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PARKINSON DISEASE (Disorder)LifeLikeNCT07485218

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

An observational study of PARKINSON DISEASE (Disorder) and Aged 65 Years or Older, run by University of Applied Sciences and Arts of Southern Switzerland at 5 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
How many people
120 participants
Where
5 sitesin 2 countries
Study dates
17 Dec 2024to Mar 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

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].

Who may be able to join

  • Age greater than 65 years.

Who cannot join

  • 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);
Show all 15Show fewer
  • 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).

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

Switzerland4 sites

  • Multistruttura Sezione Anziani

    Bellinzona, Canton Ticino, 6500

  • University of Applied Sciences and Arts of Southern Switzerland

    Manno, Canton Ticino, 6928

  • Fondazione Parco San Rocco

    Morbio Inferiore, Canton Ticino, 6834

  • Fondazione Opera Charitas

    Sonvico, Canton Ticino, 6968

Other trials in Switzerland

Italy1 site

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

    Milan, MI, 20132

Other trials in Italy

About this study

Official title: muLtidimensIonal Fatigability Assessment in oldEr aduLts of the Canton of Ticino and Elderly wIth parKinson's diseasE

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.

Read more
  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. In 2015, the Pittsburgh Fatigability Scale (PFS) was developed as a self-administered questionnaire to assess both physical and mental fatigue in older adults. The PFS consists of 10 questions describing activities of varying duration and intensity. The other scale the investigators will ask participants to complete is called the Fatigue Severity Scale (FSS): a 9-item questionnaire that evaluates fatigue intensity in various situations over the past week. Participants' fatigue will also be assessed during two motor tasks simulating daily activities: a handgrip test and a seated leg exercise mimicking walking. If participants decide to take part in our research project, participants will complete the PFS and FSS questionnaires once (5-10 minutes) and perform two brief motor exercises to determine the onset and progression of muscle fatigue. The exercises will last about 20 minutes, with an additional 10 minutes for preparation. Each contraction will last a maximum of 2 minutes. The project will last 12 months (Swiss section) and will be conducted at [(1) the nursing homes of the Multistruttura di Bellinzona, the Fondazione Parco San Rocco facilities in Morbio Inferiore and Coldrerio, and the Opera Charitas nursing home in Sonvico] (period: December 2024 - May 2025); and (2) at the [San Raffaele University Research Institute] in Milan, Italy, where 40 older adults with Parkinson's disease will participate (September 2026 - March 2027). This research project is conducted in accordance with Swiss legislation and current international ethical guidelines. It has been reviewed and approved by the Ethics Committee of the Canton of Ticino.
  2. Study procedure

The testing session will last a maximum of 30 minutes and will include the following steps:

Discussion of the study procedures.

Verification of appropriate leg clothing. The exercise can be performed either by wearing shorts or by rolling up long trousers to expose the upper half of the thigh.

Review of the completed Pittsburgh Fatigability Scale (PFS) questionnaire and completion of the Fatigue Severity Scale (FSS), both available in Italian.

Performance of two motor exercises (a surrogate walking test and a handgrip test).

  1. First, participants will be instructed on how to perform the surrogate walking test, which evaluates leg muscle fatigue. During the exercise, participants will push with their legs and foot on a movable platform that slides along rails within the device. The sliding motion is resisted by elastic bands that stretch and shorten as participants push. The exercise will be repeated for several cycles until participants are told to stop. To measure muscle fatigue, surface electrodes (non-invasive) will be placed on the skin over two thigh muscles.
  2. 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.
Read the detailed description

The principal investigator and the investigators at the local sites have approved the protocol version 1.2 dated 3/1/2024 and confirm to conduct the project according to the protocol, the Swiss legal requirements, the current version of the World Medical Association Declaration of Helsinki and the principles and procedures for integrity in scientific research involving human beings.

The multidimensional evaluation of fatigability will be conducted with (Site 1) older residents at the Charitas Foundation (TI, Switzerland), (Site 2) Multistruttura Sezione Anziani of the City of Bellinzona (TI, Switzerland), (Site 3) Parco San Rocco Foundation (TI, Switzerland); and (Site 4) active older people recruited at gym courses held by Pro Senectute Ticino and Moesano (TI, Switzerland). These participants will serve as controls for the matched participants with Parkinson's Disease (PD) that will be recruited at the (Site 5) University hospital San Raffaele, Milan (Italy).

