Strength on Wheels: A Meal Delivery and Exercise Intervention for Homebound Older Adults

Frailty Clinical Trial

Official title:

Strength on Wheels: A Meal Delivery and Exercise Intervention for Homebound Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04087343
• Other study ID #: HSC-MS-19-0191
• Secondary ID: KL2TR003168
• Status: Completed
• Phase: N/A
• Start date: September 18, 2019
• Est. completion date: January 10, 2020

Study information

• Verified date: January 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to implement a home-based exercise program, administered through Interfaith Ministries of Greater Houston Meals on Wheels (MOWGH), and evaluate its effects on frailty status and nutritional markers in homebound older adults.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: January 10, 2020
• Est. primary completion date: January 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• enrolled in UT-Health Harris Health House Call Program (HCP)
• Frail or pre frail by FFP
• medically stable

Exclusion Criteria:

• robust by FFP
• Mini-Cog score <3 and/or are unable to follow instructions
• pre-diagnosed terminal illness
• unable to ambulate,and/or are unable to use their upper extremities

Related Conditions & MeSH terms

• Frailty

Intervention

Behavioral:
• Meals plus exercise
Patients will receive 12 weeks of meals on wheels meal delivery consisting of 3 meals per day during the weekdays with 6 frozen meals to cover the weekends.They will also receive an exercise kit on the first visit by the meal delivery driver with 2 tennis balls,2 1-pound hand weights, and one towel.Every week,the driver will give them 3 exercises from the National Institute on Aging's Go4Life Workout-to-Go book,1 exercise from each of 3 categories:strength/endurance, balance, and flexibility. They will be asked to do the 3 exercises every day.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
• Meals only
Patients will receive 12 weeks of an enhanced meals on wheels (MOW) in-person meal delivery consisting of 3 meals per day (1 shelf-stable, 1 hot, and 1 frozen) during the weekdays (Monday through Friday) with 6 frozen meals at the end of the week to cover the weekends.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline
Primary	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.	12 weeks after study initiation
Secondary	Levels of Plasma Vitamin C		baseline
Secondary	Levels of Plasma Vitamin C		12 weeks from baseline
Secondary	Levels of Serum Folate		Baseline
Secondary	Levels of Serum Folate		12 weeks from baseline
Secondary	Levels of Vitamin B12		Baseline
Secondary	Levels of Vitamin B12		12 weeks from baseline
Secondary	Levels of Vitamin 25-OHD		Baseline
Secondary	Levels of Vitamin 25-OHD		12 weeks from baseline
Secondary	Levels of Methylmalonic Acid (MMA)		Baseline
Secondary	Levels of Methylmalonic Acid (MMA)		12 weeks from baseline
Secondary	Levels of Homocysteine (HCy)		Baseline
Secondary	Levels of Homocysteine (HCy)		12 weeks from baseline