Clinical trial NCT04906759: Meal Delivery and Exercise
Official title: A Meal Delivery and Exercise Intervention to Increase Resilience in Homebound Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Frailty
Keywords: homebound patients
exercise
nutrition
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-05-28
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in gait speed
timeFrame: 4 weeks,8 weeks,12 weeks from baseline
measure: Change in total FFP score as assessed by the Fried Frailty Phenotype (FFP) screening test
timeFrame: 4 weeks,8 weeks,12 weeks from baseline
measure: Change in measure of HSP70 (ng/mL) expression
timeFrame: 4 weeks,8 weeks,12 weeks from baseline
measure: Change in Measure of MIP-1β (pg/mL) expression
timeFrame: 4 weeks,8 weeks,12 weeks from baseline
measure: Change in Measure of sIL-6R (pg/mL) expression
timeFrame: 4 weeks,8 weeks,12 weeks from baseline
Secondary outcomes:
measure: Change in overall frailty status as assessed by the Fried Frailty Phenotype (FFP) screening test
timeFrame: 4 weeks,8 weeks,12 weeks from baseline
measure: Change in grip strength
timeFrame: 4 weeks,8 weeks,12 weeks from baseline
measure: Change in daily average steps from the activity tracker
timeFrame: 4 weeks,8 weeks,12 weeks from baseline
measure: Number of patients that required emergency room visits
timeFrame: 6 months post baseline visit
measure: Number of patients that required hospitalization
timeFrame: 6 months post baseline visit
measure: Change in activities of daily living as measured by the Katz Index of Independence in Activities of Daily Living
timeFrame: 4 weeks,8 weeks,12 weeks from baseline
measure: Change in instrumental activities of daily living as measured by the LAWTON - BRODY INSTRUMENTAL ACTIVITIES OF DAILY LIVING SCALE (I.A.D.L.)
timeFrame: 4 weeks,8 weeks,12 weeks from baseline
measure: Change in loneliness as assessed by the UCLA Loneliness Scale (ULS)
timeFrame: 4 weeks,8 weeks,12 weeks from baseline
measure: Social network as assessed by the LUBBEN SOCIAL NETWORK SCALE - 18 (LSNS-18)
timeFrame: 4 weeks,8 weeks,12 weeks from baseline
measure: change in measure of IL-6 (pg/mL) expression
timeFrame: 4 weeks,8 weeks,12 weeks from baseline
measure: Change in measures of CRP (ng/mL) expression
timeFrame: 4 weeks,8 weeks,12 weeks from baseline
measure: Change in measures of TNF-α (pg/mL) expression
timeFrame: 4 weeks,8 weeks,12 weeks from baseline
measure: Change in measures of microbiome (fecal sample) expression
timeFrame: 4 weeks,8 weeks,12 weeks from baseline
measure: change in IL-6 (pg/mL) as measured by the frailty status
timeFrame: 4 weeks,8 weeks,12 weeks from baseline
measure: change in CRP (ng/mL) as measured by the frailty status
timeFrame: 4 weeks,8 weeks,12 weeks from baseline
measure: change in TNF-α (pg/mL) as measured by the frailty status
timeFrame: 4 weeks,8 weeks,12 weeks from baseline
measure: change in HSP70 (ng/mL) as measured by the frailty status
timeFrame: 4 weeks,8 weeks,12 weeks from baseline
measure: change in MIP-1β (pg/mL) as measured by the frailty status
timeFrame: 4 weeks,8 weeks,12 weeks from baseline
measure: change in sIL-6R (pg/mL) as measured by the frailty status
timeFrame: 4 weeks,8 weeks,12 weeks from baseline
measure: change in microbiome (fecal sample) as measured by the frailty status
timeFrame: 4 weeks,8 weeks,12 weeks from baseline
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Jessica Lee, MD,MS
role: PRINCIPAL_INVESTIGATOR
References: