A Meal Delivery and Exercise Intervention to Increase Resilience in Homebound Older Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Change in total FFP score as assessed by the Fried Frailty Phenotype (FFP) screening test
Study Overview
Brief Summary
The purpose of this study is to evaluate the effects of a home-based exercise program administered through Meals on wheels (MOW) on gait speed and frailty status and to assess the association between novel serum biomarkers (70 kilodalton heat shock proteins (HSP70),Macrophage Inflammatory Proteins(MIP1b), soluble IL-6 receptor alpha-chain (sIL-6R)) and established but non-specific frailty biomarkers (Interleukin 6 (IL-6), C-reactive protein (CRP), Tumor necrosis factor (TNF-α)) in frail and prefrail homebound older adults before and after the exercise intervention.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •homebound (normally unable to leave the home unassisted)
- •frail or prefrail by The Fried Frailty Phenotype (FFP)
- •medically stable
Exclusion Criteria
- •robust by FFP
- •have Mini-Cog score <3 and/or are unable to follow instructions
- •have a pre-diagnosed terminal illness
- •unable to ambulate
- •unable to use their upper extremities, and/or are already participating in physician-prescribed physical therapy or occupational therapy.
Outcomes
Primary Outcomes
Change in total FFP score as assessed by the Fried Frailty Phenotype (FFP) screening test
Time Frame: 4 weeks,8 weeks,12 weeks from baseline
Score from 0(not frail),1-2(pre frail) and 3-5(frail)
Change in gait speed
Time Frame: 4 weeks,8 weeks,12 weeks from baseline
this is the time one takes to walk a specified distance on level surfaces over a short distance and is measured in meters/second
Change in Measure of MIP-1β (pg/mL) expression
Time Frame: 4 weeks,8 weeks,12 weeks from baseline
Change in measure of HSP70 (ng/mL) expression
Time Frame: 4 weeks,8 weeks,12 weeks from baseline
Change in Measure of sIL-6R (pg/mL) expression
Time Frame: 4 weeks,8 weeks,12 weeks from baseline
Secondary Outcomes
- Change in activities of daily living as measured by the Katz Index of Independence in Activities of Daily Living(4 weeks,8 weeks,12 weeks from baseline)
- Change in daily average steps from the activity tracker(4 weeks,8 weeks,12 weeks from baseline)
- Change in overall frailty status as assessed by the Fried Frailty Phenotype (FFP) screening test(4 weeks,8 weeks,12 weeks from baseline)
- Number of patients that required hospitalization(6 months post baseline visit)
- Change in instrumental activities of daily living as measured by the LAWTON - BRODY INSTRUMENTAL ACTIVITIES OF DAILY LIVING SCALE (I.A.D.L.)(4 weeks,8 weeks,12 weeks from baseline)
- change in CRP (ng/mL) as measured by the frailty status(4 weeks,8 weeks,12 weeks from baseline)
- Change in measures of CRP (ng/mL) expression(4 weeks,8 weeks,12 weeks from baseline)
- change in TNF-α (pg/mL) as measured by the frailty status(4 weeks,8 weeks,12 weeks from baseline)
- Change in grip strength(4 weeks,8 weeks,12 weeks from baseline)
- Number of patients that required emergency room visits(6 months post baseline visit)
- Social network as assessed by the LUBBEN SOCIAL NETWORK SCALE - 18 (LSNS-18)(4 weeks,8 weeks,12 weeks from baseline)
- change in measure of IL-6 (pg/mL) expression(4 weeks,8 weeks,12 weeks from baseline)
- change in IL-6 (pg/mL) as measured by the frailty status(4 weeks,8 weeks,12 weeks from baseline)
- change in MIP-1β (pg/mL) as measured by the frailty status(4 weeks,8 weeks,12 weeks from baseline)
- Change in loneliness as assessed by the UCLA Loneliness Scale (ULS)(4 weeks,8 weeks,12 weeks from baseline)
- Change in measures of TNF-α (pg/mL) expression(4 weeks,8 weeks,12 weeks from baseline)
- Change in measures of microbiome (fecal sample) expression(4 weeks,8 weeks,12 weeks from baseline)
- change in HSP70 (ng/mL) as measured by the frailty status(4 weeks,8 weeks,12 weeks from baseline)
- change in sIL-6R (pg/mL) as measured by the frailty status(4 weeks,8 weeks,12 weeks from baseline)
- change in microbiome (fecal sample) as measured by the frailty status(4 weeks,8 weeks,12 weeks from baseline)
Investigators
Jessica Lee
Associate Professor
The University of Texas Health Science Center, Houston