Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-02-28 @ 9:11 PM
Study NCT ID:
NCT02375594
Status:
UNKNOWN
Last Update Posted:
2015-03-02
First Post:
2015-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Park Equipment for Improving Physical Function and Physical Activity Levels in the Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057185', 'term': 'Sedentary Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-02-24', 'studyFirstSubmitDate': '2015-02-09', 'studyFirstSubmitQcDate': '2015-02-24', 'lastUpdatePostDateStruct': {'date': '2015-03-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical performance measured with the Short Physical Performance Battery', 'timeFrame': '6 months (3 months follow up after end of intervention)', 'description': 'Physical performance measured with the Short Physical Performance Battery'}, {'measure': 'Amount of moderate or intense physical activity assessed with the International Physical Activity Questionnaire', 'timeFrame': '6 months (3 months follow up after end of intervention)', 'description': 'Self reported weekly minutes of moderate or intense physical activity'}], 'secondaryOutcomes': [{'measure': 'Amount of physical activity in exercise park equipment assessed with the question "Estimate in minutes the duration of any moderate or intense physical activity that you conducted last week in the exercise park equipment"', 'timeFrame': '6 months (3 months follow up after end of intervention)', 'description': 'Self reported weekly minutes of moderate or intense physical activity conducted in the exercise park equipment'}, {'measure': 'Fatigability measured with the Pittsburgh Fatigability Scale for Older Adults', 'timeFrame': '6 months (3 months follow up after end of intervention)', 'description': 'Fatigability measured with the Pittsburgh Fatigability Scale for Older Adults'}, {'measure': 'Fatigability measured with the Pittsburgh Fatigability Scale for Older Adults', 'timeFrame': '3 months (e.g. at end of intervention)', 'description': 'Fatigability measured with the Pittsburgh Fatigability Scale for Older Adults'}, {'measure': 'Functionality measured with the Late Life Function and Disability test', 'timeFrame': '6 months (3 months follow up after end of intervention)', 'description': 'Functionality measured with the Late Life Function and Disability test'}, {'measure': 'Functionality measured with the Late Life Function and Disability test', 'timeFrame': '3 months (e.g. at end of intervention)', 'description': 'Functionality measured with the Late Life Function and Disability test'}, {'measure': 'Social participation measured with the Index of Subjective Social Participation', 'timeFrame': '6 months (3 months follow up after end of intervention)', 'description': 'Social participation measured with the Index of Subjective Social Participation'}, {'measure': 'Quality of life measured with SF-12', 'timeFrame': '6 months (3 months follow up after end of intervention)', 'description': 'Quality of life measured with SF-12'}, {'measure': 'Amount of moderate or intense physical activity assessed with the International Physical Activity Questionnaire', 'timeFrame': '3 months (e.g. at end of intervention)', 'description': 'Weekly minutes of moderate or intense physical activity'}, {'measure': 'Physical performance measured with the Short Physical Performance Battery', 'timeFrame': '3 months (e.g. at end of intervention)', 'description': 'Physical performance measured with the Short Physical Performance Battery'}, {'measure': 'Satisfaction assessed through open-ended questions', 'timeFrame': '3 months (e.g. at end of intervention)', 'description': 'Subjective satisfaction with the intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sedentary Lifestyle']}, 'descriptionModule': {'briefSummary': 'Exercise park equipments for the elderly are designed taking into account the physical and cognitive capabilities and needs of elderly individuals. These equipments are usually built in public spaces, and may be part of public health initiatives to promote active lifestyles in the elderly.\n\nPrevious research has provided clear evidence on the short-term efficacy of exercise programs in improving physical function and level of physical activity in community-dwelling elderly. The goal of this randomized clinical trial is to assess whether an exercise intervention conducted in an exercise park equipment is able to achieve sustained improvements in physical function and level of physical activity, that are maintained for at least 3 months after the end of the intervention. The target population are community-dwelling elderly that are insufficiently active.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals aged 70 years or more\n* Insufficiently active, defined as a person who does not meet the physical activity recommendations of World Health Organization (30 minutes per day of moderate physical activity (including active leisure and travel), 5 days a week; or 30 minutes per day of vigorous physical activity, 3 days a week).\n\nExclusion Criteria:\n\n* The individual refers not being able to walk 400 meters in 15 minutes or less without having to sit, lean, use a walker or require the assistance of another person.\n* Moderate or severe cognitive impairment (MiniMental \\<19).\n* Serious disease that limits physical activity (heart disease, cancer, chronic respiratory disease, joint replacements in the last 12 months, severe limitations of range of motion).\n* Serious mental illness that prevents participation.\n* Prescription of neuroleptic medication.'}, 'identificationModule': {'nctId': 'NCT02375594', 'briefTitle': 'Exercise Park Equipment for Improving Physical Function and Physical Activity Levels in the Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Fundacio Salut i Envelliment UAB'}, 'officialTitle': 'Sustained Effect of a 12 Week Guided Exercise Program Conducted in an Exercise Park Equipment in the Physical Function and Physical Activity Levels of Physically Inactive Elderly: Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'FSIE-LAPP-2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise in park equipment', 'description': 'Participants in the intervention arm will attend a 3-month long program of 2 weekly one-hour exercise sessions in the exercise park equipment, guided by a physical therapist. The sessions will comprise a combination of aerobic, strength, balance and flexibility exercises. Up to 20 participants exercising simultaneously in the equipment under the guidance of an experienced LAPPSET physical therapist.', 'interventionNames': ['Other: Exercise in park equipment']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants in the control arm will receive usual advice on healthy habits. During the study, they will be offered to attend the talks on healthy living for elderly periodically organised by their primary care centre (CAP Vallcarca - Sant Gervasi). At the end of the study, they will be invited to an exercise session at the exercise park equipment, conducted by the study physical therapist.'}], 'interventions': [{'name': 'Exercise in park equipment', 'type': 'OTHER', 'armGroupLabels': ['Exercise in park equipment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Esperança Palacios', 'role': 'CONTACT', 'phone': '932594411'}], 'facility': 'CAP Vallcarca-Sant Gervasi', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Eva Julià', 'role': 'CONTACT', 'phone': '934335014'}], 'facility': 'Fundació Salut i Envelliment', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Eva Julià', 'role': 'CONTACT', 'email': 'fsie@uab.cat', 'phone': '+34 934 335 030'}], 'overallOfficials': [{'name': 'Antoni Salvà, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fundació Salut i Envelliment'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacio Salut i Envelliment UAB', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lappset Group Oy, España', 'class': 'UNKNOWN'}, {'name': 'Institut Investigacio Sanitaria Pere Virgili', 'class': 'OTHER'}, {'name': 'Atenció Primària Vallcarca - Sant Gervasi', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}