Impact of a Mobility Program

NCT02674503 | Completed Results DMC

• 1 other identifier: E1995-R
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 2

Brief Summary

After hospitalization, many older adults experience more difficulty getting around in the community and performing one or more of their basic activities of daily living (ADLs) like bathing or dressing. The goals of this study are to test the effectiveness of a mobility intervention, compared to usual care, on change in mobility after hospitalization, to determine the impact on one-year outcomes such as nursing home placement and to identify which Veterans benefit the most from the intervention. Ultimately, the goal is to improve recovery after hospitalization and reduce disability in hospitalized Veterans.

Conditions

Hospitalization

Keywords

Walking; Hospitalization; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Life-Space Assessment Score

  The UAB Study of Aging Life-Space Assessment (LSA) is a validated tool that measures mobility and function based on the distance which a person reports moving during the four weeks preceding the assessment. The range in scores is 0-100 with higher scores representing better life space mobility.

  One year

Secondary Outcomes (12)

• Presence of Adverse Outcomes: Rehospitalization

  One Year

• Presence of Adverse Outcomes: Nursing Home Placement

  One year

• Presence of Adverse Outcomes: Death

  One year

• Activities of Daily Living (ADLs)

  One Year

• Presence of Adverse Outcomes (ED Visits, Rehospitalization, Nursing Home Placement, Death)

  One year

Study Arms (2)

Intensive

EXPERIMENTAL

MP patients will participate in a program of progressive walking and transfer training up to three times a day, seven days a week throughout the hospital stay.

Behavioral: Walking

Friendly visit

PLACEBO COMPARATOR

UC patients will receive three times a day "friendly visits", seven days a week by members of the research team to control for the daily attention that MP patients receive.

Behavioral: Friendly visit

Interventions

Walking BEHAVIORAL

MP patients will participate in a program of progressive walking and transfer training up to three times a day, seven days a week throughout the hospital stay. MP patients will begin with assisted sitting, then standing, progressing to weight shifting and stepping in place, and then to walking as tolerated. The level of mobility recommended to the MP patient by the Walker will be dependent on the individual patient and will incorporate the activities patients were deemed able to do independent of cueing or assistance during each walking session.

Intensive

Friendly visit BEHAVIORAL

UC patients will receive three times a day "friendly visits", seven days a week by members of the research team to control for the daily attention that MP patients receive.

Friendly visit

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50 years admitted to one of the five hospital wards of the Birmingham VA Medical Center (VAMC) for any medical illness, e.g.:
• Pneumonia
• Heart failure
• Chronic obstructive pulmonary disease (COPD) exacerbation
• Or other medical (versus surgical) indication for hospitalization
• Patients will be recruited within 48 hours of hospitalization, followed throughout their hospitalization and for one year after hospital discharge.

You may not qualify if:

• Patients admitted for brief observation will be excluded, e.g.:
• hour observation for possible myocardial infarction
• Inability to walk across a small room 2 weeks prior to admission
• Inability to walk safely with assistance, based on a strength and balance screen (see Training of Walkers, below for details)
• Having a pulmonary embolus, unstable angina or other medical diagnosis deemed by the primary physician to be a contraindication to walking
• Being on hospice or comfort care
• Being in a semi-private room with another currently enrolled participant
• Non-English speaking, blind, or deaf

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Birmingham VA Medical Center, Birmingham, AL

Birmingham, Alabama, 35233, United States

Location

UAB Hospital

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Interventions

Walking

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Limitations and Caveats

Study recruitment did not meet the calculated sample size target of 258 participants.

Results Point of Contact

• Title: Dr. Alayne Markland
• Organization: Birmingham VA - GRECC Director; Professor at UAB

alayne.markland@va.gov

205-558-7067

Study Officials

• Cynthia J Brown, MD MSPH

  Birmingham VA Medical Center, Birmingham, AL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: February 4, 2016
• Study Start: December 12, 2016
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: July 5, 2024
• Results First Posted: July 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

US (2)