Physical and Cognitive Performance in Older Adults With Fatigue

July 17, 2024 updated by: Doha Rasheedy, Ain Shams University

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

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Cairo, Egypt, 11566
        • Ain shams university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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:
  • 6 Minute walk test
  • Modified Fatigue Impact Scale
  • MONTREAL COGNITIVE ASSESSMENT
control
age and gender matched elderly patients without fatigue
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:
  • 6 Minute walk test
  • Modified Fatigue Impact Scale
  • MONTREAL COGNITIVE ASSESSMENT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

July 10, 2024

First Submitted That Met QC Criteria

July 17, 2024

First Posted (Actual)

July 19, 2024

Study Record Updates

Last Update Posted (Actual)

July 19, 2024

Last Update Submitted That Met QC Criteria

July 17, 2024

Last Verified

July 1, 2024

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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