High Intensity Interval Training (HIIT) to Reduce Frailty and Enhance Resilience in Older Veterans
NCT05625204, Not applicable, Recruiting, VA Office of Research and Development
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | High Intensity Interval Training (HIIT) to Reduce Frailty and Enhance Resilience in Older Veterans | ClinicalTrials.gov |
| NCT number | NCT05625204 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 200 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | VA Office of Research and Development | ClinicalTrials.gov |
| Conditions | Frailty | ClinicalTrials.gov |
| Interventions | Center based attention (stretching only) control, Center based HIIT, Home based HIIT | ClinicalTrials.gov |
| First posted | 2022-11-22 | ClinicalTrials.gov |
| Last updated | 2025-12-12 | ClinicalTrials.gov |
Registered outcomes 28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Sub-maximal oxygen uptake test (VO2max) | Change from baseline to endpoint at 12 weeks | Participants are asked to exercise on an upright exercise bike as the resistance increases over time. During the exercise, participants are asked to breath through a mask that is connected to a oxygen and carbon dioxide measuring device. The assessment last for approximately 5-10 minutes and provides data the pertain to an individuals lung capacity, breathing rate, and endurance. | ClinicalTrials.gov |
| Secondary | Cognitive screen - SLUMS | Change from baseline to endpoint at 12 weeks | Cognitive status will be assessed using the VA - St. Louis University Mental Survey (VA-SLUMS) involving memory tests, shape recognition, and story recall. The survey scores range from 0-30, with a higher score representing greater cognitive capability. The investigators will also utilize the Cognivue to assess cognition. This is a combinatorial visual and reaction time test. | ClinicalTrials.gov |
| Secondary | Amyloid beta 42/40 ratio | Change from baseline to endpoint at 12 weeks | Serum cognitive marker: change in amyloid beta 42/40 ratio (a unitless measure derived from the ratio of serum amyloid-beta 42 in picograms per milliliter divided by serum amyloid-beta 40 in picograms per milliliter) from baseline to endpoint after 12 weeks. | ClinicalTrials.gov |
| Secondary | Cognitive screen - Cognivue | Change from baseline to endpoint at 12 weeks | Cognivue to assess cognition. This is a computer based combinatorial visual and reaction time test, which is scored 0 to 100. | ClinicalTrials.gov |
| Secondary | Phosphorylated tau (P-tau) | Change from baseline to endpoint at 12 weeks | Serum cognitive marker: plasma levels of phosphorylated tau (P-tau) in picograms per milliliter from baseline to endpoint after 12 weeks. | ClinicalTrials.gov |
| Secondary | Brain Derived Neurotrophic Factor (BDNF) | Change from baseline to endpoint at 12 weeks | Serum cognitive marker: change in Brain Derived Neurotrophic Factor (BDNF) in picograms per milliliter from baseline to endpoint after 12 weeks. | ClinicalTrials.gov |
| Secondary | Fatigue | Change from baseline to endpoint at 12 weeks | Fatigue as assessed by the Brief Fatigue Inventory, which contains 9 self-rated questions with an aggregate score range of 0 to 90. | ClinicalTrials.gov |
| Secondary | Sleep quantity and stages | Change from baseline to endpoint at 12 weeks | Objectively measure sleep quantity and stages using FITBIT Charge 5 actigraphy devices. These devices are worn on the wrist and sleep metrics, including total sleep time and time spent in light, deep, and REM sleep stages. | ClinicalTrials.gov |
| Secondary | Sleep quality | Change from baseline to endpoint at 12 weeks | Sleep quality as assessed by Pittsburgh Sleep Quality Index (PSQI). The PSQI contains 19 self-rated questions that combined to form 7 component scores, each with a range of 0 to 3 points. These in turn are added to yield a global score with a range of 0 to 21 points. | ClinicalTrials.gov |
| Secondary | Sleep chronotype | Change from baseline to endpoint at 12 weeks | Sleep chronotype as assessed by the Morningness/Eveningness survey, which contains 19 self-rated questions with an aggregate score range of 19 to 72. | ClinicalTrials.gov |
| Secondary | Sleepiness | Change from baseline to endpoint at 12 weeks | Sleepiness as assessed by the Epworth Sleepiness Scale, which contains 8 self-rated questions with an aggregate score range of 0 to 24. | ClinicalTrials.gov |
| Secondary | Insomnia | Change from baseline to endpoint at 12 weeks | Insomnia as assessed by the Insomnia Severity Index, which contains 7 self-rated questions with an aggregate score range of 0 to 28. | ClinicalTrials.gov |
| Secondary | Anxiety and depression | Change from baseline to endpoint at 12 weeks | Anxiety and depression as assessed by the Hospital Anxiety and Depression Scale (HADS), which contains 14 self-rated questions with an aggregate score range of 0 to 21. | ClinicalTrials.gov |
| Secondary | Sleep disorders | Change from baseline to endpoint at 12 weeks | Sleep disorders as assessed by the Holland Sleep Disorders Questionnaire, which contains 32 self-rated questions with an aggregate score range of 32 and 160. | ClinicalTrials.gov |
| Secondary | 30 second chair rise test | Change from baseline to endpoint at 12 weeks | The investigators will measure endurance in participants by asking participants to sit and rise repeated from a chair as many times in a 30 second time frame. | ClinicalTrials.gov |
| Secondary | Frailty assessment | Change from baseline to endpoint at 12 weeks | Frailty is a syndrome marked by greater susceptibility to adverse outcomes like falls and disability. The investigators will be using the Fried Frailty Phenotype that includes: 1) unexpected weight loss of 5% or more in the last year or BMI \< 18.5; score 0 or 1 if positive, 2) grip strength with BMI dependent cut points for men and women; score 0 or 1 if positive, 3) gait speed with height and sex dependent cutoffs; score 0 or 1 if positive, 4) activity assessed by a survey of the frequency of mild/moderate/energetic physical activity; score of 0 or 1, the latter if positive for hardly ever or never engaging in moderate or energetic physical activity, and 5) endurance assessed by survey of bed rest during the day; score of 0 or 1, the latter if occurring every day or every week. The composite score is therefore 0 to 5. | ClinicalTrials.gov |
| Secondary | Gait speed | Change from baseline to endpoint at 12 weeks | Participants are asked to perform a timed walk of approximately 15 feet in length | ClinicalTrials.gov |
| Secondary | Arm curl endurance | Change from baseline to endpoint at 12 weeks | Participants will receive a free weight (8lbs for men and 5lbs for women) and asked to perform total number of arm curls in 30 seconds while in a seated position. | ClinicalTrials.gov |
| Secondary | Quality of life assessment | Change from baseline to endpoint at 12 weeks | Quality of life assessment is performed using the Quality of life, enjoyment, and satisfaction questionnaire - short form (Q-LES-Q-SF) survey instrument. The survey instrument scores from 0 to 70 with a greater score representing better quality of life. | ClinicalTrials.gov |
| Secondary | Body Composition (Lean and fat mass) | Change from baseline to endpoint at 12 weeks | Body composition will be measured using bioelectric impedance (BIA) - a technique where participants are asked to stand on the measurement device and hold on to two metal handles. A light - and non-detectable - current is then transmitted allowing for collection of body fat and lean mass in the subject. The assessment takes roughly 2-3 minutes. | 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 2
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 |
|---|---|---|
| Short Story Recall | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | 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)