The planned measures comprise supervised motor tasks and self-assessment questionnaires. Participants will be instructed and supervised during the exercises. Therefore, no risks of the procedure have been identified. The selected measures entail only minimal risks and burdens for the participants.

  1. Study design: Cross-sectional observational study in older people (active community-dwelling and residential in a nursing home, and outpatients with Parkinson's disease (PD)). Treatments are not affected by this study. The project setup is multicenter and international, with four sites in Switzerland, and one site in Italy. A cross-sectional study is appropriate to measure at one given point the variables of interest in different populations. The control group will give comparative scores about fatigability in older adults with PD. Participants at Sites 1-4 were recruited through study presentation meetings, which took place at nursing homes and gyms where physical exercise sessions for older adults were organized. Participants at Site 5 will be recruited at the San Raffaele Hospital.
  2. Procedures: A single measurement session, in a dedicated space, on the arranged date/hour, will be held.

After the candidate has signed the informed consent, the data listed below will be collected, by interview (I), and from clinical records (CR), prior to the enrolment in the study:

  • Sociodemographic information (age, gender, height, weight) (CR);
  • Information about any disabilities (CR);
  • Concurrent illnesses (CR);
  • Concurrent symptoms, directly reported by the patient (I);
  • Main drug treatments that may interfere with the fatigue level (CR).

After the enrolling of the subject in the study, the following procedures will be performed:

  1. Assessment of physical and mental perceived fatigability: before performance measurements, the participants will be asked to complete the PFS-Italian version and the Fatigue Severity Scale (FSS). The proposed questionnaires are validated Italian versions. All the procedures are highly standardized; thus, the expected bias should be negligible. ii) Physical performance measurements: the repetitive hand-grip test will be performed in a sitting position, with the arm at 90° of flexion and wrist positioned in a supine position and neutral wrist posture. The hand-grip task will be performed using the force fiber Optic Response Pad used in fMRI, grip force transducer (fORP 932 Package, Current Designs, Philadelphia, USA).

The fatiguing protocol of upper and lower limbs will be characterized by the following contractions:

  • Two maximal isometric contractions (MVC) of 3-4 s.
  • An isometric contraction at 20% MVC lasting 20 s.
  • A dynamic series of contractions lasting 120 s.
  • An isometric contraction at 20% MVC lasting 20 s.
  • A maximal isometric contraction (MVC) of 3-4 s Participants will perform active knee extension and flexions, cadenced using a metronome with a foot drive device called Minivector® (Easytech, Borgo San Lorenzo, Italy) placed on the floor and fixed with straps to the chair. Participants will be instructed to move the foot platform between a fixed range. The Minivector is a class I CE certified medical device (UE Regulation 2017/745).

Performance fatigability will be assessed by means of surface electromyography (sEMG) electrodes placed on the vastus medialis (VM) and vastus lateralis (VL) muscles. Surface EMG signals will be recorded with electrodes applied on the skin overlying the muscles as previously described.

Keywords
Aged, Parkinson Disease, Aging in Place, Nursing Home Residents, Muscle Strength Dynamometer, Fatigue
Medical subject headings
Parkinson Disease, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07485218
Study groupRoleWhat they receive
Nursing homes OANo intervention. Older adults living in a nursing home located in southern Switzerland and with an age greater than 80 years.
Community-dwelling OANo intervention. Older adults living at their homes with an age comprised between 65 and 75 years.
PD OAOlder outpatients with early phases of Parkinson's Disease, with age greater than 65 years.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Baseline

  3. 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.

    Measured: Baseline

  4. EMG variables

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

    Measured: Baseline

  5. Torque

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

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2026
  2. Study start17 Dec 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07485218
Sponsor's protocol ID
40RALifelike
Acronym
LifeLike
Status last verified
Mar 2026
First submitted
10 Mar 2026
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 6067254

  • 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.

    PubMed 14044222

  • 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.

    PubMed 8014392

  • 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.

    PubMed 1159263

  • 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.

    PubMed 31972554

  • 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.

    PubMed 39702098

  • 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.

    PubMed 31147224

Questions about this trial

What is this clinical trial studying?

An observational study of PARKINSON DISEASE (Disorder) and Aged 65 Years or Older, run by University of Applied Sciences and Arts of Southern Switzerland at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Switzerland, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS_mental subscale (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07485218, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

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