Increased Physical Activity Through Mindfulness

Physical Activity Clinical Trial

— FAR-MIND  

Official title:

Increased Adherence to Physical Activity on Prescription (PAP) Through Mindfulness- A Pilot Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02869854
• Other study ID #: Pny1
• Status: Completed
• Phase: N/A
• Start date: September 30, 2016
• Est. completion date: December 18, 2018

Study information

• Verified date: January 2019
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 18, 2018
• Est. primary completion date: December 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Life Style
• Mindfulness
• Physical Activity

Intervention

Behavioral:
• Mindfulness
Mindfulness course during 8 weeks with 20 minutes mindfulness exercise each day
• PAP
Physical Activity on Prescription, after 3 months a new prescription

Locations

Country	Name	City	State
Sweden	Lunds Unniversitet	Malmö	Skane

Sponsors (2)

Lead Sponsor	Collaborator
Region Skane	Lund University

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Nymberg P, Ekvall Hansson E, Stenman E, Calling S, Sundquist K, Sundquist J, Zöller 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of time, measured in minutes of activity during a week, between the three different groups measured by activity monitor Actigraph (GT3X)	Each individual will wear an activity monitor during 7 days. This will be done at baseline after 3 months and after 6 months	6 months
Secondary	Difference between the three groups in revised assessment of their self-rated health and	assessment based on terms of perceived health with five alternative answers very poor, poor, fair, good and very good	6 months
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 , feeling of being rested, how sleeping problems affecting daily life , and how sleep patterns concern the individual	6 months
Secondary	Differences between the three intervention groups regarding change in biomarkers such as proteins , micro - RNA , cytokines, mitochondrial DNA and telomeres	blood samples	6 months