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:
i) 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.
