NCT02869854: FAR-MIND

Increased Physical Activity Through Mindfulness

Completed NA Results posted Last updated 16 April 2025

What this trial tests

NA trial testing Mindfulness in Physical Activity in 88 participants. Completed in 18 December 2018.

Timeline

30 September 2016

Primary endpoint
18 December 2018

18 December 2018

Quick facts

Lead sponsor	Region Skane
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	88
Start date	30 September 2016
Primary completion	18 December 2018
Estimated completion	18 December 2018
Sites	1 location across Sweden

Drugs / interventions tested

• Mindfulness
• PAP

Conditions studied

• Physical Activity — all drugs for Physical Activity →
• Life Style — all drugs for Life Style →
• Mindfulness — all drugs for Mindfulness →

Sponsor

Region Skane — full company profile →

Who can join

Adults 40 to 65, any sex, with Physical Activity or Life Style. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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) Primary · 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

Baseline:Percent of time in sedentary time

Group	Value	95% CI
PAP Only	66.2	± 6.7
Mindfulness Only	65.5	± 9.2
Combination of the Two Groups	66.7	± 8.8

Baseline:Percent of time in LIPA

Group	Value	95% CI
PAP Only	30.9	± 6.2
Mindfulness Only	31.7	± 8.2
Combination of the Two Groups	30.3	± 8.0

Baseline:Percent of time in MVPA

Group	Value	95% CI
PAP Only	2.6	± 0.18
Mindfulness Only	2.3	± 0.02
Combination of the Two Groups	2.4	± 0.02

6 months:Percent of time in sedentary time

Group	Value	95% CI
PAP Only	65.0	± 6.8
Mindfulness Only	65.9	± 9.4
Combination of the Two Groups	64.0	± 9.1

6 months Percent of LIPA

Group	Value	95% CI
PAP Only	32.0	± 5.8
Mindfulness Only	31.6	± 9.0
Combination of the Two Groups	32.8	± 8.9

6 months: Percent of MVPA

Group	Value	95% CI
PAP Only	2.6	± 0.02
Mindfulness Only	1.9	± 0.02
Combination of the Two Groups	2.7	± 0.02

Difference Between the Three Groups in Revised Assessment of Their Self-rated Health Secondary · base-line ,3 months, 6 months

assessment based on terms of perceived health with five alternative answers, a higher score incdicates a better outcome 1. very poor 2. poor 3. fair 4. good 5. very good

Baseline

Group	Value	95% CI
PAP Only	3	1 – 4
Mindfulness Only	3	2 – 5
Combination of the Two Groups	3	2 – 5

3 months

Group	Value	95% CI
PAP Only	3	1 – 4
Mindfulness Only	3	2 – 5
Combination of the Two Groups	4	2 – 5

6 months

Group	Value	95% CI
PAP Only	4	1 – 4
Mindfulness Only	4	2 – 5
Combination of the Two Groups	4	2 – 5

Difference Between Groups in the Amount of Self-perceived Sleep Problems Secondary · 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

Insomnia Severity Index baseline

Group	Value	95% CI
PAP Only	8	0 – 24
Mindfulness Only	11	0 – 27
Combination of the Two Groups	10	0 – 21

Insomnia Severity Index 3 months

Group	Value	95% CI
PAP Only	7	0 – 20
Mindfulness Only	11	0 – 27
Combination of the Two Groups	9	0 – 27

Insomnia Severity Index 6 months

Group	Value	95% CI
PAP Only	6	0 – 18
Mindfulness Only	13	0 – 25
Combination of the Two Groups	9	0 – 18

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of mindfulness on physical activity in primary healthcare patients: a randomised controlled trial pilot study.
   Nymberg P, Calling S, Stenman E, Palmér K, et al · · 2021 · cited 3× · PMID 33731219 · DOI 10.1186/s40814-021-00810-6
2. Pilot study on increased adherence to physical activity on prescription (PAP) through mindfulness: study protocol.
   Nymberg P, Ekvall Hansson E, Stenman E, Calling S, et al · · 2018 · cited 2× · PMID 30333052 · DOI 10.1186/s13063-018-2932-9
3. Effect of mindfulness on physical activity in primary healthcare patients: a randomised controlled trial pilot study.
   Nymberg P, Calling S, Stenman E, Palmér K, et al · · 2020 · DOI 10.21203/rs.3.rs-23021/v2