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Completed

NCT Number: NCT02869854

Increased Physical Activity Through Mindfulness

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.

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Key information

Conditions

Physical Activity Behavior Life Style Mindfulness Motor Activity

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lunds Unniversitet

Malmö, Skåne County, 205 02, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness

Behavioral

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

PAP

Behavioral

Physical Activity on Prescription, after 3 months a new prescription

Primary outcomes

  1. 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

  1. Difference Between the Three Groups in Revised Assessment of Their Self-rated Health

    Time frame: base-line ,3 months, 6 months

    assessment based on terms of perceived health with five alternative answers, a higher score incdicates a better outcome

    • very poor
    • poor
    • fair
    • good
    • very good

  2. Difference Between Groups in the Amount of Self-perceived Sleep Problems

    Time frame: Baseline, 3 months, 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, 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

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Lund University

Registry information

Official study title

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

Acronym: FAR-MIND

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 17, 2016
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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