Home Exercise Program for Homebound Older Adults

NCT ID: NCT04034888

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2024-05-30

Brief Summary

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Exercise can be beneficial for older adults by promoting health, delaying or reversing functional decline, reducing chronic disease risk, decreasing falls, increasing strength and stamina, improving ability to perform activities of daily living (ADL), and improving overall quality of life (QOL). Developing and implementing exercise programs for homebound older adults for whom traveling to routine clinic-based appointments may not be feasible or safe becomes critical. Homebound, older adults are at increased risk for recurrent hospitalization, use of emergency care, nursing home placement, and death. Indeed, one study shows patients had significantly higher risk of being admitted into a hospital or nursing home, higher mortality, and higher health care expenditures compared to those in a comparison group. The purpose of this pilot is to develop and implement a pragmatic and feasible intervention to improve physical functioning in older homebound adults with chronic mobility disability. Unfortunately, little is known about the feasibility and utility of pragmatic home-based exercise rehabilitation in older adults with severe mobility limitations.

The investigators propose to develop and implement an intervention targeting functional limitations in this population with mobility disability. Our overall goals are to maintain and restore physical functioning and QOL for older, homebound adults. This research carries direct benefits for these patients as even modest improvements in disabled older adults may translate into significantly better QOL, reduce disability, minimize or reverse gradual declines related to serious chronic disease, resort functional independence, and increase community living capacity. Thus, the specified objectives of finalizing and implementing a sustainable home-based exercise program have practical implications for disabled older adults. Were homebound patients even slightly higher in terms of functional capacity, it could provide a partial degree of functional independence, impacting QOL for both patients and caregivers.

Detailed Description

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The purpose of this study is to develop and implement a pragmatic and feasible intervention to improve physical functioning in older homebound adults with chronic mobility disability. Unfortunately, little is known about the feasibility and utility of pragmatic home-based exercise rehabilitation in older adults with severe mobility limitations.

The Specific Aims and Hypotheses of this proposal are:

Specific Aim #1: Using human-centered design methodologies, work with providers and patients to develop a feasible multi-component home exercise program targeting mobility, strength, and performance of task-oriented ADLs. Feasibility will be determined by assessing adherence and retention to the developed exercise program.

Hypothesis 1: The investigators hypothesize that a task-based exercise intervention can be feasibly delivered in the homes of homebound, older adults.

Specific Aim #2: Perform a feasibility study to better assess feasibility and determine the effect(s) of the home-based intervention created in Aim 1 on functional outcomes (primary outcome SPPB), mobility, and QOL changes in homebound older adults with mobility disability.

Hypothesis 2: The investigators hypothesize that the developed 12-week multi-component exercise intervention will improve performance of basic ADLs, functional mobility, and QOL; as well as outcomes related to patient satisfaction, emergency department visits, and hospitalization.

Conditions

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Aging

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Home Exercise Program (HEX)

Customized home exercise program

Group Type EXPERIMENTAL

HEX

Intervention Type BEHAVIORAL

HEX is a customized exercise program with components including: 1) controlled flexibility movements; 2) progressive ADL training focusing on bed mobility, bed to chair transfers, and indoor walking; 3) task-specific seated resistance training to improve ability to get out of bed and; 4) and balance exercises. Participants will be expected to perform their HEX program at least 2 times/week in their home and all individualized exercise sessions will be supervised by an Exercise Physiologist. Each exercise has four levels of difficulty, which will be progressed as tolerated throughout the 12-weeks. Seated resistance exercises were designed to target all the major muscle groups and will include the following: arm curls, shoulder raises (lateral/front), overhead arm raise, wrist curls, leg extensions, hip flexion, hip ab/adduction, sit-to-stands, torso rotation, and marching.

Interventions

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HEX

HEX is a customized exercise program with components including: 1) controlled flexibility movements; 2) progressive ADL training focusing on bed mobility, bed to chair transfers, and indoor walking; 3) task-specific seated resistance training to improve ability to get out of bed and; 4) and balance exercises. Participants will be expected to perform their HEX program at least 2 times/week in their home and all individualized exercise sessions will be supervised by an Exercise Physiologist. Each exercise has four levels of difficulty, which will be progressed as tolerated throughout the 12-weeks. Seated resistance exercises were designed to target all the major muscle groups and will include the following: arm curls, shoulder raises (lateral/front), overhead arm raise, wrist curls, leg extensions, hip flexion, hip ab/adduction, sit-to-stands, torso rotation, and marching.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Veteran enrolled in the Veterans Administration Medical Health Care System's Home- Based Primary Care Program
* Aged 65 years or older

Exclusion Criteria

* Paraplegia
* Life expectancy of less than 12 months
* Currently engaged in a physical therapy program
* Any medical condition(s) or contraindications precluding patient participation in the study as per medical judgement of study team
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Maryland, Baltimore

OTHER

Sponsor Role lead

Responsible Party

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Alyssa Stookey

Research Health Scientist (GRECC), Research Associate (SOM)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alyssa Stookey, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland School of Medicine and Baltimore VA Medical Center

Locations

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University of Maryland

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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UMaryland

Identifier Type: -

Identifier Source: org_study_id