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| Name | Class |
|---|---|
| Lund University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAP only | Active Comparator | 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. |
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| Mindfulness only | Active Comparator | 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. |
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| Combination of the two groups | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness | Behavioral | Mindfulness course during 8 weeks with 20 minutes mindfulness exercise each day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | Baseline ,6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference Between the Three Groups in Revised Assessment of Their Self-rated Health | assessment based on terms of perceived health with five alternative answers, a higher score incdicates a better outcome
| base-line ,3 months, 6 months |
| Difference Between Groups in the Amount of Self-perceived Sleep Problems |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bengt Zöller, Docent | Lunds University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lunds Unniversitet | Malmö | Skåne County | 205 02 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30333052 | Background | Nymberg P, Ekvall Hansson E, Stenman E, Calling S, Sundquist K, Sundquist J, Zoller B. Pilot study on increased adherence to physical activity on prescription (PAP) through mindfulness: study protocol. Trials. 2018 Oct 17;19(1):563. doi: 10.1186/s13063-018-2932-9. | |
| 33731219 | Derived | Nymberg P, Calling S, Stenman E, Palmer K, Hansson EE, Sundquist K, Sundquist J, Zoller B. Effect of mindfulness on physical activity in primary healthcare patients: a randomised controlled trial pilot study. Pilot Feasibility Stud. 2021 Mar 17;7(1):70. doi: 10.1186/s40814-021-00810-6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. PAP: Physical Activity on Prescription, after 3 months a new prescription |
| FG001 | 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. Mindfulness: Mindfulness course during 8 weeks with 20 minutes mindfulness exercise each day |
| FG002 | 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 Mindfulness: Mindfulness course during 8 weeks with 20 minutes mindfulness exercise each day PAP: Physical Activity on Prescription, after 3 months a new prescription |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. PAP: Physical Activity on Prescription, after 3 months a new prescription |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | 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 | Baseline and 6 months follow-up after inclusion. Change in percentage of sedentary time and time in different intensity of physical activity per valid day and averaged over the number of valid days, activity monitor measured | Posted | Mean | Standard Deviation | percentage of time | Baseline ,6 months. |
|
baseline, 3 months, 6 months
no adverse events appeared
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. PAP: Physical Activity on Prescription, after 3 months a new prescription |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mr Peter Nymberg | RegionSkane | 0705759810 | peter.nymberg@med.lu.se |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 28, 2016 | Mar 21, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 17, 2016 | Mar 21, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 28, 2016 | Mar 21, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| PAP | Behavioral | Physical Activity on Prescription, after 3 months a new prescription |
|
Insomnia Severity Index(ISI); is a self-report questionnaire measuring insomnia symptoms to evaluate the degree of insomnia. The scale consists of seven questions that evaluate Sleep mode, sleep during the night, waking up early, the feeling of being rested, how sleeping problems affect daily life, and how sleep patterns concern the individual. The higher the score, the better the outcome. Minimun score = 0, Maximum score = 28 |
| Baseline, 3 months, 6 months |
| 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. Mindfulness: Mindfulness course during 8 weeks with 20 minutes mindfulness exercise each day |
| BG002 | 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 Mindfulness: Mindfulness course during 8 weeks with 20 minutes mindfulness exercise each day PAP: Physical Activity on Prescription, after 3 months a new prescription |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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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.
PAP: Physical Activity on Prescription, after 3 months a new prescription
| OG001 | 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. Mindfulness: Mindfulness course during 8 weeks with 20 minutes mindfulness exercise each day |
| OG002 | 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 Mindfulness: Mindfulness course during 8 weeks with 20 minutes mindfulness exercise each day PAP: Physical Activity on Prescription, after 3 months a new prescription |
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| Secondary | Difference Between the Three Groups in Revised Assessment of Their Self-rated Health | assessment based on terms of perceived health with five alternative answers, a higher score incdicates a better outcome
| The number decreases during the study due to dropout, lost to follow-up. | Posted | Mean | Full Range | score on a scale | base-line ,3 months, 6 months |
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| Secondary | Difference Between Groups in the Amount of Self-perceived Sleep Problems | Insomnia Severity Index(ISI); is a self-report questionnaire measuring insomnia symptoms to evaluate the degree of insomnia. The scale consists of seven questions that evaluate Sleep mode, sleep during the night, waking up early, the feeling of being rested, how sleeping problems affect daily life, and how sleep patterns concern the individual. The higher the score, the better the outcome. Minimun score = 0, Maximum score = 28 | decreasing numbers due to drop-out | Posted | Median | Full Range | score on a scale | Baseline, 3 months, 6 months |
|
|
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| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | 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. Mindfulness: Mindfulness course during 8 weeks with 20 minutes mindfulness exercise each day | 0 | 29 | 0 | 29 | 0 | 29 |
| EG002 | 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 Mindfulness: Mindfulness course during 8 weeks with 20 minutes mindfulness exercise each day PAP: Physical Activity on Prescription, after 3 months a new prescription | 0 | 27 | 0 | 27 | 0 | 27 |
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| 3 months |
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| 6 months |
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| Insomnia Severity Index 3 months |
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| Insomnia Severity Index 6 months |
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