Meal Delivery and Exercise
- Conditions
- Frailty
- Interventions
- Behavioral: Meals onlyBehavioral: Meals plus exercise
- Registration Number
- NCT04906759
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- homebound (normally unable to leave the home unassisted)
- frail or prefrail by The Fried Frailty Phenotype (FFP)
- medically stable
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Meals only Meals only - Meals plus exercise Meals plus exercise -
- Primary Outcome Measures
Name Time Method Change in total FFP score as assessed by the Fried Frailty Phenotype (FFP) screening test 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 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 4 weeks,8 weeks,12 weeks from baseline Change in measure of HSP70 (ng/mL) expression 4 weeks,8 weeks,12 weeks from baseline Change in Measure of sIL-6R (pg/mL) expression 4 weeks,8 weeks,12 weeks from baseline
- Secondary Outcome Measures
Name Time Method 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 This consists of 6 questions and each is scored form 0(patient is very dependent)-6(patient is independent)
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 The FFP defines frailty as having 3 or more characteristics of unintentional weight loss, fatigue, decreased physical activity, weakness, and slowness.Those who have 1 or 2 characteristics are considered pre frail, while those who have no characteristics are robust.
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 This consists of 8 questions and each has a summary score range from 0 (low function, dependent) to 8 (high function, independent) for women and 0 through 5 for men to avoid potential gender bias.
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 Grip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles .This is measured by using a dynamometer which will be squeezed by the participant 3 times in each hand.The force is measured in kilograms.
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 LSNS-R total score is an equally weighted sum of twelve items. Scores range from 0 to 90, a higher number indicating a better outcome
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 This questionnaire consists of 20 questions and each is answered from 1(never)-4(always) for a total score ranging form 20-80
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
Trial Locations
- Locations (1)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States