Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-02-23 @ 8:57 PM
Study NCT ID:
NCT01716832
Status:
COMPLETED
Last Update Posted:
2018-02-22
First Post:
2012-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Walking for Stress Reduction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-20', 'studyFirstSubmitDate': '2012-10-24', 'studyFirstSubmitQcDate': '2012-10-29', 'lastUpdatePostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cohens Perceived Stress Scale 14 Items', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Quality of Life (SF 36)', 'timeFrame': 'Baseline, 4 weeks, 12 weeks'}, {'measure': 'Subjective Stress Level (Visual Analogue Scale)', 'timeFrame': 'Baseline, 4 weeks, 12 weeks'}, {'measure': 'Assessment of effect on a Likert - Scale', 'timeFrame': '4 weeks, 12 weeks'}]}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'The effectiveness of a mindfulness walking program is tested in subjects with a high level of subjectively perceived stress.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men and women between 18 and 65 years\n* Increased level of stress (visual analog scale \\>40 mm (0-100))\n\nExclusion Criteria:\n\n* Regular walking training in the last 6 weeks\n* Medical therapy with psychopharmacological drugs\n* Regular mindfulness based meditations/exercises in the last 6 weeks\n* CAM therapies against stress in the last 6 weeks\n* medium or severe chronic diseases\n* Stress due to chronic diseases\n* Acute disease at inclusion\n* Not being able to walk'}, 'identificationModule': {'nctId': 'NCT01716832', 'briefTitle': 'Walking for Stress Reduction', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Effectiveness of Mindfulness Walking on Stress Reduction', 'orgStudyIdInfo': {'id': 'Walking_Stress_Reduction'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfulness walking', 'interventionNames': ['Behavioral: Mindfulness Walking']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention (waiting list)'}], 'interventions': [{'name': 'Mindfulness Walking', 'type': 'BEHAVIORAL', 'description': 'Mindful walking in a small group twice a week for 60 minutes within 4 weeks.', 'armGroupLabels': ['Mindfulness walking']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité University Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. MD', 'investigatorFullName': 'Benno Brinkhaus', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}