Walking for Stress Reduction | NCT01716832

Studies
Walking for Stress Reduction

NCT01716832

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Feb 22, 2018Actual

Enrollment

74Actual

Phase

Not Applicable

Conditions

Healthy Subjects

Interventions

Mindfulness Walking

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Sep 2011Actual

Completion Date

Nov 2011Actual

First Submitted Date

Oct 24, 2012

First Submission Date that Met QC Criteria

Oct 29, 2012

First Posted Date

Oct 30, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2018

Last Update Posted Date

Feb 22, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Benno Brinkhaus, Prof. MD, Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Not provided

Description Module

Brief Summary

The effectiveness of a mindfulness walking program is tested in subjects with a high level of subjectively perceived stress.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

74Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mindfulness walking	Experimental		Behavioral: Mindfulness Walking
No intervention (waiting list)	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mindfulness Walking	Behavioral	Mindful walking in a small group twice a week for 60 minutes within 4 weeks.	Mindfulness walking

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cohens Perceived Stress Scale 14 Items		4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Quality of Life (SF 36)		Baseline, 4 weeks, 12 weeks
Subjective Stress Level (Visual Analogue Scale)		Baseline, 4 weeks, 12 weeks
Assessment of effect on a Likert - Scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy men and women between 18 and 65 years
Increased level of stress (visual analog scale >40 mm (0-100))

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charité University Berlin		Berlin		10117	Germany