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| ID | Type | Description | Link |
|---|---|---|---|
| RX002902 | Other Grant/Funding Number | Veteran Affairs |
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COVID pandemic halted ability to enroll participants. Grant funded then ended.
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| Name | Class |
|---|---|
| The VA Western New York Healthcare System | FED |
| University at Buffalo | OTHER |
| Roswell Park Cancer Institute | OTHER |
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Frailty is a clinical condition of poor physiological reserve that increases risks for adverse health outcomes including falls, hospitalization and mortality. Exercise is beneficial for the prevention and even reversal of frailty, yet participation among older individuals is limited. Short session high intensity interval training (HIIT) is emerging as a promising exercise strategy that achieves performance gains with lower time commitment. The goal of this pilot proposal is to establish the feasibility of HIIT exercise training protocols in 65-85 year old individuals, as well as to demonstrate the ability to detect functional and physiologic benefits. The investigators anticipate the preliminary research findings will lay the foundation for future human clinical studies that will permit us to significantly improve the health of Veterans.
Enhancing functional capacity in older adults with short session high intensity interval training
Frailty is a condition of poor physiological reserve that increases susceptibility to falls, hospitalization, disability and mortality. The incidence of frailty rapidly increases after the age 65, growing from 10% to as many as 50% of those 85 years or older; therefore over 9 million Veterans are either frail or at risk for frailty. Exercise has proven benefits for frailty, yet older adults rarely attain the recommended 150 minutes a week of moderate intensity exercise. High intensity interval training (HIIT) is emerging as an alternative as it delivers similar or better gains than moderate intensity exercise in less time. Recently, the investigators published that a 3-day-a-week, 10-minute HIIT regimen in aged mice not only reduces frailty, but leads to both strength and endurance benefits. In addition, the preliminary data demonstrate significant changes in microRNA (miRNA) profiles. Despite the potential of short session HIIT to improve functional capacity and lead to better adherence, the modality has not been tested in individuals 65-85 years of age, and in particular, frail individuals. The goals of this proposal are to: 1) investigate the feasibility of recruiting and administering short session HIIT to frail, pre-frail, and non-frail older Veterans and 2) to characterize the physical performance benefits and serum microRNA (miRNA) profiles in those participants.
To accomplish these goals the investigators will administer a short session HIIT regimen totaling only 10-minutes, 3-days-a-week for 3 months, using recumbent exercise cycles, to 65-85 year old participants. The investigators will also utilize next generation RNA sequence technology to assess HIIT impacts upon microRNA profiles in serum samples. The investigators anticipate this project will demonstrate the feasibility of administering short session HIIT to older individuals, including vulnerable frail and pre-frail populations as well as demonstrate the ability to collect and analyze serum miRNA profiles. The advantages to this program are the ability to maintain or build muscle mass and improve aerobic conditioning, especially in older patients where frailty and sarcopenia are so prevalent. This pilot project will therefore lay the foundation for future clinical trials that further explore the utility of HIIT to prevent or delay the onset of frailty in larger cohorts, and ultimately lead to the enhancement of functional capacity and quality of life in aging Veteran populations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIIT intervention | Experimental | Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short session HIIT | Behavioral | Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6-minute Walk at Baseline and Endpoint | 6-minute walk, total distance over 6 minutes in a 50 foot long hallway, participants asked to walk at a "brisk" pace. | baseline and at participant completion, an average of 3 months |
| Physical Activity Enjoyment at Baseline and Endpoint | Physical Activity Enjoyment Scale (PACES) that provides a valid instrument for assessing enjoyment in physical activity. There are 18 questions, each of which can receive a score from 1 to 7, where 7 is represents greater enjoyment. Scores presented as the mean across all questions giving an overall range of 1-7. | baseline and at participant completion, an average of 3 months |
| VO2max at Baseline and Endpoint | Performed as part of a symptom limited maximal endurance test on a cycle ergometer | baseline and at participant completion, an average of 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Short Physical Performance Battery at Baseline and Endpoint | Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons, including balance, side-by-side/semi-tandem/tandem stands, and gait speed. There are 3 subscales, each of which can receive from 0 to 4 points. Therefore the total range of the test spans summed scores from 0 to 12, where 12 is the best outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce R. Troen, MD | VA Western New York Healthcare System, Buffalo, NY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Western New York Healthcare System, Buffalo, NY | Buffalo | New York | 14215 | United States |
Thus, the investigators will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (a) a commitment to using the data only for research purposes and not to identify any individual participant; (b) a commitment to securing the data using appropriate computer technology; (c) restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource, and (d) a commitment to destroying or returning the data after analyses are completed. De identified data will be maintained on a VA server and will only be shared via encrypted devices. Co-Investigators will have access to the data collected as part of their aims. Investigators working on the grant will have access to the data through the PI. The data will be monitored routinely to maintain safety and productivity, as well as to assist with research dissemination annually.
