NCT04034888

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 26, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

December 4, 2024

Status Verified

December 1, 2024

Enrollment Period

4.3 years

First QC Date

July 16, 2019

Last Update Submit

December 3, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Short Physical Performance Battery

    captures domains of strength, endurance, and balance and is highly predictive of disability. The SPPB score is based on timed measures of standing balance, walking speed, and ability to rise from a chair.

    Baseline, 6 weeks, 12 weeks

Secondary Outcomes (4)

  • Change in 30-second sit-to-stand test

    Baseline, 6 weeks, 12-weeks

  • Change in 30-second arm curl test

    Baseline, 6 weeks, 12-weeks

  • Change in Grip Strength

    Baseline, 6 weeks, 12 weeks

  • Change in Lower Extremity Strength

    Baseline, 6 weeks, 12 weeks

Other Outcomes (5)

  • Change in Mobility

    Baseline, 6 weeks, 12 weeks

  • Change in Barthel Index of Activities of Daily Living

    Baseline, 6 weeks, 12 weeks

  • Change in Life Space Activity (LAS)

    Baseline, 6 weeks, 12 weeks

  • +2 more other outcomes

Study Arms (1)

Home Exercise Program (HEX)

EXPERIMENTAL

Customized home exercise program

Behavioral: HEX

Interventions

HEXBEHAVIORAL

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.

Home Exercise Program (HEX)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Study Officials

  • Alyssa Stookey, PhD

    University of Maryland School of Medicine and Baltimore VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Health Scientist (GRECC), Research Associate (SOM)

Study Record Dates

First Submitted

July 16, 2019

First Posted

July 26, 2019

Study Start

February 1, 2020

Primary Completion

May 30, 2024

Study Completion

May 30, 2024

Last Updated

December 4, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

No individual participant data will be shared with other researchers outside of our study team.

Locations