Frailty
Conditions
Keywords
homebound patients, exercise, nutrition
Brief 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.
Interventions
BEHAVIORALMeals 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.
BEHAVIORALMeals 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.
Sponsors
National Center for Advancing Translational Sciences (NCATS)
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Frailty Status as Assessed by the Fried Frailty Phenotype (FFP) Screening Test. | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Levels of Serum Folate | Baseline |
| Levels of Vitamin B12 | Baseline |
| Levels of Plasma Vitamin C | baseline |
| Levels of Methylmalonic Acid (MMA) | Baseline |
| Levels of Homocysteine (HCy) | Baseline |
| Levels of Vitamin 25-OHD | Baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Meals Only 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. | 4 |
| Meals Plus Exercise 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. | 5 |
| Total | 9 |
Baseline characteristics
| Characteristic | Meals Only | Meals Plus Exercise | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 4 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 1 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 5 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 4 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 5 |
| other Total, other adverse events | 2 / 4 | 2 / 5 |
| serious Total, serious adverse events | 1 / 4 | 1 / 5 |
Outcome results
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.
Time frame: baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Meals Only | Overall Frailty Status as Assessed by the Fried Frailty Phenotype (FFP) Screening Test. | Frail | 2 Participants |
| Meals Only | Overall Frailty Status as Assessed by the Fried Frailty Phenotype (FFP) Screening Test. | Prefrail | 2 Participants |
| Meals Only | Overall Frailty Status as Assessed by the Fried Frailty Phenotype (FFP) Screening Test. | Robust | 0 Participants |
| Meals Plus Exercise | Overall Frailty Status as Assessed by the Fried Frailty Phenotype (FFP) Screening Test. | Frail | 2 Participants |
| Meals Plus Exercise | Overall Frailty Status as Assessed by the Fried Frailty Phenotype (FFP) Screening Test. | Prefrail | 3 Participants |
| Meals Plus Exercise | Overall Frailty Status as Assessed by the Fried Frailty Phenotype (FFP) Screening Test. | Robust | 0 Participants |
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.
Time frame: 12 weeks after study initiation
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Meals Only | Overall Frailty Status as Assessed by the Fried Frailty Phenotype (FFP) Screening Test. | Frail | 2 Participants |
| Meals Only | Overall Frailty Status as Assessed by the Fried Frailty Phenotype (FFP) Screening Test. | Prefrail | 2 Participants |
| Meals Only | Overall Frailty Status as Assessed by the Fried Frailty Phenotype (FFP) Screening Test. | Robust | 0 Participants |
| Meals Plus Exercise | Overall Frailty Status as Assessed by the Fried Frailty Phenotype (FFP) Screening Test. | Frail | 1 Participants |
| Meals Plus Exercise | Overall Frailty Status as Assessed by the Fried Frailty Phenotype (FFP) Screening Test. | Prefrail | 4 Participants |
| Meals Plus Exercise | Overall Frailty Status as Assessed by the Fried Frailty Phenotype (FFP) Screening Test. | Robust | 0 Participants |
Secondary
Levels of Homocysteine (HCy)
Time frame: 12 weeks from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meals Only | Levels of Homocysteine (HCy) | 18.83 pml/uL | Standard Deviation 6.83 |
| Meals Plus Exercise | Levels of Homocysteine (HCy) | 21.24 pml/uL | Standard Deviation 5.81 |
Secondary
Levels of Homocysteine (HCy)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meals Only | Levels of Homocysteine (HCy) | 19.20 pmol/uL | Standard Deviation 3.93 |
| Meals Plus Exercise | Levels of Homocysteine (HCy) | 18.21 pmol/uL | Standard Deviation 7.94 |
Secondary
Levels of Methylmalonic Acid (MMA)
Time frame: 12 weeks from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meals Only | Levels of Methylmalonic Acid (MMA) | 554.55 pg/mL | Standard Deviation 511.1 |
| Meals Plus Exercise | Levels of Methylmalonic Acid (MMA) | 388.75 pg/mL | Standard Deviation 161.44 |
Secondary
Levels of Methylmalonic Acid (MMA)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meals Only | Levels of Methylmalonic Acid (MMA) | 533.64 pg/mL | Standard Deviation 420.41 |
| Meals Plus Exercise | Levels of Methylmalonic Acid (MMA) | 406.93 pg/mL | Standard Deviation 179.8 |
Secondary
Levels of Plasma Vitamin C
Time frame: 12 weeks from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meals Only | Levels of Plasma Vitamin C | 3738.89 ng/L | Standard Deviation 2714.39 |
| Meals Plus Exercise | Levels of Plasma Vitamin C | 2055.56 ng/L | Standard Deviation 304.29 |
Secondary
Levels of Plasma Vitamin C
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meals Only | Levels of Plasma Vitamin C | 2616.67 ng/L | Standard Deviation 2334.11 |
| Meals Plus Exercise | Levels of Plasma Vitamin C | 1180.56 ng/L | Standard Deviation 73.49 |
Secondary
Levels of Serum Folate
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meals Only | Levels of Serum Folate | 20.32 ug/L | Standard Deviation 18.67 |
| Meals Plus Exercise | Levels of Serum Folate | 10.50 ug/L | Standard Deviation 1.52 |
Secondary
Levels of Serum Folate
Time frame: 12 weeks from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meals Only | Levels of Serum Folate | 19.56 ug/L | Standard Deviation 13.96 |
| Meals Plus Exercise | Levels of Serum Folate | 10.85 ug/L | Standard Deviation 3.57 |
Secondary
Levels of Vitamin 25-OHD
Time frame: 12 weeks from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meals Only | Levels of Vitamin 25-OHD | 126.72 ug/L | Standard Deviation 120.6 |
| Meals Plus Exercise | Levels of Vitamin 25-OHD | 61.68 ug/L | Standard Deviation 17.92 |
Secondary
Levels of Vitamin 25-OHD
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meals Only | Levels of Vitamin 25-OHD | 120.75 ug/L | Standard Deviation 93.16 |
| Meals Plus Exercise | Levels of Vitamin 25-OHD | 86.41 ug/L | Standard Deviation 33.02 |
Secondary
Levels of Vitamin B12
Time frame: 12 weeks from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meals Only | Levels of Vitamin B12 | 875.42 ng/L | Standard Deviation 557.59 |
| Meals Plus Exercise | Levels of Vitamin B12 | 528.44 ng/L | Standard Deviation 160.04 |
Secondary
Levels of Vitamin B12
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meals Only | Levels of Vitamin B12 | 839.17 ng/L | Standard Deviation 593.41 |
| Meals Plus Exercise | Levels of Vitamin B12 | 575.83 ng/L | Standard Deviation 139.65 |