Six months after publication.
Final data sets will be made available upon specific request and under an authorized Data Use Agreement. This, in addition to the publications being made available via PubMed Central, will enable validation of results by recipients.
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11 individuals were excluded due to the COVID pandemic.
Recruitment from 12/3/2018 - 12/31/2019. Recruitment occurred at the VA Western New York including through posted advertisements and word of mouth.
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| ID | Title | Description |
|---|---|---|
| FG000 | HIIT Intervention | Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle. Short session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HIIT Intervention | Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle. Short session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 6-minute Walk at Baseline and Endpoint | 6-minute walk, total distance over 6 minutes in a 50 foot long hallway, participants asked to walk at a "brisk" pace. | Posted | Mean | Standard Deviation | meters | baseline and at participant completion, an average of 3 months |
|
|
Adverse event data were collected weekly over a 14 week period for each participant, commencing from baseline assessments week 0, through the HIIT intervention (weeks 1 - 12 or up to 14), and ending with collection at end-point assessments.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HIIT Intervention | Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle. Short session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle. |
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Goal of trial was to evaluate recruitment, administration, and safety profile of short session HIIT, and not necessarily the efficacy of the HIIT protocol for functional capacity.
Trial does not have a non-exercise control group Trial features limited number of participants (23), which includes only 1 female Trial was stopped short due to COVID-19 pandemic, 8 of the 23 participants did not complete the total 12 weeks of training although all participants had at least 6 weeks of training.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bruce Troen | VA Kansas City Healthcare System | 913-574-4896 | bruce.troen@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 25, 2022 | Feb 26, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 17, 2021 | Mar 27, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| D055948 | Sarcopenia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
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The goals of this proposal are to: 1) investigate the feasibility of recruiting and administering short session HIIT to frail, pre-frail, and non-frail older Veterans and 2) to characterize the physical performance benefits and serum microRNA (miRNA) profiles in those participants.
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| baseline and at participant completion, an average of 3 months |
| Frailty at Baseline and Endpoint | Fried frailty phenotype assessment includes: gait speed, grip strength, endurance, activity level, weight loss. These assessments report summed scores of 0 to 5, where 0 is the best outcome. If gait speed or grip strength (m/sec or kg) falls within the lowest quintile (20%) for the age and gender adjusted range, then it is given a score of "1". If both questions on the endurance or activity measures are positive then then it is given a score of "1". If weight loss is greater than 5% over the past year, then it is given a score of "1". | baseline and at participant completion, an average of 3 months |
| Quality of Life Survey at Baseline and Endpoint | Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF). There are 14 subscales with scores of 1 to 5, where 5 is the better outcome. Therefore the total range of the test spans scores from 14 to 70, where 70 is the best outcome. The final score as a percentage with range being 0-100% and top being 100%. This percentage is calculated as: 100 * ((participant's score - 14) / 56). | baseline and at participant completion, an average of 3 months |
| Cognitive Survey at Baseline and Endpoint | VA-SLUMS: VA Saint Louis University Mental Status screen. Survey includes 11 questions allowing a range of scores from 1-30 points, where higher scores represent greater mental outcomes. | baseline and at participant completion, an average of 3 months |
| Activities of Daily Living & Instrumental Activities of Daily Living Survey at Baseline and Endpoint | The Activities of Daily living and instrumental activities of daily living are a survey comprised of 14 questions including ability to: dress, eat, ambulate, toilet, hygiene, shop, housework, accounting, food preparation, and use transportation/telephone. Each question gives up to 1 point with a total range of 0-14. Higher scores indicate less independence and greater reliance on support. | baseline and at participant completion, an average of 3 months |
