Understanding Motivation Towards Exercise to Enhance Physical Activity on Prescription Adherence
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Self-reported exercise and physical activity
研究概览
简要总结
The goal of this clinical trial is to explore effectiveness on physical activity, function and psychometrics in relation to an exercise intervention in physically inactive middle-aged men and women. The main questions it aims to answer are:
- Is the exercise intervention effective in increasing physical activity, function and motivation towards exercise? Is there an intervention effect in physical activity, function and psychometrics at 6-, 12- and 24 months post baseline?
- Can barriers and facilitators towards increased physical activity be identified in the two groups of the study?
All participants will first receive standard care for physically inactive patients, i.e. Physical activity on Prescription (PaP), followed by allocation to an exercise intervention (EI) group or a control group. The EI group will be offered an additional exercise intervention for 16 weeks consisting of 1-2 training sessions per week of a combination of aerobic and resistance training at a private fitness centre. The control group will be asked to adhere to their PaP.
Researchers will assess physical activity, function and psychometrics in the two groups at 6-, 12- and 24 months to evaluate the intervention effect. Additionally, interviews with the participants in the control and EI groups will be performed in order to explore barriers and facilitators towards increased physical activity in formerly inactive patients.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physically inactive persons as defined as not meeting the current recommendations of at least 150 minutes of moderate to vigorous physical activity per week. This criterion is self-assessed by potential participants.
- •Age 40-60 years
排除标准
- •Physical disability that affects the ability to perform the exercise intervention.
- •Heart failure or severe degenerative disease, e.g. malignant cancer, multiple sclerosis etc.
- •Myocardial infarction or stroke during the last 12 months.
- •Heart conditions including angina pectoris that is worsened with exercise.
- •Neuromuscular, musculoskeletal, or rheumatic conditions that is worsened with exercise.
- •Hypertension grade III, i.e. systolic blood pressure above 180 mmHg and/or diastolic blood pressure over 110 mmHg.
研究组 & 干预措施
Exercise intervention
Participants are prescribed a Physical activity on Prescription (PaP) which means that they will have a motivational interview with a physiotherapist regarding increased physical activity. The physiotherapist will then prescribe a individualized PaP with the goal to increase weekly physical activity that the participant are instructed to adhere to for the remainder of the study. A follow-up session is also included after 16 weeks. Participants are invited to a 16 week exercise intervention at a private fitness center after they have received their PaP. The exercise, including a variety of aerobic and resistance training, is performed in a group setting starting with one session per week for the first two weeks and then two sessions per week for week 3-16. Follow-up tests is also included after 6-, 12- and 24 months.
干预措施: Supervised exercise in a group setting (Behavioral)
Exercise intervention
Participants are prescribed a Physical activity on Prescription (PaP) which means that they will have a motivational interview with a physiotherapist regarding increased physical activity. The physiotherapist will then prescribe a individualized PaP with the goal to increase weekly physical activity that the participant are instructed to adhere to for the remainder of the study. A follow-up session is also included after 16 weeks. Participants are invited to a 16 week exercise intervention at a private fitness center after they have received their PaP. The exercise, including a variety of aerobic and resistance training, is performed in a group setting starting with one session per week for the first two weeks and then two sessions per week for week 3-16. Follow-up tests is also included after 6-, 12- and 24 months.
干预措施: Usual care (Physical activity on Prescription) (Behavioral)
Control
Participants are prescribed a Physical activity on Prescription (PaP) which means that they will have a motivational interview with a physiotherapist regarding increased physical activity. The physiotherapist will then prescribe a individualized PaP with the goal to increase weekly physical activity that the participant are instructed to adhere to for the remainder of the study. A follow-up session is also included after 16 weeks. Follow-up tests is also included after 6-, 12- and 24 months.
干预措施: Usual care (Physical activity on Prescription) (Behavioral)
结局指标
主要结局
Self-reported exercise and physical activity
时间窗: Baseline, 6-, 12- and 24 months
One question regarding exercise and one question regarding every day physical activity in a typical week. The question regarding exercise comprises 6 answer alternatives ranging from 0 min to more than 120 min per week. The question regarding every day physical activity comprises 7 answer alternatives raging from 0 min to more than 300 min per week. The questions are produced by the Swedish National Board of Health and Welfare.
次要结局
- Device measured physical activity level(Baseline, 6-, 12- and 24 months)
- Daily step count(Baseline, 6-, 12- and 24 months)
- Cardio-respiratory capacity(Baseline, 6-, 12- and 24 months)
- Upper limb strength(Baseline, 6-, 12- and 24 months)
- Lower limb muscle strength(Baseline, 6-, 12- and 24 months)
- Motivational stages of self-determination for exercise(Baseline, 6-, 12- and 24 months)
- Confidence in one's own ability to exercise(Baseline, 6-, 12- and 24 months)
- Basic psychological needs connected to physical activity satisfaction(Baseline, 6-, 12- and 24 months)
- Health related quality of life(Baseline, 6-, 12- and 24 months)
研究者
Andreas Hult
Associate Professor
Umeå University