Feasibility of High-intensity Functional Exercise With Simultaneous Cognitive Challenge for Older People With Falls Risk
NCT06774508, Not applicable, Completed, Umeå University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Feasibility of High-intensity Functional Exercise With Simultaneous Cognitive Challenge for Older People With Falls Risk | ClinicalTrials.gov |
| NCT number | NCT06774508 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 33 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Umeå University | ClinicalTrials.gov |
| Conditions | Accidental Falls, Postural Balance, Gait, Cognition | ClinicalTrials.gov |
| Interventions | HIFE+cog, HIFE | ClinicalTrials.gov |
| First posted | 2025-01-14 | ClinicalTrials.gov |
| Last updated | 2026-10-09 | ClinicalTrials.gov |
Registered outcomes 25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Recruitment | Before intervention start | Rate of recruited participants, and sources for recruitment | ClinicalTrials.gov |
| Primary | Adherence | Through the 3-month intervention | Number of exercise sessions attended | ClinicalTrials.gov |
| Primary | Exercise intervention content and delivery | Through the 3-month intervention | Number of exercises, sets, repetitions, and intensity achieved measured using a standardized exercise diary completed by supervisors after each session | ClinicalTrials.gov |
| Primary | Retention | Through the 3-month intervention | Number of participants that completed follow-ups | ClinicalTrials.gov |
| Primary | Safety | Through the 3-month intervention period | Adverse events, including falls and discomfort reported during or between sessions by participants or supervisors, and measured using a standardized exercise diary completed by supervisors after each session | ClinicalTrials.gov |
| Primary | Balance and gait capacity | Baseline, 3 months | The Timed up and go (TUG) test, with and without cognitive task | ClinicalTrials.gov |
| Primary | Balance and gait capacity | Baseline, 3 months | The 4m forward gait speed test, with and without cognitive task | ClinicalTrials.gov |
| Primary | Balance and gait capacity | Baseline, 3 months | The 4m backward gait speed test | ClinicalTrials.gov |
| Primary | Balance and gait capacity | Baseline, 3 months | The Berg balance scale | ClinicalTrials.gov |
| Primary | Balance and gait capacity | Baseline, 3 months | The 30-s Chair stand test | ClinicalTrials.gov |
| Primary | Cognitive function | Baseline, 3 months | The Mindmore cognitive battery: Mental speed with The Symbol-Digit Processing test | ClinicalTrials.gov |
| Primary | Cognitive function | Baseline, 3 months | The Mindmore cognitive battery: Mental speed with The Reaction test I and II | ClinicalTrials.gov |
| Primary | Cognitive function | Baseline, 3 months | The Mindmore cognitive battery: Attention and executive function (shifting) with The Trail making test - Click (TMT-Click) | ClinicalTrials.gov |
| Primary | Cognitive function | Baseline, 3 months | The Mindmore cognitive battery: Short term- and working memory with The Corsi Block test | ClinicalTrials.gov |
| Primary | Cognitive function | Baseline, 3 months | The Mindmore cognitive battery: Executive function (inhibition) with The Stroop test | ClinicalTrials.gov |
| Primary | Cognitive function | Baseline, 3 months | The Mindmore cognitive battery: Executive function (verbal fluency) with The FAS test | ClinicalTrials.gov |
| Primary | Occupational performance | Baseline, 3 months | The Canadian Occupational Performance Measure (COPM) | ClinicalTrials.gov |
| Primary | Experiences of the intervention and effects | 3 months | Individual interviews with participants in the intervention group | ClinicalTrials.gov |
| Secondary | Fear of falling | Baseline, 3 months | The Falls Self-Efficacy Scale (FES-I) | ClinicalTrials.gov |
| Secondary | Psychological wellbeing | Baseline, 3 months | The Philadelphia Geriatric Center Morale Scale (PGCMS) | 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 |
|---|---|---|
| Corsi Block-Tapping Test | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Verbal Fluency | Primary 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)