- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06509620
Physical and Cognitive Performance in Older Adults With Fatigue
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.
Assessment 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.
Study Overview
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Doha Rasheedy, MD
- Phone Number: 01001193544
- Email: doharasheedy@med.asu.edu.eg
Study Locations
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Cairo, Egypt, 11566
- Ain shams university
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Participants aged 60 years old and above both males and females
Exclusion Criteria:
o Patients with acute medical illness.
- Patients with life threatening illnesses.
- Bedridden patients.
- Patients with diagnosed malignancy.
- Patients with debilitating chronic disease (end organ failure) (e.g. heart failure , renal failure, and liver cell failure).
- Patients with neurological diseases (e.g. moderate to severe dementia, stroke, parkinsonism) that interfere with the assessment process.
- Patients with musculoskeletal conditions that interfere with the assessment process (fracture, disabling osteoarthritis, painful arthritis).
- Patients with severe uncorrected hearing loss, vision impairment, or aphasia that may impede effective communication during the assessment.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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cases
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
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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.
Other Names:
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control
age and gender matched elderly patients without fatigue
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The primary outcome measure the difference in cognitive performance between older adults with and without fatigue, assessed using the Montreal Cognitive Assessment (MoCA)
Time Frame: 6 months
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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.
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6 months
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The primary outcome measure the difference in physical performance between older individuals with and without fatigue, assessed using 6 minutes walk test
Time Frame: 6 months
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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).
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6 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MS313/2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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