Working to Increase Stability Through Exercise

Summary

The investigators propose a 36-month multi-center randomized effectiveness trial to compare the impact of an Enhanced Usual Care (Control) intervention, with Exercise Coaching (Exercise), on Serious Fall-Related Injuries (SFI) in patients with a previous fragility fracture (FF).

The investigators will also examine the impact of the intervention on several secondary outcomes like: loneliness, physical function, and bone strength. The investigators will do this by following a Pragmatic trial design: 1) limiting exclusions to increase representativeness, 2) limiting research contacts (average 30 min/year) and 3) limiting measures to those practicable for use in usual care.

Conditions

• Fractures, Bone
• Serious Fall-related Injuries

Interventions

BEHAVIORAL

Enhanced Usual Care plus Exercise Coaching

For month one of the exercise intervention the investigators will conduct only strength and a few balance exercises to rehabilitate the participants. After the first month, and once the participants feel comfortable, the investigators will incorporate aerobic and additional balance exercises. The investigators will personalize participant programs based on baseline levels and increase them gradually. The exercise session will be conducted 50 minutes 3 times a week. Between sets there is a 60-second break. Every month the coach will record steps from the pedometer and record patient adherence to exercise sessions, and every 2 months the coach will measure strength and will track resistance band color from the exercise trackers. For the individuals exercising at home, the investigators will distribute the exercise Digital Versatile Disc (DVDs) every 9 months and the coach will continue to contact them, just as if they were joining the group. Coaches will encourage group participation.

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• Temple University

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Columbia University

  collaborator OTHER

• University of Illinois at Chicago

  collaborator OTHER

• Milton S. Hershey Medical Center

  lead OTHER

Principal Investigators

• Christopher Sciamanna, MD, MPH · Milton S. Hershey Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-11-21

Primary Completion

2021-12-17

Completion

2021-12-17

Countries

• United States

Study Locations