ट्रायल रडार AI | ||
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क्लिनिकल ट्रायल NCT07206368 (ENHANCE) के लिए गिरना, सार्कोपेनिया, मोटापा वर्तमान में अभी भर्ती शुरू नहीं है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
Health Promotion With Targeted Exercise Intervention for Decreasing Fall Risk and Inactivity in Aging Veterans With Obesity and Signs of Sarcopenia (ENHANCE)
This project departs from the traditional weight-loss approach for older Veterans with obesity by prioritizing functional health and fall risk reduction through targeted exercise and health education, specifically for those with sarcopenia. The intervention leverages a live, virtual group format to overcome mobility and access barriers, integrates wearable sensors for precise outcome measurement, and addresses both physical and behavioral aspects of fall prevention in a scalable, Veteran-centered design. The project addresses key knowledge gaps including: the lack of tailored fall prevention strategies for older Veterans with both obesity and sarcopenia; limited evidence on whether exercise interventions are superior to health education alone in this population; and uncertainties about the best ways to preserve muscle quality and reduce disability without compromising functional health through traditional weight-loss approaches. It also explores how virtual, group-based delivery can overcome access barriers for at-risk Veterans. The investigators will address these knowledge gaps through the following aims:
Aim 1: Compare the effects of a targeted exercise-based fall prevention intervention plus health promotion education program vs. health promotion education alone on clinical measures of fall risk and dysmobility. The investigators hypothesize Veterans participating in the combined exercise and health education program will show greater reductions in fall risk (primary outcome: Four Square Step Test (FSST)) compared to those receiving education alone.
Aim 2: Determine if combined exercise and health education and/or health promotion education alone result in physical activity changes indicative of greater ability to engage/engagement in community mobility. The investigators hypothesize Veterans participating in combined exercise and health education and those receiving health promotion education alone will show increased community mobility abilities evidenced by improved physical activity engagement (primary outcome: weekly minutes of moderate-vigorous physical activity), as measured through accelerometry. Those in combined exercise and health education are expected to have greater improvements compared to those in health promotion education alone.
Aim 3: Determine if combined exercise and health education and/or health promotion education alone result in changes to lower extremity muscle quality. The investigators hypothesize Veterans participating in combined exercise and health education will demonstrate improvements in functional muscle quality (primary outcome: knee extension strength) which are not expected to be observed for those in health promotion education alone.
This study will inform tailored strategies for fall prevention in aging Veterans with obesity and sarcopenia, supporting updated clinical practice guidelines that go beyond weight loss. It leverages innovative, scalable, Veteran-centered virtual interventions designed to optimize independence for Veterans at high risk for falls.
Health Promotion With Targeted Exercise Intervention for Decreasing Fall Risk and Inactivity in Aging Veterans With Obesity and Signs of Sarcopenia
- ENHANCE
- RRD8-002-24W
- 1IK2RD000462 (अन्य अनुदान/वित्त पोषण संख्या) (Veterans Affairs Rehabilitation RDT Service)
| प्रतिभागी समूह/हाथ | हस्तक्षेप/इलाज |
|---|---|
प्रयोगात्मकEX + EDU Participation in a live virtual fall-prevention exercise intervention plus a health promotion education program. | Fall Prevention Exercise Participants will attend a virtual exercise-based group fall prevention class that focuses on movement and obstacle negotiation 3 times per week for 3 months. Health Promotion Education Participants will attend a virtual group health promotion education class that focuses on reasons to maintain a healthy lifestyle and local resources to support them in this. The sessions will take place 1 time per week for 3 months. |
सक्रिय तुलना समूहEDU Participation in a live virtual health promotion education program alone. | Health Promotion Education Participants will attend a virtual group health promotion education class that focuses on reasons to maintain a healthy lifestyle and local resources to support them in this. The sessions will take place 1 time per week for 3 months. |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Balance | The four-square step test will be used as a measure of balance. The change in amount of time it takes to complete the four-square step test is compared pre and post intervention | 3 months |
Physical activity | Weekly minutes of moderate-vigorous physical activity will be used as a measure of physical activity. The change in amount of weekly minutes is compared pre to post intervention. | 3 months |
Knee extension strength | A measure of the maximal isometric muscle strength produced in knee extensor muscles will be assessed with a handheld dynamometer device. Pre and post intervention levels will be compared. | 3 months |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Mobility | The timed up and go will be used as a measure of mobility. The change in amount of time it takes to complete the timed up and go test is compared pre to post intervention. | 3 months |
- Veteran status
- 55 years or older
- VA primary care provider
- Enrolled in the VA Maryland Health Care System for health care
- Body mass index between and including 30 - 40 kg/m^2
- Showing signs of sarcopenia
- Poorly controlled hypertensin
- Home oxygen use
- Contraindications to exercise or resistance exercise
- Significant cognitive impairment
- Other medical condition precluding patient participation in this study per the medical judgement of the study team
Maryland