University of Copenhagen