Physical ActivityFAR-MINDNCT02869854
Increased Physical Activity Through Mindfulness
A study testing Mindfulness and PAP in people with Physical Activity and Life Style, run by Region Skane at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Life Style, Mindfulness
- What is being tested?
- Mindfulness and PAP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSweden
- Study dates
- 30 Sep 2016to 18 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increased Adherence to Physical Activity on Prescription (PAP) Through Mindfulness- A Pilot Study.
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.
Read the 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.
- Conditions
- Physical Activity, Life Style, Mindfulness
- Being tested
- Mindfulness, PAP
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessBehavioural
Mindfulness course during 8 weeks with 20 minutes mindfulness exercise each day
PAPBehavioural
Physical Activity on Prescription, after 3 months a new prescription
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: PAP |
| 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. Receives: Behavioral: Mindfulness |
| 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 Receives: Behavioral: Mindfulness; Behavioral: PAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline ,6 months.
Secondary outcomes (2)
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
- very poor
- poor
- fair
- good
- very good
Measured: base-line ,3 months, 6 months
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
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study start30 Sep 2016
- Primary completion18 Dec 2018
- Study completion18 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Sponsor
- Investigators
- Bengt Zöller, Docent, Principal investigator, Lunds University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869854
- Sponsor's protocol ID
- Pny1
- Acronym
- FAR-MIND
- Status last verified
- Feb 2024
- First submitted
- 8 Aug 2016
- Last updated
- 16 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 30333052Nymberg 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.
PubMed 33731219
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increased Adherence to Physical Activity on Prescription (PAP) Through Mindfulness- A Pilot Study.
- ClinicalTrials.gov ID
- NCT02869854
- Acronym / sponsor ID
- FAR-MIND / Pny1
- Conditions
- Physical Activity, Life Style, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- 30 Sep 2016 (actual)
- Primary completion
- 18 Dec 2018 (actual)
- Study completion
- 18 Dec 2018 (actual)
- First posted
- 17 Aug 2016 (estimated)
- Results
- Posted 16 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PAP only | Active comparator | Behavioral: PAPThis 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. |
| Mindfulness only | Active comparator | Behavioral: MindfulnessMindfulness. 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. |
| Combination of the two groups | Experimental | Behavioral: Mindfulness, Behavioral: PAPMindfulness 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 |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MindfulnessMindfulness course during 8 weeks with 20 minutes mindfulness exercise each day | Behavioural | Combination of the two groups, Mindfulness only |
| PAPPhysical Activity on Prescription, after 3 months a new prescription | Behavioural | Combination of the two groups, PAP only |
Primary outcome
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
2 secondary outcomes
Difference Between the Three Groups in Revised Assessment of Their Self-rated Health
Time frame: base-line ,3 months, 6 months
Difference Between Groups in the Amount of Self-perceived Sleep Problems
Time frame: Baseline, 3 months, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30333052Nymberg 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.
- Derived from this study: PubMed 33731219Nymberg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bengt Zöller, Docent principal investigator
Lunds University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness and PAP in people with Physical Activity and Life Style, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: Baseline ,6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02869854, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025; AzTrials last refreshed its copy on 28 Oct 2026.