Multidimensional Assessment of Fatigability in Older Adults Living in Southern Switzerland and Elderly With Parkinson's Disease

NCT07485218 | Active Not Recruiting

• 1 other identifier: 40RALifelike
• Study Type: observational
• Target: 120
• Locations: 2 countries
• Sites: 5

Brief Summary

With our study, the investigators aim to assess the impact of the fatigue experienced during daily life activities (tiredness) and whether there is a relationship with muscle fatigue during an exercise task. The results of this study may be used to improve the assessment of fatigue in older adults and enhance clinical management.

1. 1.General information An increase in fatigue is considered one of the main causes of reduced quality of life in older adults and in people suffering from chronic diseases. However, the investigators still know little about the mechanisms underlying fatigue in older adults, mainly because most of the available tools were developed to assess this symptom in younger populations with specific diseases, without proper adjustments for physical activity or age.
2. 2.Study procedure
3. 3.First, participants will be instructed on how to perform the surrogate walking test, which evaluates leg muscle fatigue.
4. 4.After a 5-minute rest, participants will be asked to perform the handgrip test with participants' right hand (see Figure 3). The maximal handgrip test will be performed while seated, with participants' forearm resting on a table. The test will be repeated several times until participants are instructed to stop.

Conditions

PARKINSON DISEASE (Disorder); Aged 65 Years or Older

Keywords

Aged; Parkinson Disease; Aging in Place; Nursing Home Residents; Muscle Strength Dynamometer; Fatigue

Outcome Measures

Primary Outcomes (5)

• PFS_mental subscale

  The score of the Pittsburgh Fatigability Scale (PFS) mental subscale. Mental Fatigability Score: Calculated by summing the mental fatigue rating for each activity (a-j). Score range (0-50) with higher score=greater mental fatigability.

  Baseline

• PFS_physical subscale

  The score of the physical subscale. Physical Fatigability Score: Calculated by summing the physical fatigue rating for each activity (a-j). Score range (0-50) with higher score=greater physical fatigability.

  Baseline

• FSS

  the total score of the Fatigue Severity Scale (FSS). Each question is graded on a 7-point Likert scale ranging from 1 ("completely disagree") to 7 ("completely agree"). Score range (9-63) with higher score=greater fatigue.

  Baseline

• EMG variables

  variables extracted from the surface EMG signal will be used to measure the variations of performance fatigability

  Baseline

• Torque

  Torque signal will be used to measure the intensity of performance fatigability

  Baseline

Study Arms (3)

Nursing homes OA

No intervention. Older adults living in a nursing home located in southern Switzerland and with an age greater than 80 years.

Community-dwelling OA

No intervention. Older adults living at their homes with an age comprised between 65 and 75 years.

PD OA

Older outpatients with early phases of Parkinson's Disease, with age greater than 65 years.

Eligibility Criteria

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

Study Population

Three cohorts: 1. Nursing homes OA 40 residents in a nursing home of southern Switzerland will be recruited. The study will not affect any treatment. The key inclusion criteria for the participants' eligibility will be age greater than 80 years, modified Barthel Index score ≥85 points \[Tofani et al., 2019\] and ADL index score ≤12 points \[Katz et al., 1963\]. 2. Community-dwelling OA 40 active community-dwelling older people will be recruited. The key inclusion criterion for the participants' eligibility is an age comprised between 65 and 75 years. 3. 40 older outpatients with early phases of PD will be recruited. People with PD fulfilling the key inclusion and the following criterium are eligible for this study (see above): • Primary parkinsonism stages I-III of clinical disability, according to Hoehn and Yahr \[1967\].

You may qualify if:

• Age greater than 65 years.

You may not qualify if:

• No understanding of the project language (Italian);
• Moderate to severe dementia, with a Short Portable Mental Status Questionnaire (SPMSQ) score ≥1 \[Pfeiffer, 1975\] or Cognitive Performance Scale (CPS) ≥3 \[Morris et al., 1994\];
• Psychiatric disorders and moderate neurodegenerative diseases;
• Delirium;
• Persistent infections;
• Inability to follow the study procedures (due to psychological disorders or dementia);
• Severe hearing problem;
• Unable or refuse to perform the physical tests (maximal handgrip strength, leg extension);
• Severe cardiovascular and lung diseases (acute infection, heart, or lung failure, unstable angina and myocardial infarction during the previous month);
• Renal failure, hepatic dysfunction;
• Recent major surgery;
• Severe cardiovascular exacerbations (RR \> 240/120, HR above the age predicted maximum of 220-Age);
• Participation in another study with investigational drug within the 30 days preceding and during the present study;
• Drug treatments that may interfere with the fatigue level;
• Lifestyle factors and / or persistent addictions (drug or alcohol abuse).

