Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Efficacy of a Post-Rehabilitation Exercise Intervention
Brief Summary: Background:

Many people who have suffered a hip fracture are discharged from rehabilitation services with significant residual functional limitations and disability. We believe that a home-based exercise program that incorporates cognitive-behavioral techniques to increase exercise adherence and promote the return to daily activities could extend the benefits of formal rehabilitation for patients who have suffered a hip fracture.

Specific Aims:

We will conduct a 5-year multi-site randomized controlled trial in patients who have suffered a recent hip fracture and have completed all rehabilitation services. The specific aim that this project will address is whether:

Participation in the Strong for Life (SFL) program will improve function and disability outcomes in participants 6-months after they are discharged from rehabilitation services.

This study will also investigate the following secondary hypotheses:

1. Changes in function and disability at 6-month follow-up will be correlated with changes in all three proposed intermediary variables: muscle strength, balance, and self-efficacy.
2. The SFL program will significantly improve health-related quality of life among participants at 6-month follow-up.
3. At 9-month follow-up the SFL program will continue to have a significant impact on participants' function and disability compared to the control group.

Target population:

The target population will be people aged 60 years or more who have suffered a recent traumatic hip fracture, have one or more residual functional limitations and have completed all inpatient, outpatient or homecare rehabilitation services.

Intervention:

We will use an enhanced version of the Strong for Life program. This home-based exercise program will include both resistance exercises using Thera-bands that will be shown on a video/DVD and weight-bearing exercises that are progressed using a step and/or a weighted vest. A cognitive-behavioral program that is customized for people recovering from hip fracture is being developed that will focus on promoting exercise adherence, decreasing fear of falling and increasing the return to daily activities in the patient's home and community.

Design:

A randomized controlled clinical trial will be implemented to measure the efficacy of the Strong for Life program. An attention-control intervention will be provided to all participants assigned to the control group. The outcome evaluation points are:

* T0: baseline, at the point of discharge from formal rehabilitation;
* T2: 6-month outcome assessment
* T3: 9-month follow-up

Outcomes:

The primary outcomes will be function measured by both self-report (AM PAC) and physical performance measures (SPPB). Secondary outcomes include disability, self-efficacy, balance, strength, cognition, and reaction time. Adherence to the exercise program and adverse events will also be monitored.


Options:
A: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Behavioral: Enhanced Strong for Life | Arm Label: cardiovascular education (attention control); Type: PLACEBO_COMPARATOR; Interventions: Behavioral: cardiovascular nutrition education | Intervention Type: BEHAVIORAL; Name: Enhanced Strong for Life; Assigned to Arm(s): 1 | Intervention Type: BEHAVIORAL; Name: cardiovascular nutrition education; Assigned to Arm(s): cardiovascular education (attention control)
B: Arm Label: Conventional rehabilitation; Type: ACTIVE_COMPARATOR; Interventions: Other: Conventional rehabilitation | Arm Label: Aerobic exercise; Type: ACTIVE_COMPARATOR; Interventions: Other: Conventional rehabilitation, Other: Aerobic exercise | Intervention Type: OTHER; Name: Conventional rehabilitation; Assigned to Arm(s): Aerobic exercise, Conventional rehabilitation | Intervention Type: OTHER; Name: Aerobic exercise; Assigned to Arm(s): Aerobic exercise
C: Intervention Type: DRUG; Name: cholecalciferol; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: Physiotherapy; Assigned to Arm(s): N/A
D: Intervention Type: DRUG; Name: MK0677; Assigned to Arm(s): N/A

Answer: A