Trial · NCT06801808
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hand grip strenght test (HGST) | Change from Baseline HGT at 8 and 16 weeks | HGT is a test performed with a dynamometer, which goes to assess muscle strength (in kilograms). Starting with the elbow flexed to 90° the patient must squeeze the dynamometer as hard as they can at one time. Three repeated measurements are taken on each side 20 seconds apart. The average of the three assessments is used as the final value. |
| Secondary | Short Physical Performance Battery (SPPB) | Change from Baseline SPPB at 8 and 16 weeks | SPPB is a set of clinical tests used to assess physical performance, particularly lower extremity strenght and functional capacity in older adults. It includes three main components: balance (feet side-by-side, semitandem, and tandem positions), gait speed (time spent to walk 4m), and chair stand tests (five times chair sit-to-stand test). Each test is scored on a scale from 0 to 4, with higher scores indicating better performance. The total score ranges from 0 to 12, with higher scores reflecting better overall physical function. |
| Secondary | Time Up&Go Test (TUG) | Change from Baseline TUG at 8 and 16 weeks | TUG measures in seconds the time it takes a subject to rise from a chair, walk a distance of 3 meters, turn, walk back to the chair and sit down. The performance is rated on a scale of 1 to 5 (where 1 is normal and 5 is severely abnormal) according to the observer's perception of the patient's risk of falling. The timed part of the test records the mean time (in seconds) from initial getting up to re-seating. Patients are compared with the mean time of adults in their age group, 60 to 69, 70 to 79, and 80 to 99 years of age. |
| Secondary | Timed 25 Foot Walk (T25FW) | Change from Baseline T25FW at 8 and 16 weeks | The T25FW is a performance- based test used to measuere walking speed and mobility. The individuals is asked to walk a distance of 25 feet (approximately 7.62 meters) as quickly and safely as possible, with or without the use of assistive devices. The time taken to complete the walk is recorded, and the test is typically performed twice to ensure accuracy. |
| Secondary | Trial Making Test (TMT) | Change from Baseline TMT at 8 and 16 weeks | The TMT measueres flexibility of thinking on a visual-motor sequencing task. It consist of two parts, A and B where 25 circles distributed over a sheet paper. In part A, the circles are numbered 1-25, and the patient should draw lines to connect the numbers in ascending order. In part B, the circles include both numbers (1-13) and letters (A-L9: as pattern, but with the added task of alternating between the numebrs and lettes (i.e., 1-A-2-b-3-C, etc.). Results for both TMT A and B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Trail A: Average 29 seconds, deficient\> 78 seconds, Rule of Thumb most in 90 seconds. Trial B: Averange 75 seconds, deficient\> 273 seconds, Rule of Thumb most in 3 minutes |
| Secondary | Symbol Digit Modalities Test (SDMT) | Change from Baseline SDMT at 8 and 16 weeks | The SDMT is a neuropsycological test used to assess cogntive processing speed, attention, and visual-motor coordination. The test involves matching symbols to corresponding numbers based on a key, and participants must quickly and accurately pair the symbols with the correct numbers within a set time limit. The test evaluates attention, working memory, and mental flexibility. A higher score indicates better cognitive processing speed and accuracy. |
| Secondary | Stroop colour Word Test (SCWT) | Change from Baseline SCWT 8 and 16 weeks | The SCWT is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect. The subject is asked to read the words in the first task, to name colors in the second and third tasks. It is necessary to mark both any mistakes made but also the time spent on each task. The cut-off for the error interference effect is 4.24, while the cut-off for the time interference effect is 36.92. |
| Secondary | Hospital Anxiety and depression scale (HADS) | Change from Baseline SCWT 8 and 16 weeks | The Hospital Anxiety and Depression Scale (HADS) is a tool used to check for symptoms of anxiety and depression, especially in hospital patients. It has 14 questions, 7 for anxiety and 7 for depression. Each question is scored from 1 to 4. |
| Secondary | Modified Fatigue Impact scale (MFIS) | Change from Baseline SCWT 8 and 16 weeks | The Modified Fatigue Impact Scale (MFIS) is a tool used to assess the impact of fatigue on a person's physical, cognitive, and psychosocial functioning. It consists of 21 items, each scored from 0 (never) to 4 (almost always), with higher scores indicating greater fatigue impact. The scale is divided into three subscales: physical, cognitive, and psychosocial, providing a comprehensive measure of how fatigue affects daily life. |
| Secondary | EuroQoL-5D (EQ-5D) | Change from Baseline SCWT 8 and 16 weeks | EQ-5D is an instrument which evaluates the generic quality of life. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers given to ED-5D permit to find 243 unique health states or can be converted into EQ- 5D index an utility scores anchored at 0 for death and 1 for perfect health. |
| Secondary | Mini Nutritional Assessment- short Form (MNA-SF) | Change from Baseline SCWT 8 and 16 weeks | The Mini Nutritional Assessment - Short Form (MNA-SF) is a screening tool used to quickly evaluate the risk of malnutrition in older adults. It consists of 6 questions covering aspects such as weight loss, appetite, mobility, psychological stress, and body mass index (BMI) or calf circumference. Scores range from 0 to 14, with 12-14 indicating normal nutrition, 8-11 at risk of malnutrition, and 0-7 indicating malnutrition. |
| Secondary | SARC-F | Change from Baseline SCWT 8 and 16 weeks | The SARC-F is a simple screening tool used to identify individuals at risk of sarcopenia. It consists of 5 questions assessing strength, assistance with walking, rising from a chair, climbing stairs, and falls. Each item is scored from 0 to 2, with a total score ranging from 0 to 10. A score of 4 or higher suggests a risk of sarcopenia and the need for further assessment. |
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.
For software
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