Increased Physical Activity Through Mindfulness

NCT02869854 | Completed Results

• 1 other identifier: Pny1
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Activity; Life Style; Mindfulness

Outcome Measures

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)

  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 ,6 months.

Secondary Outcomes (2)

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

  base-line ,3 months, 6 months

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

  Baseline, 3 months, 6 months

Study Arms (3)

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.

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.

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

Behavioral: Mindfulness; Behavioral: PAP

Interventions

Mindfulness BEHAVIORAL

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

Combination of the two groups; Mindfulness only

PAP BEHAVIORAL

Physical Activity on Prescription, after 3 months a new prescription

Combination of the two groups; PAP only

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Skane: lead
• Lund University: collaborator

Study Sites (1)

Lunds Unniversitet

Malmo, Skåne County, 205 02, Sweden

Location

Related Publications (2)

• 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.

  PMID: 30333052 BACKGROUND

• 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.

  PMID: 33731219 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Mr Peter Nymberg
• Organization: RegionSkane

peter.nymberg@med.lu.se

0705759810

Study Officials

• Bengt Zöller, Docent

  Lunds University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 17, 2016
• Study Start: September 30, 2016
• Primary Completion: December 18, 2018
• Study Completion: December 18, 2018
• Last Updated: April 16, 2025
• Results First Posted: April 16, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)