Physical and Cognitive Performance in Older Adults With Fatigue

NCT06509620 | Not Yet Recruiting DMC

• 1 other identifier: MS313/2024
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fatigue

Keywords

fatigue; older adult

Outcome Measures

Primary Outcomes (2)

• The primary outcome measure the difference in cognitive performance between older adults with and without fatigue, assessed using the Montreal Cognitive Assessment (MoCA)

  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.

  6 months

• The primary outcome measure the difference in physical performance between older individuals with and without fatigue, assessed using 6 minutes walk test

  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).

  6 months

Study Arms (2)

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

Other: Fatigue severity scale

control

age and gender matched elderly patients without fatigue

Other: Fatigue severity scale

Interventions

Fatigue severity scale OTHER

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.

Also known as: Modified Fatigue Impact Scale, MONTREAL COGNITIVE ASSESSMENT, 6 Minute walk test

cases; control

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Community dwelling elderly participants (caregivers of inpatients, attendants of primary care , elderly clubs and other community gatherings).

You may qualify if:

• Participants aged 60 years old and above both males and females

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11566, Egypt

Location

MeSH Terms

Conditions

Fatigue

Interventions

Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Central Study Contacts

Doha Rasheedy, MD

CONTACT

01001193544; doharasheedy@med.asu.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Geriatrics and Gerontology

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 19, 2024
• Study Start: August 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: May 1, 2025
• Last Updated: July 19, 2024

Record last verified: 2024-07

Locations

EG (1)