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NCT Number: 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.

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Key information

Conditions

Fatigue Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ain Shams University

Cairo, 11566, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Modified Fatigue Impact Scale, MONTREAL COGNITIVE ASSESSMENT, 6 Minute walk test

Primary outcomes

  1. 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.

  2. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Doha Rasheedy, MD

CONTACT

[email protected]

01001193544

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 19, 2024
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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