Healthy SubjectsNCT01716832
Walking for Stress Reduction
A study testing Mindfulness Walking in people with Healthy Subjects, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The effectiveness of a mindfulness walking program is tested in subjects with a high level of subjectively perceived stress. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Mindfulness Walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2011to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men and women between 18 and 65 years
- Increased level of stress (visual analog scale >40 mm (0-100))
Who cannot join
- Regular walking training in the last 6 weeks
- Medical therapy with psychopharmacological drugs
- Regular mindfulness based meditations/exercises in the last 6 weeks
- CAM therapies against stress in the last 6 weeks
- medium or severe chronic diseases
- Stress due to chronic diseases
- Acute disease at inclusion
- Not being able to walk
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Mindfulness Walking on Stress Reduction
The effectiveness of a mindfulness walking program is tested in subjects with a high level of subjectively perceived stress.
- Conditions
- Healthy Subjects
- Being tested
- Mindfulness Walking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness WalkingBehavioural
Mindful walking in a small group twice a week for 60 minutes within 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness walking | Experimental | Not described Receives: Behavioral: Mindfulness Walking |
| No intervention (waiting list) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohens Perceived Stress Scale 14 Items
Measured: 4 weeks
Secondary outcomes (3)
Quality of Life (SF 36)
Measured: Baseline, 4 weeks, 12 weeks
Subjective Stress Level (Visual Analogue Scale)
Measured: Baseline, 4 weeks, 12 weeks
Assessment of effect on a Likert - Scale
Measured: 4 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startMar 2011
- Primary completionSep 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benno Brinkhaus, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716832
- Sponsor's protocol ID
- Walking_Stress_Reduction
- Status last verified
- Feb 2018
- First submitted
- 24 Oct 2012
- Last updated
- 22 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mindfulness Walking on Stress Reduction
- ClinicalTrials.gov ID
- NCT01716832
- Acronym / sponsor ID
- Walking_Stress_Reduction
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 30 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effectiveness of a mindfulness walking program is tested in subjects with a high level of subjectively perceived stress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness walking | Experimental | Behavioral: Mindfulness Walking |
| No intervention (waiting list) | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy men and women between 18 and 65 years
- Increased level of stress (visual analog scale >40 mm (0-100))
Key exclusion criteria (8 listed)
- Regular walking training in the last 6 weeks
- Medical therapy with psychopharmacological drugs
- Regular mindfulness based meditations/exercises in the last 6 weeks
- CAM therapies against stress in the last 6 weeks
- medium or severe chronic diseases
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 |
|---|---|---|
| Mindfulness WalkingMindful walking in a small group twice a week for 60 minutes within 4 weeks. | Behavioural | Mindfulness walking |
Primary outcome
Cohens Perceived Stress Scale 14 Items
Time frame: 4 weeks
3 secondary outcomes
Quality of Life (SF 36)
Time frame: Baseline, 4 weeks, 12 weeks
Subjective Stress Level (Visual Analogue Scale)
Time frame: Baseline, 4 weeks, 12 weeks
Assessment of effect on a Likert - Scale
Time frame: 4 weeks, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Walking in people with Healthy Subjects, run by Charite University, Berlin, Germany at 1 site in Germany.
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 2 inclusion and 8 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 22 Feb 2018. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cohens Perceived Stress Scale 14 Items (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Feb 2018.