Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT03963050
Eligibility Criteria:
Inclusion Criteria:
* YH: 30 healthy young (20-25 years old) participants. They must be free of any disease.
* OH: 30 healthy oldest old (80-90 years old) participants. They must be free of any neural or physical disease and any severe chronic disease (CODP, Heart Failure) that can compromise exercise.
* PF: 30 oldest old (80-90 years old) participants. They must be characterized by functional deficits (sarcopenia, osteoporosis and muscle weakness) without cognitive impairment. Additionally, participants cannot be affected by any severe chronic disease that compromise exercise.
* CF: 30 oldest old (80-90 years old) participants. They must be characterized by mild cognitive impairment (MCI) and subjective cognitive decline without functional deficits. Additionally, participants cannot be affected by any severe chronic disease that compromise exercise.
Exclusion Criteria YH
* Any medication
* Any disease
* General: pregnancy, addictive or previous addictive behavior defined as the abuse of cannabis, opioids or other drugs, carrier of infectious diseases.
* For TMS: Epilepsy, metallic prosthesis, malignant tumor
Exclusion Criteria OH
* Heart failure, angina, pulmonary disease.
* Cognitive frailty (MCI, Alzheimer) or physical frailty (musculoskeletal diseases)
* General: coagulation disorders, pregnancy, addictive or previous addictive behavior defined as the abuse of cannabis, opioids or other drugs, carrier of infectious diseases, suffering from musculoskeletal diseases, suffering from mental illness, inability to cooperate, subjects suffering from known cardiac conditions (e.g., pacemakers, arrhythmias, and cardiac conduction disturbances) or peripheral neuropathy. Moreover, subjects suffering from diabetes, arthritis and under medication will be scored according to specific criteria.
* Assumption of any anticoagulant medication
* Assumption of antiplatelet medications in high dose (es: acetylsalicylic acid \>200mg x day)
* For TMS: Epilepsy, metallic prosthesis, malignant tumor
* For MRI: pacemaker, internal defibrillator or other ferromagnetic implants
Exclusion Criteria PF
* Simultaneous presence of physical frailty and cognitive impairment (CDR=0.5)
* For exercise testing and training: heart failure, angina, pulmonary disease.
* General: coagulation disorders, pregnancy, addictive or previous addictive behavior defined as the abuse of cannabis, opioids or other drugs, carrier of infectious diseases, suffering from musculoskeletal diseases, suffering from mental illness, inability to cooperate, subjects suffering from known cardiac conditions (e.g., pacemakers, arrhythmias, and cardiac conduction disturbances) or peripheral neuropathy. Moreover, subjects suffering from diabetes, arthritis and under medication will be scored according to specific criteria.
* The T-scores for the whole body and PA-projection total spine parameters: According to the World Health Organization (WHO) recommendation, participants will be diagnosed as having osteoporosis when the minimum T-score, measured at any site, will be less than -2.5, osteopenia if T-score between -1 and -2.5 and normal if T-score will be greater than -1 according to the World Health Organization guideline. Diagnosis will be made on basis of lowest T score at any measured site (T score ≥-1 SD = Normal; T score between -1 and -2.5 SD = Low bone mass, and T Score ≤-2.5 SD = Osteoporosis). T-score reference values are provided by the DXA scanner manufacturer.
* Assumption of any anticoagulant medication
* Assumption of antiplatelet medications in high dose (es: acetylsalicylic acid \>200mg x day)
* For TMS: Epilepsy, metallic prosthesis, malignant tumor
* For MRI: pacemaker, internal defibrillator or other ferromagnetic implants
* Decline a priori to participate in the intervention Phase 2 of the study
* Cut-off exclusion criteria of PF:
* Fried's Frailty Phenotype: \< 3 positive characteristics
* Timed-up-and-go test: \<10 sec
* The Multidimensional Prognostic Instrument (MPI): \< 0.66 score
* The GAITRite system: \> 0.9 m/s
* Groningen Frailty Indicator: \<4
Exclusion Criteria CF
* Simultaneous presence of physical frailty and cognitive impairment (CDR=0.5)
* For exercise testing and training: heart failure, angina, pulmonary disease.
* General: coagulation disorders, pregnancy, addictive or previous addictive behavior defined as the abuse of cannabis, opioids or other drugs, carrier of infectious diseases, suffering from musculoskeletal diseases, suffering from mental illness, inability to cooperate, subjects suffering from known cardiac conditions (e.g., pacemakers, arrhythmias, and cardiac conduction disturbances) or peripheral neuropathy. Moreover, subjects suffering from diabetes, arthritis and under medication will be scored according to specific criteria.
* The T-scores for the whole body and PA-projection total spine parameters: According to the World Health Organization (WHO) recommendation, participants will be diagnosed as having osteoporosis when the minimum T-score, measured at any site, will be less than -2.5, osteopenia if T-score between -1 and -2.5 and normal if T-score will be greater than -1 according to the World Health Organization guideline. Diagnosis will be made on basis of lowest T score at any measured site (T score ≥-1 SD = Normal; T score between -1 and -2.5 SD = Low bone mass, and T Score ≤-2.5 SD = Osteoporosis). T-score reference values are provided by the DXA scanner manufacturer.
* Assumption of any anticoagulant medication
* Assumption of antiplatelet medications in high dose (es: acetylsalicylic acid \>200mg x day)
* For TMS: Epilepsy, metallic prosthesis, malignant tumor
* For MRI: pacemaker, internal defibrillator or other ferromagnetic implants
* Decline a priori to participate in the intervention Phase 2 of the study
* Cut-off exclusion criteria of CF:
* Mini Mental State (MMSE): cut-off 23.8
* FCSRT: IFR (immediate free recall) cut off \<19.59; ITR (immediate total recall) cut off\<35; DFR (delayed free recall) cut off \<6.31; DTR (delayed total recall) cut off\<11; index of sensitivity of cueing cut off\<0.9; Number of intrusions cut off\>0
* Digit Span: cut off 3.75
* Digit Span Reversal (WAIS): cut off 2.65
* Rey-Osterrieth Complex Figure Test: cut off copy 28.88 - cut off
* deferred reproduction 9.47
* Trial Making Test A(ENB2): cut off \>93 sec; TMT B (ENB2): cut off \>282 sec; TMT B-A (ENB2): cut off\>186 sec
* Frontal Assessment Battery (FAB): cut off \<13.4
* Phonemic Fluency (ENB2): cut off 3
* Clock Test: cut off \<6.25
* Time up and Go TUG-COG: cut off \>15sec
* Cognitive Function Instrument (partly for the caregiver): no cut-off
* Neuropsychiatric Inventory (for the caregiver): cut-off \>0
* Geriatric Depression Scale: cut-off\>10
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
80 Years
Maximum Age:
90 Years
Study:
NCT03963050
Study Brief:
Protocol Section:
NCT03963050