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| Name | Class |
|---|---|
| University of Washington | OTHER |
| University of Colorado, Denver | OTHER |
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The purpose of this randomized clinical trial is to characterize the effects of two exercise interventions, high-intensity interval training (HIIT) and continuous moderate-intensity exercise (CME), on sleep and inflammation in older people living with HIV (PWH). This study is a sub-study associated with The High Intensity Exercise Study to Attenuate Limitations and Train Habits in Older Adults with HIV (HEALTH-HIV; NCT04550676). The investigators propose the following aims: Aim 1. Compare the effectiveness of HIIT and CME exercise interventions on sleep in older PWH. Aim 2. Quantify inflammation markers associated with sleep quality (self-report surveys) in older PWH at baseline, between (week 8) and after exercise interventions (HIIT and CME) (week 16). The investigators hypothesize HIIT will lead to greater improvement in sleep quality (duration and quality) compared to CME and older PWH who experience poor sleep quality and the CME intervention will have increased inflammation markers compared to older PWH who experience better sleep quality and the HIIT intervention. The intervention is being delivered by research personnel at the University of Washington associated with the HEALTH-HIV study (NCT04550676). Data for this study will only be collected at the University of Washington site of the HEALTH-HIV study.
An estimated 50% of people living with HIV (PWH) in the United States are 50 years and older. Although HIV antiretroviral therapy is effective, older PWH are diagnosed with comorbidities at an earlier age, which contributes to poorer health outcomes, including poor sleep quality. Sleep quality is a modifiable behavior in PWH. Higher levels of specific systemic inflammation markers are associated with poor sleep quality in the general population as well as PWH. Less physical activity is also associated with increased inflammation. The collective or interacting impact of low levels of physical activity and inflammation on poor sleep quality may be stronger than either independent factor; therefore, it is vital to examine the potentially causal pathway between physical activity, sleep, and inflammation in order to help mitigate poor sleep quality. HIIT is safe and has higher efficacy in improving health outcomes compared to CME in those with chronic illness (i.e., coronary artery disease, diabetes), yet little is known about the effects of HIIT on sleep in people living with HIV. The primary outcome measures include: change in sleep quality and patterns of sleep from week 0 to 16 of the intervention and change in inflammation markers from week 0 to 8 and week 0 to 16 of the intervention. Our primary sleep quality outcomes will be the sleep fragmentation index, sleep efficiency, and mean sleep duration for sleep quantity. All three will be based on actigraphy. The primary inflammation markers of interest are interleukin (IL)-6, IL-10, IL-13, IFN-y, C reactive protein (CRP) and tumor necrosis factor (TNF)-α due to prior association with sleep quality, other inflammation markers, IL-1β, IL-2, IL-4, IL-8 and IL-12p70 will be exploratory to identify potential pathways of sleep impairments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High intensity interval training | Experimental | The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight. |
|
| Continuous moderate intensity exercise | Active Comparator | The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIIT | Behavioral | The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Quality | Change in sleep quality will be assessed through the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a validated, self-report instrument assessing sleep quality. Possible scores range from 0-21, with higher scores indicating poorer sleep quality. | 0-16 weeks |
| Sleep Fragmentation Index | Change in sleep fragmentation index will be assessed through wrist actigraphy. Sleep Fragmentation Index is an actigraphy-derived metric generated by the Philips Respironics Actiwatch Spectrum Plus device. It quantifies sleep disruption by combining movement events and brief arousals detected throughout the sleep period. Higher values indicate greater sleep fragmentation (poorer sleep continuity), whereas lower values indicate more consolidated sleep (better sleep continuity). The index is calculated using the Actiwatch Spectrum Plus proprietary algorithm, which incorporates the frequency and intensity of movement epochs and wake episodes. | 0-16 weeks |
| Sleep Efficiency | Change in sleep efficiency will be assessed through wrist actigraphy. Sleep efficiency reflects the percentage of time spent asleep while in bed and is derived from actigraphy-based sleep/wake scoring. | 0-16 weeks |
| Mean Sleep Duration | Change in mean sleep duration will be assessed through wrist actigraphy. Mean sleep duration reflects the average number of minutes spent asleep per night and is derived from actigraphy based sleep/wake scoring. | 0-16 weeks |
| Interleukin Inflammation Markers IL-6 | Change in inflammation markers. Specifically examining interleukin (IL)-6. | 0-16 weeks |
| Interleukin Inflammation Markers IL-8 |
| Measure | Description | Time Frame |
|---|---|---|
| Interferon Gamma Inflammation Marker | Change in inflammation markers. Specifically examining interferon gamma (IFN-y). | 0-16 weeks |
| C-reactive Protein Inflammation Marker | Change in inflammation markers. Specifically examining C-reactive protein (CRP). |
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Inclusion Criteria:
Exclusion Criteria:
Any gender can be included.
