Trial · NCT07907302
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Handgrip Strength | Baseline (T0), immediately after the 12-week intervention (T1), and 4 weeks after intervention completion (T2). | Handgrip strength will be assessed using handgrip dynamometry as a measure of muscle strength within the EWGSOP2 sarcopenia assessment framework. Higher values indicate greater muscle strength. |
| Primary | Physical Performance - Short Physical Performance Battery (SPPB) | Baseline (T0), immediately after the 12-week intervention (T1), and 4 weeks after intervention completion (T2). | Physical performance will be assessed using the Short Physical Performance Battery (SPPB), which evaluates balance, gait speed, and lower-limb functional performance. The total score ranges from 0 to 12 points, with higher scores indicating better physical performance. |
| Primary | Body Composition -Body fat (%) | Baseline (T0), immediately after the 12-week intervention (T1), and 4 weeks after intervention completion (T2). | It will be assessed assessed using bioelectrical impedance analysis (BIA) , measured in %. |
| Primary | Body Composition -Body fat (kg) | Baseline (T0), immediately after the 12-week intervention (T1), and 4 weeks after intervention completion (T2). | It will be assessed assessed using bioelectrical impedance analysis (BIA), measured in kg. |
| Primary | Body Composition -Lean mass (kg) | Baseline (T0), immediately after the 12-week intervention (T1), and 4 weeks after intervention completion (T2). | It will be assessed assessed using bioelectrical impedance analysis (BIA) , measured in kg. |
| Primary | Body Composition -Lean mass (%) | Baseline (T0), immediately after the 12-week intervention (T1), and 4 weeks after intervention completion (T2). | It will be assessed assessed using bioelectrical impedance analysis (BIA) , measured in %. |
| Primary | Body Composition -body water(%) | Baseline (T0), immediately after the 12-week intervention (T1), and 4 weeks after intervention completion (T2). | It will be assessed assessed using bioelectrical impedance analysis (BIA) , measured in %. |
| Primary | Body Composition -body water(kg) | Baseline (T0), immediately after the 12-week intervention (T1), and 4 weeks after intervention completion (T2). | It will be assessed assessed using bioelectrical impedance analysis (BIA) , measured in kg. |
| Secondary | Functional Mobility - Timed Up and Go (TUG) | Baseline (T0), immediately after the 12-week intervention (T1), and 4 weeks after intervention completion (T2). | Functional mobility will be assessed using the Timed Up and Go (TUG) test. The time required to stand up from a chair, walk 3 meters, turn, walk back, and sit down will be recorded in seconds. Lower completion times indicate better functional mobility. |
| Secondary | Sarcopenia Risk - SARC-F | Baseline (T0), immediately after the 12-week intervention (T1), and 4 weeks after intervention completion (T2). | Sarcopenia risk will be assessed using the SARC-F questionnaire, which evaluates strength, assistance with walking, rising from a chair, climbing stairs, and falls. The total score ranges from 0 to 10 points, with higher scores indicating greater risk of sarcopenia. |
| Secondary | Calf Circumference | Baseline (T0), immediately after the 12-week intervention (T1), and 4 weeks after intervention completion (T2). | Calf circumference will be measured as an anthropometric indicator related to muscle mass and sarcopenia. Measurements will be recorded in centimeters, with higher values indicating greater calf circumference. |
| Secondary | Parkinson's Disease Severity - Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | Baseline (T0), immediately after the 12-week intervention (T1), and 4 weeks after intervention completion (T2). | Parkinson's disease-related motor and non-motor symptoms will be assessed using the MDS-UPDRS Parts I-IV. The scale evaluates non-motor experiences of daily living (Part I), motor experiences of daily living (Part II), motor examination (Part III), and motor complications (Part IV). Higher scores indicate greater disease-related impairment or severity. |
| Secondary | Number of Falls | Baseline (T0), throughout the 12-week intervention period, and at the 4-week post-intervention follow-up (T2). | Falls occurring during the study period will be recorded as part of the clinical and functional assessment. The number of falls reported by each participant will be documented, with a higher number indicating a greater occurrence of falls. |
| Secondary | Nutritional Status - Mini Nutritional Assessment-Short Form (MNA-SF) | Baseline (T0), immediately after the 12-week intervention (T1), and 4 weeks after intervention completion (T2). | Nutritional status will be assessed using the Mini Nutritional Assessment-Short Form (MNA-SF). The total score ranges from 0 to 14 points, with higher scores indicating better nutritional status and lower scores indicating greater risk of malnutrition. |
| Secondary | Malnutrition Risk - Malnutrition Screening Tool (MST) | Baseline (T0), immediately after the 12-week intervention (T1), and 4 weeks after intervention completion (T2). | Risk of malnutrition will be assessed using the Malnutrition Screening Tool (MST), which considers recent unintentional weight loss and reduced food intake related to decreased appetite. Higher scores indicate greater risk of malnutrition. |
| Secondary | Self-Reported Swallowing Difficulties - Eating Assessment Tool-10 (EAT-10) | Baseline (T0), immediately after the 12-week intervention (T1), and 4 weeks after intervention completion (T2). | Self-reported swallowing difficulties will be assessed using the Eating Assessment Tool-10 (EAT-10), a 10-item questionnaire evaluating symptoms related to swallowing. The total score ranges from 0 to 40 points, with higher scores indicating greater self-perceived swallowing difficulties. |
| Secondary | Neurocognitive Status According to DSM-5 Criteria | Baseline (T0), immediately after the 12-week intervention (T1), and 4 weeks after intervention completion (T2). | Neurocognitive status will be clinically classified according to DSM-5 criteria into one of three categories: normal cognition, mild neurocognitive disorder, or major neurocognitive disorder. Neurocognitive classification will be used to characterize participants and explore its potential influence on response to the intervention and tolerance to cognitive-motor dual-task training. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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