Clinical trial NCT04034888: Home Exercise Program for Homebound Older Adults
Official title: Home Exercise Program for Homebound Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 19
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Short Physical Performance Battery
timeFrame: Baseline, 6 weeks, 12 weeks
Secondary outcomes:
measure: Change in 30-second sit-to-stand test
timeFrame: Baseline, 6 weeks, 12-weeks
measure: Change in 30-second arm curl test
timeFrame: Baseline, 6 weeks, 12-weeks
measure: Change in Grip Strength
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in Lower Extremity Strength
timeFrame: Baseline, 6 weeks, 12 weeks
Other outcomes:
measure: Change in Mobility
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in Barthel Index of Activities of Daily Living
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in Life Space Activity (LAS)
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Late-Life Function and Disability Instrument (LLFDI)
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in Quality of Life
timeFrame: Baseline, 6 weeks, 12 weeks
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
Study officials:
affiliation: University of Maryland School of Medicine and Baltimore VA Medical Center
name: Alyssa Stookey, PhD
role: PRINCIPAL_INVESTIGATOR
References: