Biodex Sit2Stand for Individuals With Cardiac Disease

Study Overview
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Brief Summary
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Patients with cardiac disease have been shown to have deficits in activities such as standing up from a chair. The Biodex Sit2Stand Trainer is a new device meant to improve sit to stand performance by providing a lifting force through the seat to help the individual stand. The amount of lift can be graded to help improve leg strength, endurance, and function over time. The device has the potential to be a form of training for those in cardiac rehabilitation who have limitations in standing from a chair.

Detailed Description
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Patients who are diagnosed with cardiovascular disease and enter cardiac rehabilitation present with limitations in activity and restrictions in their abilities to participate in society. Even after a standard course of cardiac rehabilitation, some individuals will still present with deficits. One area this is seen is the ability to stand up from a chair. A new device, the Biodex Sit2Stand Trainer, has been designed to help improve the standing movement in those with lower extremity weakness. The trainer provides a graded lift or push through the seat to help the participant reach a standing posture. This study will whether a six week training program using the trainer will lead to improvements in strength, function and quality of life for those individuals who have recently completed a cardiac rehabilitation program. This study is a pilot study to help determine the ideal dosage of training and identify any limitations in using the device with this population. Based on the results of this pilot work, a larger intervention study will be conducted to examine the effectiveness of the trainer in a cardiac rehabilitation program.

Official Title
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The Effects of the Biodex Sit2Stand Trainer on Function for Individuals With Cardiac Disease

Conditions
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Coronary Artery Disease, Frail Elderly Syndrome, Heart Failure

Intervention / Treatment
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* Behavioral: Exercise using the Biodex Sit2Stand Trainer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals nearing the end of their cardiac rehabilitation program will be asked to participate. Inclusion criteria include the following: Completion of a cardiac rehabilitation Ability to walk 50 feet independently with or without an assistive device Inability to stand from a standard chair five times without the use of their arms or unable to complete five sit to stands in less than 15 seconds. No major cardiac arrhythmias during cardiac rehabilitation sessions. Ability to attend 14 sessions over a 7-8 week period Exclusion Criteria: Not meeting inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This cohort design study will examine the effects of a six week training program using the Biodex Sit2Stand Trainer.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The training protocol will be include 12 sessions completed over six weeks following a periodization training format. Each session will last approximately 40 minutes. At first, training will focus on high volume, low intensity, self-selected velocity with a progression to high intensity, low volume, self-selected velocity ending with a focus on power training (moderate intensity, moderate volume, high velocity movement) over the six weeks of training. | Behavioral: Exercise using the Biodex Sit2Stand Trainer<br>* Week 1-2 - Focused on lower intensity, higher volume, comfortable/self-selected velocity Week 3-4 - Focus on higher intensity, lower volume, comfortable/self-selected velocity Week 5 - Focus on moderate intensity, moderate volume, transitioning to higher velocity Week 6 - Focus on moderate intensity, moderate volume, high velocity<br>* Other names: Biodex Sit2Stand Trainer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Short Physical Performance Battery | Lower extremity functional assessment tool which include gait speed, sit to stand ability and static balance | Week 0 and Week 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Isometric knee extension strength | Measured in 90 degrees of flexion with hand held dynamometer | Week 0 and Week 7 | 
| Change in 10 meter gait speed | Self selected walking speed over 10 meters | Week 0 and Week 7 | 
| Change in Six Minute Walk Test | Total distance ambulated during a 6 minute time period. | Week 0 and Week 7 | 
| Change in HeartQoL | Quality of Life assessment tool | Week 0 and Week 7 | 
| Change in MacNew | Quality of life assessment tool | Week 0 and Week 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac rehabilitation, Sit to Stand, Function