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| Name | Affiliation | Role |
|---|---|---|
| Christine Horvat Davey, PhD, RN | Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Aurora | Colorado | 80045 | United States | ||
| Case Western Reserve University |
A de-identified data set may be shared with investigators upon written request, review and approval by institutional officials, and establishing a data use agreement. Investigators requesting other study documents (protocol, analysis plan, informed consent, code, etc.) should contact the study team.
The investigator will make the following available upon request after the primary manuscript is published: the trial description information, protocol, statistical analysis plan (SAP), informed consent form (ICF). Data will be posted to ClinicalTrials.gov after publication of the primary manuscript. Until that time, a message will also appear stating that the trial data will be available after publication of the primary manuscript.
Investigators interested in acquiring study data should contact the study team. Sharing of de-identified data will be considered upon review/approval of the request by the Institutional Review Board, with a data use agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | High Intensity Interval Training | High intensity interval training (HIIT): The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight. |
| FG001 | Continuous Moderate Intensity Exercise | Continuous moderate intensity exercise (CME): The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Intensity Interval Training | HIIT: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Sleep Quality | Change in sleep quality will be assessed through the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a validated, self-report instrument assessing sleep quality. Possible scores range from 0-21, with higher scores indicating poorer sleep quality. | Posted | Mean | Standard Deviation | score on a scale | 0-16 weeks |
|
Baseline to Week 16.
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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 | High Intensity Interval Training | HIIT: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| infection related (including COVID) | Infections and infestations | Systematic Assessment | Hospitalization for pneumonia (COVID negative) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Joint, Tendon or Muscle Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
Pilot study with a small sample size and missing data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine Horvat Davey | Case Western Reserve University | 440-368-5352 | Christine.horvatdavey@case.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 14, 2024 | Apr 24, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 10, 2024 | Apr 24, 2026 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 23, 2025 | May 20, 2026 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Participants will first be randomized to continuous moderate intensity or high-intensity interval training for 16 weeks.
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| CME | Behavioral | The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight. |
|
Change in inflammation markers. Specifically examining interleukin (IL)-8. |
| 0-16 weeks |
| Interleukin Inflammation Markers IL-10 | Change in inflammation markers. Specifically examining interleukin (IL)-10. | 0-16 weeks |
| Interleukin Inflammation Markers IL-13 | Change in inflammation markers. Specifically examining interleukin (IL)-13. | 0-16 weeks |
| Interleukin Inflammation Markers IL-1β | Change in inflammation markers. Specifically examining interleukin (IL)-1β. | 0-16 weeks |
| Interleukin Inflammation Markers IL-2 | Change in inflammation markers. Specifically examining interleukin (IL)-2. | 0-16 weeks |
| Interleukin Inflammation Markers IL-4 | Change in inflammation markers. Specifically examining interleukin (IL)-4. | 0-16 weeks |
| Interleukin Inflammation Markers IL-12p70 | Change in inflammation markers. Specifically examining interleukin (IL)-12p70. | 0-16 weeks |
| 0-16 weeks |
| Tumor Necrosis Factor Alpha Inflammation Marker | Change in inflammation markers. Specifically examining tumor necrosis factor alpha (TNF-α). | 0-16 weeks |
| Cleveland |
| Ohio |
| 44106 |
| United States |
| University if Washington | Seattle | Washington | 98195 | United States |
