Effects of a Falls Prevention Program Following Hospital Discharge

NCT02995486 | Completed

• 1 other identifier: IRB-15-0442
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, control trial will be conducted to evaluate the effects of a post-discharge falls prevention program in patients with neurological diseases and disorders. The objective of this study is to evaluate if implementing a falls prevention program is effective in reducing subsequent falls and re-hospitalizations, and improving gait, strength and balance in older adults after hospital discharge. Patients from Baptist Health Neuroscience Center will be randomized on the day of discharge to receive an exercise falls prevention program, delivered by Baptist Health physical therapists, or an educational pamphlet on falls prevention. Baseline and follow up assessments for gait, balance, and strength will be completed at regular intervals to examine effects of the exercise program. In addition, participants will be surveyed to find out about recent falls and hospitalizations. This is a minimal risk study such that the assessments involve conditions in which subjects likely encounter on a daily basis. The risks of the exercise intervention also are no more than one might expect from a community exercise program. Potential benefits include reduced hospitalizations and/or emergency visits related to falls in the intervention group, increased activity levels and improved falls efficacy in the intervention group, and increased system capacity at Baptist Health to deliver a falls prevention program.

Conditions

Accidental Fall

Outcome Measures

Primary Outcomes (1)

• Self-reported subsequent falls

  12 months

Secondary Outcomes (13)

• Number of re-hospitalizations

  12 months

• Gait velocity in cm/s from a GaitRite instrumented mat

  12 months

• Grip strength in N using a Jamar

  12 months

• Tinneti Balance Assessment scores

  12 months

• Falls Efficacy Scale scores

  12 months

Study Arms (2)

Control

NO INTERVENTION

Standard care with only an educational pamphlet.

Intervention

EXPERIMENTAL

Post-discharge exercise group

Other: Exercise

Interventions

Exercise OTHER

Otago Exercise Program for falls prevention after discharge due to fall-related injuries.

Intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Discharged from the hospital after being treated for a fall-related injury;
• Able to engage in an exercise program for falls prevention (sufficient physical and cognitive health);
• Competent to provide consent.

You may not qualify if:

• Wheelchair bound;
• Has contraindications for engaging in an exercise program based on the patient records;
• Does not pass the Mini Cog test (brief cognitive screening tool)
• Does not have reliable transportation for follow-up visits.

Sponsors & Collaborators

• Florida International University: lead
• Baptist Health South Florida: collaborator

Study Sites (1)

Baptist Hospital

Miami, Florida, 33176, United States

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

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

Study Officials

• Edgar R Vieira

  Florida International University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: December 16, 2016
• Study Start: November 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

US (1)