| microRNA Profiling at Baseline and Endpoint | Next Generation Sequencing of microRNA species from serum. | baseline and at participant completion, an average of 3 months |
| Serum 25-hydroxy-vitamin D at Baseline | serum 25-hydroxy-vitamin D was measured from serum isolated from blood collected at baseline and measured using ELISA | baseline |
| C-reactive Protein Level at Baseline and Endpoint | C-reactive protein was measured from isolated serum samples at baseline and endpoint using ELISA | baseline and at participant completion, an average of 3 months |
| Quadriceps Strength at Baseline and Endpoint | Maximal quadriceps strength. This will be measured with the MicroFET2 dynamometer with a readout in kilograms (kg) of force. | baseline and at participant completion, an average of 3 months |
| FRAIL Scale Survey at Baseline and Endpoint | FRAIL scale: fatigability, resistance, ambulation, illnesses, loss of weight. If the answers to any of the questions is yes, then given score is "1" with a total survey range of 0 to 5. Higher scores represent greater frailty. | baseline and at participant completion, an average of 3 months |
| Serum Interleukin-6 Level at Baseline and Endpoint | Interleukin-6 collected from serum extracted from blood samples taken at baseline and endpoint and measured using ELISA | baseline and at participant completion, an average of 3 months |
| Serum Interleukin-10 Level at Baseline and Endpoint | Interleukin-10 collected from serum extracted from blood samples taken at baseline and endpoint and measured using ELISA | baseline and at participant completion, an average of 3 months |
| Number of Participants With Muscle Tissue Oxygenation Raw Data Collected | Seeking to collect raw data using functional near infra-red spectroscopy to analyze quadriceps during VO2max test. This work is the first steps in the development of techniques that analyze muscle blood flow and tissue oxygenation during exercise. | baseline and at participant completion, an average of 3 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Smoking status | Count of Participants | Participants |
|
|
|
|
| Primary | Physical Activity Enjoyment at Baseline and Endpoint | Physical Activity Enjoyment Scale (PACES) that provides a valid instrument for assessing enjoyment in physical activity. There are 18 questions, each of which can receive a score from 1 to 7, where 7 is represents greater enjoyment. Scores presented as the mean across all questions giving an overall range of 1-7. | One participant was not able to complete the assessment due to scheduling conflict. | Posted | Mean | Standard Deviation | Scores on a scale | baseline and at participant completion, an average of 3 months |
|
|
|
|
| Primary | VO2max at Baseline and Endpoint | Performed as part of a symptom limited maximal endurance test on a cycle ergometer | 8 participants were not able to complete the VO2max end point assessment due to COVID pandemic study cessation. One participant was not able to complete the assessment due to scheduling conflict. | Posted | Mean | Standard Deviation | mL/min/kg | baseline and at participant completion, an average of 3 months |
|
|
|
|
| Secondary | Short Physical Performance Battery at Baseline and Endpoint | Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons, including balance, side-by-side/semi-tandem/tandem stands, and gait speed. There are 3 subscales, each of which can receive from 0 to 4 points. Therefore the total range of the test spans summed scores from 0 to 12, where 12 is the best outcome. | Posted | Mean | Standard Deviation | score on a scale | baseline and at participant completion, an average of 3 months |
|
|
|
|
| Secondary | Frailty at Baseline and Endpoint | Fried frailty phenotype assessment includes: gait speed, grip strength, endurance, activity level, weight loss. These assessments report summed scores of 0 to 5, where 0 is the best outcome. If gait speed or grip strength (m/sec or kg) falls within the lowest quintile (20%) for the age and gender adjusted range, then it is given a score of "1". If both questions on the endurance or activity measures are positive then then it is given a score of "1". If weight loss is greater than 5% over the past year, then it is given a score of "1". | Posted | Mean | Standard Deviation | score on a scale | baseline and at participant completion, an average of 3 months |
|
|
|
|
| Secondary | Quality of Life Survey at Baseline and Endpoint | Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF). There are 14 subscales with scores of 1 to 5, where 5 is the better outcome. Therefore the total range of the test spans scores from 14 to 70, where 70 is the best outcome. The final score as a percentage with range being 0-100% and top being 100%. This percentage is calculated as: 100 * ((participant's score - 14) / 56). | Posted | Mean | Standard Deviation | % of Max Score | baseline and at participant completion, an average of 3 months |
