Physical Activity on Prescription With Two Different Strategies. One Year Follow-up Regarding Physical Activity Level, Metabolic Health and Health-related Quality of Life. A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Change in self-assessed PA-level - a six grade PA scale
研究概览
简要总结
The aim of this study is to evaluate a one year intervention with physical activity on prescription (PAP) treatment for patients in a primary health care center setting versus an enhanced PAP-support with physiotherapist regarding physical activity (PA) level, metabolic health effects and health-related quality of life.
One hundred ninety patients, 27-85 years, physically inactive, having at least one component of the metabolic syndrome and not responding with increased PA level after a 6-months PAP-treatment in primary health care centre are randomized to either enhanced support by physiotherapist (Intervention group) or continued ordinary PAP-treatment at the health care centre (Control group).
详细描述
Aim:
The aim is to evaluate whether an enhanced support with physiotherapist for patients who are non-responders to PAP-treatment at 6 months follow-up in a primary health care centre setting influences physical activity level, metabolic health effects and health-related quality of life.
Methods:
Study design:
This is a randomized controlled trial (RCT) with two arms: one intervention group and one control group. The present study is part of an ongoing study including 444 patients with a 5 years follow-up.
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
- None
入排标准
- 年龄范围
- 27 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physically inactive according to ACSM/AHA public health recommendation from
- •Having at least one component of the metS present according to the NCEP classification.
- •Receiving PAP-treatment.
- •Understanding the Swedish language.
排除标准
- •The patient decline to participate.
结局指标
主要结局
Change in self-assessed PA-level - a six grade PA scale
时间窗: Change between baseline and one year follow-up.
A six-grade PA scale is a further development of the SGPALS (Frändin/Grimby), and includes household activities. This scale correlates with physical performance and self-assessed fitness and is used to classify PA among elderly
Change in self-assessed PA-level - IPAQ
时间窗: Change between baseline and one year follow-up.
The International physical activity questionnaire (IPAQ) assessing the level of PA during the last seven days. The instrument is extensively tested and translated into Swedish and vigorous-, moderate-intensity PA, walking and sitting time can be assessed.
Change in self-assessed PA-level - SGPALS
时间窗: Change between baseline and one year follow-up.
The Saltin-Grimby physical activity level scale (SGPALS) assessing leisure time PA during the past year in four different levels, from sedentary/physically inactive to vigorous physically active. The levels has been validated against e.g. metabolic risk factors and has been published in an updated Swedish form.
Change in self-assessed PA-level according to the public health recommendation.
时间窗: Change between baseline and one year follow-up.
Self-assessment of PA-level according to American college of sports medicine (ACSM) and American heart association (AHA) public health recommendation 2007. The patient responds to two PA questions, where 30 minutes of moderate-intensity PA per day results in 1 point and 20 minutes of more vigorous-intensity PA per day results in 1.7 point during each specific day of the week. A value of \<5 points indicates an inadequate PA level.
次要结局
- Change in blood samples - Low Density Lipoprotein (LDL).(Change between baseline and one year follow-up.)
- Change in anthropometrics - Waist circumference (WC)(Change between baseline and one year follow-up.)
- Change in diastolic blood pressure (DBP)(Change between baseline and one year follow-up.)
- Change in blood samples - Triglycerides (TG).(Change between baseline and one year follow-up.)
- Change in anthropometrics - Body mass index (BMI)(Change between baseline and one year follow-up.)
- Change in health related quality of life - Short Form 36 (SF-36)(Change between baseline and one year follow-up.)
- Change in systolic blood pressure (SBP)(Change between baseline and one year follow-up.)
- Change in blood samples - Plasma glucose after an overnight fast (FPG).(Change between baseline and one year follow-up.)
- Change in blood samples - Cholesterol.(Change between baseline and one year follow-up.)
- Change in blood samples - High Density Lipoprotein (HDL).(Change between baseline and one year follow-up.)