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| ID | Type | Description | Link |
|---|---|---|---|
| K23AI108357 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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This pilot study will examine the effect of a mobile health text messaging platform linked to a digital physical activity tracker on physical activity among persons living with HIV and frailty.
HIV is associated with frailty, an important aging-related phenotype associated with adverse clinical outcomes. The investigators propose that personalized health coaching using a digital activity tracker with mobile health text messaging can increase physical activity in this population. The total duration of the intervention will be 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Activity Counseling | Placebo Comparator | Group receives baseline physical activity counseling. Group does not receive personalized, health coaching via "smart" text messages. |
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| Digital Activity Tracker/Smart Text Messaging | Experimental | Group receives baseline physical activity counseling. Group receives personalized, health coaching via "smart" text messages informed by digital activity tracker. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Activity Tracker | Other | Group wears physical activity tracker and receives physical activity feedback information informed by the tracker |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean daily step count | Mean daily step count will be assessed using a digital physical activity tracker | Baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Frailty as assessed by the Fried-based physical frailty phenotype | Frailty evaluated based on the standard 5 point Fried-based frailty phenotype construct (slow gait, weakness, weight loss, exhaustion, low physical activity) | Baseline, 12 weeks |
| Change in Physical Fitness as assessed by 12 minute walk |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Damani Piggott, MD, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11253156 | Background | Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146. |
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| Smart Text Messaging | Other | Group receives personalized, health coaching via "smart" text messages |
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| Physical Activity Counseling | Other | Group receives baseline counseling on physical activity |
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Physical fitness of participants will be assessed by the ability to do a 12 minute walk |
| Baseline, 12 weeks |
| Change in Muscle strength as assessed by isokinetic resistance | Muscle strength evaluated using isokinetic resistance testing on a Biodex system measuring peak torque expressed as foot pounds (lbs) | Baseline, 12 weeks |
| Percent change in fat mass | Fat mass will be measured using the dual-energy x-ray absorptiometry (DXA) scan | Baseline, 12 weeks |
| Percent change in lean mass | Lean mass will be measured using the dual-energy x-ray absorptiometry (DXA) scan | Baseline, 12 weeks |
| Change in Physical performance as assessed by the physical performance battery | Physical performance evaluated with the short physical performance battery | Baseline, 12 weeks |
| Change in Quality of Life as assessed by the Medical Outcomes Study HIV Health Survey (MOS-HIV) | The Medical Outcomes Study HIV Health Survey (MOS-HIV) is a brief, comprehensive measure of health-related quality of life. The 35-item questionnaire includes 10 dimensions (pain, physical, role, health perceptions, social and cognitive functioning, energy, mental health, health distress and quality of life). Each dimension is scored on a 0-100 scale (a higher score indicates better health related quality of life). An overall score is obtained through a summation of z scores from each domain. | Baseline, 12 weeks |
| Change in Interleukin-6 (IL-6) concentration | Interleukin-6 concentration in pg/ml will be measured at baseline and be compared to the concentration at 12 weeks to assess any change | Baseline, 12 weeks |
| Change in soluble Tumor Necrosis Factor Receptor 1 (sTNFR1) | sTNFR1 concentration in ng/ml will be measured at baseline and be compared to the concentration at 12 weeks to assess any change | Baseline, 12 weeks |