An interventional study of Exercise using the Biodex Sit2Stand Trainer in Coronary Artery Disease, Frail Elderly Syndrome and Heart Failure, sponsored by St. Ambrose University. Withdrawn. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-09-19.
Sponsored by St. Ambrose University · Not applicable, Interventional, and Treatment
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.
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.
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Individuals nearing the end of their cardiac rehabilitation program will be asked to participate. Inclusion criteria include the following:
Exclusion Criteria:
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
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
Also known as: Biodex Sit2Stand Trainer
Change in Short Physical Performance Battery
Lower extremity functional assessment tool which include gait speed, sit to stand ability and static balance
Time frame: Week 0 and Week 7
Change in Isometric knee extension strength
Measured in 90 degrees of flexion with hand held dynamometer
Time frame: Week 0 and Week 7
Change in 10 meter gait speed
Self selected walking speed over 10 meters
Time frame: Week 0 and Week 7
Change in Six Minute Walk Test
Total distance ambulated during a 6 minute time period.
Time frame: Week 0 and Week 7
Change in HeartQoL
Quality of Life assessment tool
Time frame: Week 0 and Week 7
Change in MacNew
Quality of life assessment tool
Time frame: Week 0 and Week 7
No study locations are listed for this record.
Plan to share: No
This study is withdrawn, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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St. Ambrose University