Increased Adherence to Physical Activity on Prescription (PAP) Through Mindfulness- A Pilot Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Region Skane
- Enrollment
- 88
- Locations
- 2
- Primary Endpoint
- Difference in Percentage of Time Spent Per Physical Activity Level Per Week of Time, Between the Three Different Groups Measured by Activity Monitor Actigraph (GT3X)
Study Overview
Brief Summary
In a pilot study, 90 physically inactive patients will be opportunistically and consecutively recruited and randomized to three intervention groups: mindfulness training, Physical Activity on Prescription (PAP) or only PAP. Follow-up will be done at baseline, three and six months with questionnaires, accelerometers and analysis of traditional risk factors to evaluate whether mindfulness may increase physical activity and decrease physical inactivity.
Detailed Description
All patients between 40 and 65 years of age who fulfil the inclusion criteria will be asked to participate in the study. Posters with information about the study will be put in the waiting room and in other strategic places. Patients who accept to participate will get written and oral information; they will sign an informed consent after the information. The patients will estimate their level of physical activity in minutes per week to control inclusion criteria. The patients will return in the morning for fasting blood samples and get an accelerometer attached to them to wear for 7 days. During this time, randomization will be performed. They will also get to answer a couple of different surveys. The results from the surveys and blood samples will be the study baseline.
All patients with abnormal test results will follow a specific flow diagram for the usual care.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Individuals between 40-65 years of age, with insufficient physical activity ( <150 minutes of moderate-intensity physical activity throughout the week, or < 75 minutes of vigorous-intensity physical activity throughout the week, or an equivalent combination of moderate- and vigorous-intensity activity.)
Exclusion Criteria
- •Dementia, severe mental disorder,newly diagnosed untreated unstable angina pectoris,myocardial infarction within 6 weeks prior to study entry. Individuals who do not master the Swedish language in speech and writing will be excluded.The patients who have abnormal values according to guidelines that require contact with a physician on the same day or week will also be excluded
Arms & Interventions
PAP only
This group will follow the referral scheme for three months, and after this period they will leave new blood samples and answer surveys. They will get a new PAP with follow up after another 3 months.
Intervention: PAP (Behavioral)
Mindfulness only
Mindfulness. This group will receive a group course in mindfulness during 8 weeks once a week, and with 20 minutes of daily personal training. Three and six months after inclusion they will answer a new set of surveys and fasting blood samples.
Intervention: Mindfulness (Behavioral)
Combination of the two groups
Mindfulness and physical activity prescription. This group will get a combination of the two other groups. PAP will be prescribed during the first meeting and another one after 3 months. During the first 8 weeks once a week they will participate in a mindfulness training group and also preform 20 minutes of daily training. The same surveys as the other groups and fasting blood samples
Intervention: Mindfulness (Behavioral)
Combination of the two groups
Mindfulness and physical activity prescription. This group will get a combination of the two other groups. PAP will be prescribed during the first meeting and another one after 3 months. During the first 8 weeks once a week they will participate in a mindfulness training group and also preform 20 minutes of daily training. The same surveys as the other groups and fasting blood samples
Intervention: PAP (Behavioral)
Outcomes
Primary Outcomes
Difference in Percentage of Time Spent Per Physical Activity Level Per Week of Time, Between the Three Different Groups Measured by Activity Monitor Actigraph (GT3X)
Time Frame: Baseline ,6 months.
Each individual will wear an activity monitor for 7 days. This will be done at baseline and after 6 months. The difference in the time of physical activity level was measured in minutes of activity during a week and then divided into percentages of sedentary time, light physical activity time and moderate to vigourous physical activity time, measured by activity monitor Actigraph (GT3X). In the analysis
Secondary Outcomes
- Difference Between the Three Groups in Revised Assessment of Their Self-rated Health(base-line ,3 months, 6 months)
- Difference Between Groups in the Amount of Self-perceived Sleep Problems(Baseline, 3 months, 6 months)