Meal Delivery + Exercise for Frailty

Overseen By Paola Robles Cordova

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Robust by FFP, Terminal illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Meal Delivery + Exercise for Frailty?

Research shows that combining exercise and nutrition interventions can improve physical function and dietary protein intake in older adults with frailty. A study found significant improvements in physical tests and protein intake after an 8-week program, suggesting that similar treatments may be effective. ^{1 2 3 4 5}

Is the combination of meal delivery and exercise safe for older adults?

Research on programs like Meals on Wheels combined with exercise shows they are generally safe for older adults, with participants reporting satisfaction and improvements in physical function and nutrition. Regular monitoring is recommended to ensure nutritional needs are met, especially for those at risk of malnutrition. ^{1 6 7 8 9}

How does the Meals plus exercise treatment for frailty differ from other treatments?

This treatment is unique because it combines home-delivered nutritious meals with a home-based exercise program, specifically targeting frailty in older adults. Unlike other treatments that may focus solely on medication or exercise, this approach addresses both nutrition and physical activity, which are crucial for improving strength and overall health in frail individuals. ^{6 7 8 10 11}

Research Team

Jessica Lee, MD,MS

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

This trial is for homebound older adults who are medically stable but frail or prefrail according to The Fried Frailty Phenotype. Participants must be able to walk, follow instructions, and not be in any other physical therapy programs or have terminal illnesses.

Inclusion Criteria

Frail or prefrail by The Fried Frailty Phenotype (FFP)

I usually can't leave my home without help.

My health condition is currently stable.

Exclusion Criteria

I may have trouble understanding or following instructions.

I cannot walk on my own.

I cannot use my arms or I am in physical or occupational therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a home-based exercise program administered through Meals on Wheels to improve gait speed and frailty status

12 weeks

Home-based intervention

Follow-up

Participants are monitored for changes in gait speed, frailty status, and serum biomarkers

4 weeks

Treatment Details

Interventions

• Meals only
• Meals plus exercise

Trial Overview The study is testing the impact of a home-based exercise program delivered with Meals on Wheels on walking speed and frailty status. It also examines changes in specific blood markers related to inflammation and stress before and after exercising.

Participant Groups

Group I: Meals plus exercise Experimental Treatment 1 Intervention

Group II: Meals only Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

The MoveStrong program, an 8-week exercise and nutrition intervention delivered via telephone and virtual sessions, was feasible and well-accepted by older adults, with a high retention rate of 93% and adherence to sessions exceeding 80%.

Participants showed significant improvements in physical function, as evidenced by increased chair stand test scores and enhanced dietary protein intake, indicating the program's effectiveness in addressing frailty in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MoveStrong at home: a feasibility study of a model for remote delivery of functional strength and balance training combined with nutrition education for older pre-frail and frail adults. Wang, E., Keller, H., Mourtzakis, M., et al.[2022]

Combined exercise and nutrition interventions for hospitalized older adults (≥65 years) show a weak but positive effect on reducing frailty scores and improving physical performance, as evidenced by a meta-analysis of 11 randomized controlled trials involving 20 articles.

Participants receiving these interventions demonstrated greater independence in daily activities, although the results showed high variability, indicating that while there are benefits, the effectiveness may differ significantly among individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of combined exercise and nutrition interventions in prefrail or frail older hospitalised patients: a systematic review and meta-analysis. Han, CY., Miller, M., Yaxley, A., et al.[2021]

In a study involving 300 older adults (average age 82.5 years) with signs of frailty, it was found that greater severity of frailty is linked to lower functional independence and health-related quality of life (HRQoL).

The participants were randomized into a 12-month home-based exercise program or usual care, highlighting the potential for supervised physical activity to improve outcomes for frail individuals, although the results of the intervention are not detailed in this abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Older persons with signs of frailty in a home-based physical exercise intervention: baseline characteristics of an RCT. Suikkanen, S., Soukkio, P., Pitkälä, K., et al.[2022]

A 12-month home-based exercise program significantly improved physical performance, as measured by the Short Physical Performance Battery (SPPB), in frail individuals aged 65 and older, compared to usual care.

Participants in the exercise group experienced nearly half the number of falls per person-year compared to those receiving usual care, indicating that the exercise program effectively reduced fall risk among frail older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of 12-Month Supervised, Home-Based Physical Exercise on Functioning Among Persons With Signs of Frailty: A Randomized Controlled Trial. Suikkanen, S., Soukkio, P., Aartolahti, E., et al.[2021]

A systematic review of the ClinicalTrials.gov registry identified various ongoing or completed trials targeting frailty in older adults, highlighting the importance of measuring frailty as a predictor of health outcomes, especially in those with cardiovascular disease.

