Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-01-29 @ 12:23 AM
Study NCT ID:
NCT06509620
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-19
First Post:
2024-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical and Cognitive Performance in Older Adults With Fatigue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073216', 'term': 'Mental Status and Dementia Tests'}], 'ancestors': [{'id': 'D009483', 'term': 'Neuropsychological Tests'}, {'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-17', 'studyFirstSubmitDate': '2024-07-10', 'studyFirstSubmitQcDate': '2024-07-17', 'lastUpdatePostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome measure the difference in cognitive performance between older adults with and without fatigue, assessed using the Montreal Cognitive Assessment (MoCA)', 'timeFrame': '6 months', 'description': 'compare the MoCA scores between the fatigued and non-fatigued groups using appropriate statistical methods (e.g., t-tests or ANCOVA adjusting for potential confounders). MOCA score is 30 with 18-25 = mild cognitive impairment, - 10-17= moderate cognitive impairment and - less than 10= severe cognitive impairment.'}, {'measure': 'The primary outcome measure the difference in physical performance between older individuals with and without fatigue, assessed using 6 minutes walk test', 'timeFrame': '6 months', 'description': 'The primary outcome will compare the 6 minutes walk test between the fatigued and non-fatigued groups using appropriate statistical methods (e.g., t-tests or ANCOVA adjusting for potential confounders).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fatigue', 'older adult'], 'conditions': ['Fatigue']}, 'descriptionModule': {'briefSummary': 'Fatigue is a common symptom in older adults, often linked to various medical conditions, medications, and psychosocial factors, and it can adversely affect both physical and cognitive performance in the aging population, contributing to functional decline and reduced quality of life.\n\nAssessment of the physical impact of fatigue on physical and cognitive performance in older adults can offer valuable insights for clinical practice and holistic geriatric care. Therefore, this study will validate subjective tools used for measuring the impact of fatigue against objective measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Community dwelling elderly participants (caregivers of inpatients, attendants of primary care , elderly clubs and other community gatherings).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants aged 60 years old and above both males and females\n\nExclusion Criteria:\n\n* o Patients with acute medical illness.\n\n * Patients with life threatening illnesses.\n * Bedridden patients.\n * Patients with diagnosed malignancy.\n * Patients with debilitating chronic disease (end organ failure) (e.g. heart failure , renal failure, and liver cell failure).\n * Patients with neurological diseases (e.g. moderate to severe dementia, stroke, parkinsonism) that interfere with the assessment process.\n * Patients with musculoskeletal conditions that interfere with the assessment process (fracture, disabling osteoarthritis, painful arthritis).\n * Patients with severe uncorrected hearing loss, vision impairment, or aphasia that may impede effective communication during the assessment.'}, 'identificationModule': {'nctId': 'NCT06509620', 'briefTitle': 'Physical and Cognitive Performance in Older Adults With Fatigue', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Physical and Cognitive Performance in Older Adults With Fatigue', 'orgStudyIdInfo': {'id': 'MS313/2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cases', 'description': 'community dwelling elderly patients with fatigue. 70 Participants aged 60 years old and above both males and females with fatigue for at least 4 weeks not due to acute condition', 'interventionNames': ['Other: Fatigue severity scale']}, {'label': 'control', 'description': 'age and gender matched elderly patients without fatigue', 'interventionNames': ['Other: Fatigue severity scale']}], 'interventions': [{'name': 'Fatigue severity scale', 'type': 'OTHER', 'otherNames': ['Modified Fatigue Impact Scale', 'MONTREAL COGNITIVE ASSESSMENT', '6 Minute walk test'], 'description': 'fatigue severity scale is a unidimensional, nine-item questionnaire capturing information on the impact and severity of fatigue. Participants rated the 9-items on a 7-point, Likert-type scale with anchors of strongly disagree (1) and strongly agree (7) based on the previous week. The overall score is an average of the individual item scores and can range between 1 and 7.', 'armGroupLabels': ['cases', 'control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11566', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Doha Rasheedy, MD', 'role': 'CONTACT', 'email': 'doharasheedy@med.asu.edu.eg', 'phone': '01001193544'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Geriatrics and Gerontology', 'investigatorFullName': 'Doha Rasheedy', 'investigatorAffiliation': 'Ain Shams University'}}}}