| BG001 | Continuous Moderate Intensity Exercise | CME: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Sleep Quality | The Pittsburgh Sleep Quality Index (PSQI) is a self-reported questionnaire that assesses sleep quality over a 1-month time interval. It consists of 19 individual items, creating 7 component scores that are summed to yield one global score. The global score ranges from 0 to 21. Higher scores represent worse sleep quality (a global score of greater than 5 indicates poor sleep quality). | Mean | Standard Deviation | Score on a scale |
|
| Sleep Fragmentation Index | Sleep Fragmentation Index is an actigraphy-derived metric generated by the Philips Respironics Actiwatch Spectrum Plus device. It quantifies sleep disruption by combining movement events and brief arousals detected throughout the sleep period. Higher values indicate greater sleep fragmentation (poorer sleep continuity), whereas lower values indicate more consolidated sleep (better sleep continuity). The index is calculated using the Actiwatch Spectrum Plus proprietary algorithm, which incorporates the frequency and intensity of movement epochs and wake episodes. | Only 46 participants had valid actigraphy data. | Mean | Standard Deviation | index |
|
| Sleep Efficiency | Only 46 participants had valid actigraphy data. | Mean | Standard Deviation | percentage of time asleep |
|
| Mean Sleep Duration | Only 46 participants had valid actigraphy data. | Mean | Standard Deviation | minutes per night |
|
| Interleukin Inflammation Markers IL-6 | Only 44 participants had valid inflammatory marker data. | Mean | Standard Deviation | pg/mL |
|
| Interleukin Inflammation Markers IL-8 | Only 44 participants had valid inflammatory marker data. | Mean | Standard Deviation | pg/mL |
|
| Interleukin Inflammation Markers IL-10 | Only 44 participants had valid inflammatory marker data. | Mean | Standard Deviation | pg/mL |
|
| Interleukin Inflammation Markers IL-13 | Only 44 participants had valid inflammatory marker data. | Mean | Standard Deviation | pg/mL |
|
| Interleukin Inflammation Markers IL-1β | Only 44 participants had valid inflammatory marker data. | Mean | Standard Deviation | pg/mL |
|
| Interleukin Inflammation Markers IL-2 | Only 44 participants had valid inflammatory marker data. | Mean | Standard Deviation | pg/mL |
|
| Interleukin Inflammation Markers IL-4 | Only 44 participants had valid inflammatory marker data. | Mean | Standard Deviation | pg/mL |
|
| Interleukin Inflammation Markers IL-12p70 | Only 44 participants had valid inflammatory marker data. | Mean | Standard Deviation | pg/mL |
|
| Interferon Gamma Inflammation Marker | Only 44 participants had valid inflammatory marker data. | Mean | Standard Deviation | pg/mL |
|
| C-reactive Protein Inflammation Marker | Only 44 participants had valid inflammatory marker data. | Mean | Standard Deviation | ng/mL |
|
| Tumor Necrosis Factor Alpha Inflammation Marker | Only 44 participants had valid inflammatory marker data. | Mean | Standard Deviation | pg/mL |
|
CME: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight. |
|
|
|
| Primary | Sleep Fragmentation Index | Change in sleep fragmentation index will be assessed through wrist actigraphy. Sleep Fragmentation Index is an actigraphy-derived metric generated by the Philips Respironics Actiwatch Spectrum Plus device. It quantifies sleep disruption by combining movement events and brief arousals detected throughout the sleep period. Higher values indicate greater sleep fragmentation (poorer sleep continuity), whereas lower values indicate more consolidated sleep (better sleep continuity). The index is calculated using the Actiwatch Spectrum Plus proprietary algorithm, which incorporates the frequency and intensity of movement epochs and wake episodes. | Participants with valid actigraphy derived sleep fragmentation index data at both baseline and Week 16. | Posted | Mean | Standard Deviation | index | 0-16 weeks |
|
|
|
|
| Primary | Sleep Efficiency | Change in sleep efficiency will be assessed through wrist actigraphy. Sleep efficiency reflects the percentage of time spent asleep while in bed and is derived from actigraphy-based sleep/wake scoring. | Participants with valid actigraphy-derived sleep efficiency data at both baseline and Week 16. | Posted | Mean | Standard Deviation | percentage of time asleep | 0-16 weeks |
|
|
|
|
| Primary | Mean Sleep Duration | Change in mean sleep duration will be assessed through wrist actigraphy. Mean sleep duration reflects the average number of minutes spent asleep per night and is derived from actigraphy based sleep/wake scoring. | Participants with valid actigraphy derived sleep duration data at both baseline and Week 16. | Posted | Mean | Standard Deviation | minutes per night | 0-16 weeks |