The review covered a range of interventions, including exercise training, nutritional supplementation, and pharmaceutical agents, indicating a diverse approach to addressing frailty, although the number of published trials remains limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic interventions for frail elderly patients: part II. Ongoing and unpublished randomized trials. Bendayan, M., Bibas, L., Levi, M., et al.[2022]

A pilot study involving 12 Meals on Wheels clients showed that providing high protein, high energy snacks significantly improved nutritional status, with a notable increase in energy and protein intake, and a reduction in the number of clients categorized as malnourished.

The study found that while the additional snacks led to increased body weight and BMI, only half of the participants expressed interest in continuing the program, indicating that not all clients recognized the benefits of the snacks for their health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"It could probably help someone else but not me": a feasibility study of a snack programme offered to meals on wheels clients. Charlton, KE., Walton, K., Moon, L., et al.[2021]

In a study of 250 older South Australians, those receiving 'Meals on Wheels' (MOW) did not show significant differences in health outcomes or hospital admissions compared to those not receiving MOW, despite both groups being poorly nourished.

While MOW did not prevent weight loss or hospital admissions, it may still have a role in reducing hospital stays for nutritionally vulnerable older adults, suggesting further investigation is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospital admissions in poorly nourished, compared with well-nourished, older South Australians receiving 'Meals on Wheels': findings from a pilot study. Luscombe-Marsh, N., Chapman, I., Visvanathan, R.[2014]

A study of 42 Meals on Wheels clients in Australia found that while their average daily energy intake was similar to estimated requirements, their protein intake was significantly higher than needed, indicating that protein intake may not be a concern for most clients.

However, 16 clients were identified as at risk of malnutrition, consuming significantly less energy and protein than well-nourished clients, highlighting the need for regular nutritional screening and monitoring in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The nutritional status and energy and protein intakes of MOW clients and the need for further targeted strategies to enhance intakes. Walton, K., Charlton, KE., Manning, F., et al.[2015]

A frailty index (FI) calculated from self-reported health and nutrition data of 258 Meals on Wheels clients provides valuable insights for care planning and risk assessment, with an average FI of 0.29 indicating varying levels of frailty.

The FI offers a more comprehensive view of client health compared to nutrition risk alone, highlighting the importance of integrating multiple health factors for better support of older adults with advanced care needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frailty and Nutrition Risk Screening in Home-Delivered Meal Clients. Hutchins-Wiese, HL., Walsh, SE.[2020]

A community-based project in Birmingham, Alabama successfully increased volunteer participation in the Meals on Wheels program by leveraging existing social networks within religious faith communities, resulting in a sustainable meal delivery route for vulnerable older adults.

The initiative created a volunteer route that served over 2000 meals in its first year and continues to operate, demonstrating the effectiveness of using theoretical frameworks in planning community interventions to address food insecurity among socially isolated seniors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recruitment of volunteers for a home-delivered meals programme serving homebound older adults: a theoretically derived programme among faith communities. Buys, DR., Marler, ML., Robinson, CO., et al.[2019]

There was a decline in the number of referrals to the Meals on Wheels service from hospitals between 2008 and 2012, indicating a potential gap in access for older adults.

The most popular meal choice, the 'main meal' alone, failed to meet the energy and protein requirements for men and did not fully satisfy the nutritional needs for women unless combined with soup and dessert, highlighting the need for improved meal options that align with nutritional guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meals on Wheels: Who's referring and what's on the menu? Charlton, KE., Tjong, M., North, J., et al.[2020]

References

1. Canada pubmed.ncbi.nlm.nih.gov

MoveStrong at home: a feasibility study of a model for remote delivery of functional strength and balance training combined with nutrition education for older pre-frail and frail adults. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Effectiveness of combined exercise and nutrition interventions in prefrail or frail older hospitalised patients: a systematic review and meta-analysis. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Older persons with signs of frailty in a home-based physical exercise intervention: baseline characteristics of an RCT. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of 12-Month Supervised, Home-Based Physical Exercise on Functioning Among Persons With Signs of Frailty: A Randomized Controlled Trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Therapeutic interventions for frail elderly patients: part II. Ongoing and unpublished randomized trials. [2022]

6. France pubmed.ncbi.nlm.nih.gov

"It could probably help someone else but not me": a feasibility study of a snack programme offered to meals on wheels clients. [2021]

7. Australia pubmed.ncbi.nlm.nih.gov

Hospital admissions in poorly nourished, compared with well-nourished, older South Australians receiving 'Meals on Wheels': findings from a pilot study. [2014]

8. England pubmed.ncbi.nlm.nih.gov

The nutritional status and energy and protein intakes of MOW clients and the need for further targeted strategies to enhance intakes. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

Frailty and Nutrition Risk Screening in Home-Delivered Meal Clients. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Recruitment of volunteers for a home-delivered meals programme serving homebound older adults: a theoretically derived programme among faith communities. [2019]

11. Australia pubmed.ncbi.nlm.nih.gov

Meals on Wheels: Who's referring and what's on the menu? [2020]