Meal Delivery and Exercise
Primary Purpose
Frailty
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meals plus exercise
Meals only
Sponsored by
About this trial
This is an interventional supportive care trial for Frailty focused on measuring homebound patients, exercise, nutrition
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.
Sites / Locations
- The University of Texas Health Science Center at HoustonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Meals plus exercise
Meals only
Arm Description
Outcomes
Primary Outcome Measures
Change 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
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)
Change in measure of HSP70 (ng/mL) expression
Change in Measure of MIP-1β (pg/mL) expression
Change in Measure of sIL-6R (pg/mL) expression
Secondary Outcome Measures
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.
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.
Change in daily average steps from the activity tracker
Number of patients that required emergency room visits
Number of patients that required hospitalization
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)
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.
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
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
change in measure of IL-6 (pg/mL) expression
Change in measures of CRP (ng/mL) expression
Change in measures of TNF-α (pg/mL) expression
Change in measures of microbiome (fecal sample) expression
change in IL-6 (pg/mL) as measured by the frailty status
change in CRP (ng/mL) as measured by the frailty status
change in TNF-α (pg/mL) as measured by the frailty status
change in HSP70 (ng/mL) as measured by the frailty status
change in MIP-1β (pg/mL) as measured by the frailty status
change in sIL-6R (pg/mL) as measured by the frailty status
change in microbiome (fecal sample) as measured by the frailty status
Full Information
NCT ID
NCT04906759
First Posted
May 25, 2021
Last Updated
January 9, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT04906759
Brief Title
Meal Delivery and Exercise
Official Title
A Meal Delivery and Exercise Intervention to Increase Resilience in Homebound Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 19, 2021 (Actual)
Primary Completion Date
February 28, 2026 (Anticipated)
Study Completion Date
February 28, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty
Keywords
homebound patients, exercise, nutrition
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Meals plus exercise
Arm Type
Experimental
Arm Title
Meals only
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Meals plus exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Meals only
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in gait speed
Description
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
Title
Change in total FFP score as assessed by the Fried Frailty Phenotype (FFP) screening test
Description
Score from 0(not frail),1-2(pre frail) and 3-5(frail)
Time Frame
4 weeks,8 weeks,12 weeks from baseline
Title
Change in measure of HSP70 (ng/mL) expression
Time Frame
4 weeks,8 weeks,12 weeks from baseline
Title
Change in Measure of MIP-1β (pg/mL) expression
Time Frame
4 weeks,8 weeks,12 weeks from baseline
Title
Change in Measure of sIL-6R (pg/mL) expression
Time Frame
4 weeks,8 weeks,12 weeks from baseline
Secondary Outcome Measure Information:
Title
Change in overall frailty status as assessed by the Fried Frailty Phenotype (FFP) screening test
Description
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
Title
Change in grip strength
Description
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
Title
Change in daily average steps from the activity tracker
Time Frame
4 weeks,8 weeks,12 weeks from baseline
Title
Number of patients that required emergency room visits
Time Frame
6 months post baseline visit
Title
Number of patients that required hospitalization
Time Frame
6 months post baseline visit
Title
Change in activities of daily living as measured by the Katz Index of Independence in Activities of Daily Living
Description
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
Title
Change in instrumental activities of daily living as measured by the LAWTON - BRODY INSTRUMENTAL ACTIVITIES OF DAILY LIVING SCALE (I.A.D.L.)
Description
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
Title
Change in loneliness as assessed by the UCLA Loneliness Scale (ULS)
Description
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
Title
Social network as assessed by the LUBBEN SOCIAL NETWORK SCALE - 18 (LSNS-18)
Description
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
Title
change in measure of IL-6 (pg/mL) expression
Time Frame
4 weeks,8 weeks,12 weeks from baseline
Title
Change in measures of CRP (ng/mL) expression
Time Frame
4 weeks,8 weeks,12 weeks from baseline
Title
Change in measures of TNF-α (pg/mL) expression
Time Frame
4 weeks,8 weeks,12 weeks from baseline
Title
Change in measures of microbiome (fecal sample) expression
Time Frame
4 weeks,8 weeks,12 weeks from baseline
Title
change in IL-6 (pg/mL) as measured by the frailty status
Time Frame
4 weeks,8 weeks,12 weeks from baseline
Title
change in CRP (ng/mL) as measured by the frailty status
Time Frame
4 weeks,8 weeks,12 weeks from baseline
Title
change in TNF-α (pg/mL) as measured by the frailty status
Time Frame
4 weeks,8 weeks,12 weeks from baseline
Title
change in HSP70 (ng/mL) as measured by the frailty status
Time Frame
4 weeks,8 weeks,12 weeks from baseline
Title
change in MIP-1β (pg/mL) as measured by the frailty status
Time Frame
4 weeks,8 weeks,12 weeks from baseline
Title
change in sIL-6R (pg/mL) as measured by the frailty status
Time Frame
4 weeks,8 weeks,12 weeks from baseline
Title
change in microbiome (fecal sample) as measured by the frailty status
Time Frame
4 weeks,8 weeks,12 weeks from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Lee, MD,MS
Phone
713-500-5457
Email
Jessica.Lee@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Paola Robles Cordova
Phone
(713) 500-7904
Email
Paola.RoblesCordova@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Lee, MD,MS
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Lee, MD,MS
Phone
713-500-5457
Email
Jessica.Lee@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Paola Robles Cordova
Phone
(713) 500-7904
Email
Paola.RoblesCordova@uth.tmc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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