|
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|
|
| Primary | Interleukin Inflammation Markers IL-6 | Change in inflammation markers. Specifically examining interleukin (IL)-6. | Participants with valid interleukin (IL)-6 measurements at baseline and Week 16. | Posted | Mean | Standard Deviation | pg/mL | 0-16 weeks |
|
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|
|
| Secondary | Interferon Gamma Inflammation Marker | Change in inflammation markers. Specifically examining interferon gamma (IFN-y). | Participants with valid interferon-gamma (IFN-y) measurements at baseline and Week 16. | Posted | Mean | Standard Error | pg/ml | 0-16 weeks |
|
|
|
|
| Secondary | C-reactive Protein Inflammation Marker | Change in inflammation markers. Specifically examining C-reactive protein (CRP). | Participants with valid CRP measurements at baseline and Week 16. | Posted | Mean | Standard Deviation | ng/mL | 0-16 weeks |
|
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|
|
| Secondary | Tumor Necrosis Factor Alpha Inflammation Marker | Change in inflammation markers. Specifically examining tumor necrosis factor alpha (TNF-α). | Participants with valid TNF-α measurements at baseline and Week 16. | Posted | Mean | Standard Deviation | pg/mL | 0-16 weeks |
|
|
|
|
| Primary | Interleukin Inflammation Markers IL-8 | Change in inflammation markers. Specifically examining interleukin (IL)-8. | Participants with valid interleukin (IL)-8 measurements at baseline and Week 16. | Posted | Mean | Standard Deviation | pg/mL | 0-16 weeks |
|
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|
|
| Primary | Interleukin Inflammation Markers IL-10 | Change in inflammation markers. Specifically examining interleukin (IL)-10. | Participants with valid interleukin (IL)-10 measurements at baseline and Week 16. | Posted | Mean | Standard Deviation | pg/mL | 0-16 weeks |
|
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|
|
| Primary | Interleukin Inflammation Markers IL-13 | Change in inflammation markers. Specifically examining interleukin (IL)-13. | Participants with valid interleukin (IL)-13 measurements at baseline and Week 16. | Posted | Mean | Standard Deviation | pg/mL | 0-16 weeks |
|
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| Primary | Interleukin Inflammation Markers IL-1β | Change in inflammation markers. Specifically examining interleukin (IL)-1β. | Participants with valid interleukin (IL)-1β measurements at baseline and Week 16. | Posted | Mean | Standard Deviation | pg/mL | 0-16 weeks |
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| Primary | Interleukin Inflammation Markers IL-2 | Change in inflammation markers. Specifically examining interleukin (IL)-2. | Participants with valid interleukin (IL)-2 measurements at baseline and Week 16. | Posted | Mean | Standard Deviation | pg/mL | 0-16 weeks |
|
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| Primary | Interleukin Inflammation Markers IL-4 | Change in inflammation markers. Specifically examining interleukin (IL)-4. | Participants with valid interleukin (IL)-4 measurements at baseline and Week 16. | Posted | Mean | Standard Deviation | pg/mL | 0-16 weeks |
|
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| Primary | Interleukin Inflammation Markers IL-12p70 | Change in inflammation markers. Specifically examining interleukin (IL)-12p70. | Participants with valid interleukin (IL)-12p70 measurements at baseline and Week 16. | Posted | Mean | Standard Deviation | pg/mL | 0-16 weeks |
|
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|
|
| 0 |
| 25 |
| 2 |
| 25 |
| 14 |
| 25 |
| EG001 | Continuous Moderate Intensity Exercise | CME: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight. | 0 | 27 | 1 | 27 | 17 | 27 |
|
| infection related (including COVID); neurologic | Infections and infestations | Systematic Assessment | Possible seizure secondary to pneumonia at home let to five day hospitalization. |
|
| other | Nervous system disorders | Systematic Assessment | Syncope during leg press |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Respiratory infection | Infections and infestations | Systematic Assessment |
|
| Diarrhea, nausea or vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| COVID infection | Infections and infestations | Systematic Assessment |
|
Not provided
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Unknown or Not Reported |
|