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Increased Physical Activity Through Mindfulness (FAR-MIND)

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ClinicalTrials.gov Identifier: NCT02869854
Recruitment Status : Completed
First Posted : August 17, 2016
Last Update Posted : February 1, 2019
Sponsor:
Collaborator:
Lund University
Information provided by (Responsible Party):
Region Skane

Brief Summary:
In a pilot study 90 physically inactive patients will be randomized to three different intervention groups; mindfulness training, mindfulness training and 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.

Condition or disease Intervention/treatment Phase
Physical Activity Life Style Mindfulness Behavioral: Mindfulness Behavioral: PAP Not Applicable

Detailed Description:

All patients between 40 and 65 years of age who fulfills 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 on other strategic places. Patients who accept to participate will get both written and orally information, after the information they will sign a informed consent. The patients will estimate their level of physical activity in minutes per week to control inclusion criteria. The patients will return a morning for fasting blood samples and get an accelerometer attached to them to wear during 7 days. During this time randomization will be preformed. 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 specific flow diagram for the usual care.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Increased Adherence to Physical Activity on Prescription (PAP) Through Mindfulness- A Pilot Study.
Actual Study Start Date : September 30, 2016
Actual Primary Completion Date : December 18, 2018
Actual Study Completion Date : December 18, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Behavioral: PAP
Physical Activity on Prescription, after 3 months a new prescription

Active Comparator: 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.
Behavioral: Mindfulness
Mindfulness course during 8 weeks with 20 minutes mindfulness exercise each day

Experimental: 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
Behavioral: Mindfulness
Mindfulness course during 8 weeks with 20 minutes mindfulness exercise each day

Behavioral: PAP
Physical Activity on Prescription, after 3 months a new prescription




Primary Outcome Measures :
  1. Difference of time, measured in minutes of activity during a week, between the three different groups measured by activity monitor Actigraph (GT3X) [ Time Frame: 6 months ]
    Each individual will wear an activity monitor during 7 days. This will be done at baseline after 3 months and after 6 months


Secondary Outcome Measures :
  1. Difference between the three groups in revised assessment of their self-rated health and [ Time Frame: 6 months ]
    assessment based on terms of perceived health with five alternative answers very poor, poor, fair, good and very good

  2. Difference between groups in the amount of self-perceived sleep problems [ Time Frame: 6 months ]
    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 , feeling of being rested, how sleeping problems affecting daily life , and how sleep patterns concern the individual

  3. Differences between the three intervention groups regarding change in biomarkers such as proteins , micro - RNA , cytokines, mitochondrial DNA and telomeres [ Time Frame: 6 months ]
    blood samples



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02869854


Locations
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Sweden
Lunds Unniversitet
Malmö, Skane, Sweden, 205 02
Sponsors and Collaborators
Region Skane
Lund University
Investigators
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Principal Investigator: Bengt Zöller, Docent Lunds University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT02869854    
Other Study ID Numbers: Pny1
First Posted: August 17, 2016    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided