Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04906759

Meal Delivery and Exercise

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Frailty Behavior Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Meals plus exercise

Behavioral

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.

Meals only

Behavioral

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 outcomes

  1. 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

  2. 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)

  3. Change in measure of HSP70 (ng/mL) expression

    Time frame: 4 weeks,8 weeks,12 weeks from baseline

  4. Change in Measure of MIP-1β (pg/mL) expression

    Time frame: 4 weeks,8 weeks,12 weeks from baseline

  5. Change in Measure of sIL-6R (pg/mL) expression

    Time frame: 4 weeks,8 weeks,12 weeks from baseline

Secondary outcomes

  1. Change in overall frailty status as assessed by the Fried Frailty Phenotype (FFP) screening test

    Time frame: 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.

  2. Change in grip strength

    Time frame: 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.

  3. Change in daily average steps from the activity tracker

    Time frame: 4 weeks,8 weeks,12 weeks from baseline

  4. Number of patients that required emergency room visits

    Time frame: 6 months post baseline visit

  5. Number of patients that required hospitalization

    Time frame: 6 months post baseline visit

  6. Change in activities of daily living as measured by the Katz Index of Independence in Activities of Daily Living

    Time frame: 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)

  7. Change in instrumental activities of daily living as measured by the LAWTON - BRODY INSTRUMENTAL ACTIVITIES OF DAILY LIVING SCALE (I.A.D.L.)

    Time frame: 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.

  8. Change in loneliness as assessed by the UCLA Loneliness Scale (ULS)

    Time frame: 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

  9. Social network as assessed by the LUBBEN SOCIAL NETWORK SCALE - 18 (LSNS-18)

    Time frame: 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

  10. change in measure of IL-6 (pg/mL) expression

    Time frame: 4 weeks,8 weeks,12 weeks from baseline

  11. Change in measures of CRP (ng/mL) expression

    Time frame: 4 weeks,8 weeks,12 weeks from baseline

  12. Change in measures of TNF-α (pg/mL) expression

    Time frame: 4 weeks,8 weeks,12 weeks from baseline

  13. Change in measures of microbiome (fecal sample) expression

    Time frame: 4 weeks,8 weeks,12 weeks from baseline

  14. change in IL-6 (pg/mL) as measured by the frailty status

    Time frame: 4 weeks,8 weeks,12 weeks from baseline

  15. change in CRP (ng/mL) as measured by the frailty status

    Time frame: 4 weeks,8 weeks,12 weeks from baseline

  16. change in TNF-α (pg/mL) as measured by the frailty status

    Time frame: 4 weeks,8 weeks,12 weeks from baseline

  17. change in HSP70 (ng/mL) as measured by the frailty status

    Time frame: 4 weeks,8 weeks,12 weeks from baseline

  18. change in MIP-1β (pg/mL) as measured by the frailty status

    Time frame: 4 weeks,8 weeks,12 weeks from baseline

  19. change in sIL-6R (pg/mL) as measured by the frailty status

    Time frame: 4 weeks,8 weeks,12 weeks from baseline

  20. change in microbiome (fecal sample) as measured by the frailty status

    Time frame: 4 weeks,8 weeks,12 weeks from baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Lee, MD,MS

CONTACT

[email protected]

713-500-5457

Paola Robles Cordova

CONTACT

[email protected]

(713) 500-7904

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

A Meal Delivery and Exercise Intervention to Increase Resilience in Homebound Older Adults

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
May 28, 2021
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.