Clinical trial NCT02869854: Increased Physical Activity Through Mindfulness
Official title: Increased Adherence to Physical Activity on Prescription (PAP) Through Mindfulness- A Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Life Style
Mindfulness
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2016-08-17
Enrollment: 88
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: 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)
timeFrame: Baseline ,6 months.
Secondary outcomes:
measure: Difference Between the Three Groups in Revised Assessment of Their Self-rated Health
timeFrame: base-line ,3 months, 6 months
measure: Difference Between Groups in the Amount of Self-perceived Sleep Problems
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Lunds Unniversitet
state: Skane
Study officials:
affiliation: Lunds University
name: Bengt Zöller, Docent
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.