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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
100
Participants will receive 12 weeks of a MOW delivery service that will include 2 meals per day during the weekdays with 4 shelf-stable meals at the end of the week. The MOW driver will visit the participants in-person to ask a series of 5 questions about change in health status, joint/muscle injuries, new pain, falls, and poor appetite twice a week. Participants will also will receive an exercise kit from the MOW driver with their first meal delivery which will contain 2 tennis balls, 2 1-pound hand weights, and one towel. Every week, the driver will give the participants a handout containing 3 exercises from the NIA Go4Life Workout-to-Go book that are designed to help with strength/endurance, balance, and flexibility20. The participants will be asked to do the 3 exercises every day, if possible, on their own. Every 4 weeks during the 12-week study period and at 6 months follow up patients will have blood drawn for frailty and inflammatory biomarkers.
Participants will receive 12 weeks of a MOW delivery service that will include 2 meals per day during the weekdays with 4 shelf-stable meals at the end of the week. The MOW driver will visit the participants in-person to ask a series of 5 questions about change in health status, joint/muscle injuries, new pain, falls, and poor appetite twice a week. they will be asked to continue their usual level of activity.Every 4 weeks during the 12-week study period and at 6 months follow up patients will have blood drawn for frailty and inflammatory biomarkers.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
RECRUITINGChange in gait speed
this is the time one takes to walk a specified distance on level surfaces over a short distance and is measured in meters/second
Time frame: 4 weeks,8 weeks,12 weeks from baseline
Change in total FFP score as assessed by the Fried Frailty Phenotype (FFP) screening test
Score from 0(not frail),1-2(pre frail) and 3-5(frail)
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 MIP-1β (pg/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
Change in overall frailty status as assessed by the Fried Frailty Phenotype (FFP) screening test
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.
Time frame: 4 weeks,8 weeks,12 weeks from baseline
Change in grip strength
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.
Time frame: 4 weeks,8 weeks,12 weeks from baseline
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Change in daily average steps from the activity tracker
Time frame: 4 weeks,8 weeks,12 weeks from baseline
Number of patients that required emergency room visits
Time frame: 6 months post baseline visit
Number of patients that required hospitalization
Time frame: 6 months post baseline visit
Change in activities of daily living as measured by the Katz Index of Independence in Activities of Daily Living
This consists of 6 questions and each is scored form 0(patient is very dependent)-6(patient is independent)
Time frame: 4 weeks,8 weeks,12 weeks from baseline
Change in instrumental activities of daily living as measured by the LAWTON - BRODY INSTRUMENTAL ACTIVITIES OF DAILY LIVING SCALE (I.A.D.L.)
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.
Time frame: 4 weeks,8 weeks,12 weeks from baseline
Change in loneliness as assessed by the UCLA Loneliness Scale (ULS)
This questionnaire consists of 20 questions and each is answered from 1(never)-4(always) for a total score ranging form 20-80
Time frame: 4 weeks,8 weeks,12 weeks from baseline
Social network as assessed by the LUBBEN SOCIAL NETWORK SCALE - 18 (LSNS-18)
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
Time frame: 4 weeks,8 weeks,12 weeks from baseline
change in measure of IL-6 (pg/mL) expression
Time frame: 4 weeks,8 weeks,12 weeks from baseline
Change in measures of CRP (ng/mL) expression
Time frame: 4 weeks,8 weeks,12 weeks from baseline
Change in measures of TNF-α (pg/mL) expression
Time frame: 4 weeks,8 weeks,12 weeks from baseline
Change in measures of microbiome (fecal sample) expression
Time frame: 4 weeks,8 weeks,12 weeks from baseline
change in IL-6 (pg/mL) as measured by the frailty status
Time frame: 4 weeks,8 weeks,12 weeks from baseline
change in CRP (ng/mL) as measured by the frailty status
Time frame: 4 weeks,8 weeks,12 weeks from baseline
change in TNF-α (pg/mL) as measured by the frailty status
Time frame: 4 weeks,8 weeks,12 weeks from baseline
change in HSP70 (ng/mL) as measured by the frailty status
Time frame: 4 weeks,8 weeks,12 weeks from baseline
change in MIP-1β (pg/mL) as measured by the frailty status
Time frame: 4 weeks,8 weeks,12 weeks from baseline
change in sIL-6R (pg/mL) as measured by the frailty status
Time frame: 4 weeks,8 weeks,12 weeks from baseline
change in microbiome (fecal sample) as measured by the frailty status
Time frame: 4 weeks,8 weeks,12 weeks from baseline