Sponsors & Collaborators

• University of Applied Sciences and Arts of Southern Switzerland: lead
• IRCCS Ospedale San Raffaele: collaborator

Study Sites (5)

Neuroimaging Research Unit, Division of Neuroscience San Raffaele Scientific Institute, Vita - Salute San Raffaele University

Milan, MI, 20132, Italy

Location

Multistruttura Sezione Anziani

Bellinzona, Canton Ticino, 6500, Switzerland

Location

University of Applied Sciences and Arts of Southern Switzerland

Manno, Canton Ticino, 6928, Switzerland

Location

Fondazione Parco San Rocco

Morbio Inferiore, Canton Ticino, 6834, Switzerland

Location

Fondazione Opera Charitas

Sonvico, Canton Ticino, 6968, Switzerland

Location

Related Publications (7)

• Hoehn MM, Yahr MD. Parkinsonism: onset, progression and mortality. Neurology. 1967 May;17(5):427-42. doi: 10.1212/wnl.17.5.427. No abstract available.

  PMID: 6067254 BACKGROUND

• KATZ S, FORD AB, MOSKOWITZ RW, JACKSON BA, JAFFE MW. STUDIES OF ILLNESS IN THE AGED. THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL FUNCTION. JAMA. 1963 Sep 21;185:914-9. doi: 10.1001/jama.1963.03060120024016. No abstract available.

  PMID: 14044222 BACKGROUND

• Morris JN, Fries BE, Mehr DR, Hawes C, Phillips C, Mor V, Lipsitz LA. MDS Cognitive Performance Scale. J Gerontol. 1994 Jul;49(4):M174-82. doi: 10.1093/geronj/49.4.m174.

  PMID: 8014392 BACKGROUND

• Pfeiffer E. A short portable mental status questionnaire for the assessment of organic brain deficit in elderly patients. J Am Geriatr Soc. 1975 Oct;23(10):433-41. doi: 10.1111/j.1532-5415.1975.tb00927.x.

  PMID: 1159263 BACKGROUND

• Beretta-Piccoli M, Cescon C, Barbero M, Villiger M, Clijsen R, Kool J, Kesselring J, Bansi J. Upper and lower limb performance fatigability in people with multiple sclerosis investigated through surface electromyography: a pilot study. Physiol Meas. 2020 Mar 6;41(2):025002. doi: 10.1088/1361-6579/ab6f54.

  PMID: 31972554 BACKGROUND

• Vercelli S, Zampogna E, Negrini F, Pietraroia C, D'Antona G, Papa S, Soldini E, Barbero M, Glynn NW, Beretta-Piccoli M. Cross-cultural translation, validation, and responsiveness of the Pittsburgh Fatigability Scale - Italian version (PFS-I) in a mixed-sample of older adults. BMC Geriatr. 2024 Dec 19;24(1):1016. doi: 10.1186/s12877-024-05603-z.

  PMID: 39702098 BACKGROUND

• Siciliano M, Chiorri C, De Micco R, Russo A, Tedeschi G, Trojano L, Tessitore A. Fatigue in Parkinson's disease: Italian validation of the Parkinson Fatigue Scale and the Fatigue Severity Scale using a Rasch analysis approach. Parkinsonism Relat Disord. 2019 Aug;65:105-110. doi: 10.1016/j.parkreldis.2019.05.028. Epub 2019 May 22.

  PMID: 31147224 BACKGROUND

Related Links

• Ordinance on Human Research with the Exception of Clinical trials (HRO)

MeSH Terms

Conditions

Parkinson Disease; Fatigue

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher and lecturer

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 20, 2026
• Study Start: December 17, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

IT (1); CH (4)