A Novel Multi-Modal Approach to Promote Functional Outcomes in Cognitively Frail Older Adults
NCT07497334, Not applicable, Recruiting, The Hong Kong Polytechnic University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Novel Multi-Modal Approach to Promote Functional Outcomes in Cognitively Frail Older Adults | ClinicalTrials.gov |
| NCT number | NCT07497334 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 45 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | The Hong Kong Polytechnic University | ClinicalTrials.gov |
| Conditions | Frailty at Older Adults, Mild Cognitive Impairment | ClinicalTrials.gov |
| Interventions | Theta burst stimulation, Aerobic exercise | ClinicalTrials.gov |
| First posted | 2026-03-27 | ClinicalTrials.gov |
| Last updated | 2026-09-30 | ClinicalTrials.gov |
Registered outcomes 18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Montreal Cognitive Assessment | Baseline, 3 months, and 6 months | General cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). The total MoCA score ranges from 0 to 30, with higher scores indicating better cognitive performance | ClinicalTrials.gov |
| Primary | Short Physical Performance Battery | Baseline, 3 months, and 6 months | Mobility will be assessed using the Short Physical Performance Battery (SPPB). The SPPB evaluates balance, gait speed, and chair stand performance, with total scores ranging from 0 to 12. Higher scores indicate better mobility | ClinicalTrials.gov |
| Primary | Pictorial Fit-Frail Scale | Baseline, 3 months, and 6 months | Frailty in older adults will be assessed using the Pictorial Fit-Frail Scale (PFFS). The PFFS evaluates 14 health domains, with total scores ranging from 0 to 43. Higher scores indicate a greater severity of frailty. | ClinicalTrials.gov |
| Secondary | Six Minutes Walking Test | Baseline, 3 months, and 6 months | The Six-Minute Walk Test (6MWT) is a practical, self-paced clinical test that measures the total distance an individual can walk on a flat, hard surface in six minutes. A longer distance walked reflects a higher level of functional mobility. | ClinicalTrials.gov |
| Secondary | Timed-Up-and-Go Test | Baseline, 3 months, and 6 months | The Timed Up and Go (TUG) test is a standardized assessment used to evaluate mobility and gait. A longer completion time reflects poorer physical mobility. | ClinicalTrials.gov |
| Secondary | Task Switch Test | Baseline, 3 months, and 6 months | The Task Switching Test is a standardized assessment used to evaluate executive function. A higher accuracy rate and a shorter reaction time reflect superior executive performance | ClinicalTrials.gov |
| Secondary | Digit Span Test | Baseline, 3 months, and 6 months | The Digit Span Test is a standardized neuropsychological assessment used to evaluate attention and working memory. The test comprises two components: Digits Forward and Digits Backward. A higher cumulative score reflects better overall performance. Additionally, a smaller discrepancy score (calculated as the forward span minus the backward span) represents superior cognitive manipulation and updating ability. | ClinicalTrials.gov |
| Secondary | Digit Symbol Substitution Test | Baseline, 3 months, and 6 months | The Digit Symbol Substitution Test (DSST) is a standardized neuropsychological instrument used to evaluate cognitive processing speed and executive function. The total score is determined by the number of correctly completed items within a specified time limit, with higher scores reflecting superior cognitive performance. | ClinicalTrials.gov |
| Secondary | Stroop Test | Baseline, 3 months, and 6 months | The Stroop Test is a standardized neuropsychological assessment used to evaluate executive function, particularly inhibitory control. The completion time for each condition is recorded as the score, with shorter completion times reflecting superior executive performance. | ClinicalTrials.gov |
| Secondary | Trail Making Test | Baseline, 3 months, and 6 months | The Trail Making Test will comprise Part A and Part B. In Part A, participants are instructed to connect numbers in sequential order (e.g., drawing a line from 1 to 2, 2 to 3, 3 to 4, etc.) while being timed. In Part B, participants are instructed to connect, in order, 25 encircled numbers and letters alternately (e.g., 1-A-2-B-3-C) while being timed. A longer time represents worse executive function. | ClinicalTrials.gov |
| Secondary | 30-second sit to stand | Baseline, 3 months, and 6 months | Functional mobility and lower-limb functional strength will be measured via the 30-Second Chair Stand Test (30CST). Participants stand up and sit down as rapidly and safely as possible for 30 seconds, where a higher repetition score indicates greater functional mobility. | ClinicalTrials.gov |
| Secondary | cortical and subcortical volume | Baseline, 3 months, and 6 months | Cortical and subcortical volume will be examined in all participants using MRI. Participants will undergo structural MRI on the 3T Siemens scanner at the University Research Facility in Behavioral and Systems Neuroscience. Participants will complete T1 and T2 high resolution anatomical scans. | ClinicalTrials.gov |
| Secondary | Resting State-Functional Connectivity-Functional MRI | Baseline, 3 months, and 6 months | Participants will be instructed to rest with eyes open for approximately 12 minutes. This will allow the investigators to examine activation in the resting state network. | ClinicalTrials.gov |
| Secondary | Physical Activity Scale for the Elderly | Baseline, 3 months, and 6 months | Physical activity will be assessed by Physical Activity Scale for the Elderly (PASE), where a higher score indicates a higher level of physical activity. | ClinicalTrials.gov |
| Secondary | Geriatric Depression Scale | Baseline, 3 months, and 6 months | Depression will be measured by Geriatric Depression Scale (GDS), where a higher score indicates a higher level of depressive symptoms | ClinicalTrials.gov |
| Secondary | Fatigue Severity Scale | Baseline, 3 months, and 6 months | Physical fatigue will be measured by Fatigue Severity Scale (FSS), where a higher score indicates more severe fatigue | ClinicalTrials.gov |
| Secondary | Functional Comorbidity Index | Baseline, 3 months, and 6 months | Total number of comorbid conditions will be assessed through the Functional Comorbidity Index (FCI), where a higher score indicates a greater comorbidity burden. | ClinicalTrials.gov |
| Secondary | Functional Activities Questionnaire | Baseline, 3 months, and 6 months | The difficulties in activities of daily living will be assessed using the Functional Activities Questionnaire (FAQ), with higher scores reflecting severe difficulty in performing daily tasks. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Task Switching Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)