|
|
|
|
| Secondary | Cognitive Survey at Baseline and Endpoint | VA-SLUMS: VA Saint Louis University Mental Status screen. Survey includes 11 questions allowing a range of scores from 1-30 points, where higher scores represent greater mental outcomes. | One participant was not able to complete the assessment due to scheduling conflict. | Posted | Mean | Standard Deviation | score on a scale | baseline and at participant completion, an average of 3 months |
|
|
|
|
| Secondary | Activities of Daily Living & Instrumental Activities of Daily Living Survey at Baseline and Endpoint | The Activities of Daily living and instrumental activities of daily living are a survey comprised of 14 questions including ability to: dress, eat, ambulate, toilet, hygiene, shop, housework, accounting, food preparation, and use transportation/telephone. Each question gives up to 1 point with a total range of 0-14. Higher scores indicate less independence and greater reliance on support. | Posted | Mean | Standard Deviation | Score on a scale | baseline and at participant completion, an average of 3 months |
|
|
|
|
| Secondary | microRNA Profiling at Baseline and Endpoint | Next Generation Sequencing of microRNA species from serum. | RNA was isolated from participant serum samples and sequenced. However, none of the sequenced RNA were microRNA sequences, therefore analysis could not be performed. Consequently, there was no microRNA data that could be presented in a table. | Posted | baseline and at participant completion, an average of 3 months |
|
|
| Secondary | Serum 25-hydroxy-vitamin D at Baseline | serum 25-hydroxy-vitamin D was measured from serum isolated from blood collected at baseline and measured using ELISA | No Statistical Analysis was performed as this was only a baseline measurement. | Posted | Mean | Standard Deviation | ng/ml | baseline |
|
|
|
| Secondary | C-reactive Protein Level at Baseline and Endpoint | C-reactive protein was measured from isolated serum samples at baseline and endpoint using ELISA | Posted | Mean | Standard Deviation | ug/uL | baseline and at participant completion, an average of 3 months |
|
|
|
|
| Secondary | Quadriceps Strength at Baseline and Endpoint | Maximal quadriceps strength. This will be measured with the MicroFET2 dynamometer with a readout in kilograms (kg) of force. | One participant was not able to complete the assessment due to scheduling conflict. | Posted | Mean | Standard Deviation | kg | baseline and at participant completion, an average of 3 months |
|
|
|
|
| Secondary | FRAIL Scale Survey at Baseline and Endpoint | FRAIL scale: fatigability, resistance, ambulation, illnesses, loss of weight. If the answers to any of the questions is yes, then given score is "1" with a total survey range of 0 to 5. Higher scores represent greater frailty. | Posted | Mean | Standard Deviation | Score on a scale | baseline and at participant completion, an average of 3 months |
|
|
|
|
| Secondary | Serum Interleukin-6 Level at Baseline and Endpoint | Interleukin-6 collected from serum extracted from blood samples taken at baseline and endpoint and measured using ELISA | Posted | Mean | Standard Deviation | pg/mL | baseline and at participant completion, an average of 3 months |
|
|
|
|
| Secondary | Serum Interleukin-10 Level at Baseline and Endpoint | Interleukin-10 collected from serum extracted from blood samples taken at baseline and endpoint and measured using ELISA | Posted | Mean | Standard Deviation | pg/mL | baseline and at participant completion, an average of 3 months |
|
|
|
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| Secondary | Number of Participants With Muscle Tissue Oxygenation Raw Data Collected | Seeking to collect raw data using functional near infra-red spectroscopy to analyze quadriceps during VO2max test. This work is the first steps in the development of techniques that analyze muscle blood flow and tissue oxygenation during exercise. | The goal of this project was to determine if raw functional near infrared spectroscopy data could be collected in participants. Data collection was verified. This work lays the foundation for future efforts in new experiments to determine methods to analyze the raw data to generate understandable data for interpretation - and lead to better understanding of the impacts of exercise on blood flow in muscle tissue. | Posted | Count of Participants | Participants | baseline and at participant completion, an average of 3 months |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
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| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D012816 | Signs and Symptoms |
| D001519 | Behavior |
| Title | Measurements |
|---|---|
|
| Left Leg - Endpoint |
|