Clinical trial NCT03170011: Biodex Sit2Stand for Individuals With Cardiac Disease
Official title: The Effects of the Biodex Sit2Stand Trainer on Function for Individuals With Cardiac Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Coronary Artery Disease
Frail Elderly Syndrome
Heart Failure
Keywords: Cardiac rehabilitation
Sit to Stand
Function
Lead sponsor: St. Ambrose University
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This cohort design study will examine the effects of a six week training program using the Biodex Sit2Stand Trainer.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Short Physical Performance Battery
timeFrame: Week 0 and Week 7
Secondary outcomes:
measure: Change in Isometric knee extension strength
timeFrame: Week 0 and Week 7
measure: Change in 10 meter gait speed
timeFrame: Week 0 and Week 7
measure: Change in Six Minute Walk Test
timeFrame: Week 0 and Week 7
measure: Change in HeartQoL
timeFrame: Week 0 and Week 7
measure: Change in MacNew
timeFrame: Week 0 and Week 7
Other outcomes:
Locations:
Study officials:
References:
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citation: Goel K, Shen J, Wolter AD, Beck KM, Leth SE, Thomas RJ, Squires RW, Perez-Terzic CM. Prevalence of musculoskeletal and balance disorders in patients enrolled in phase II cardiac rehabilitation. J Cardiopulm Rehabil Prev. 2010 Jul-Aug;30(4):235-9. doi: 10.1097/HCR.0b013e3181e17387.
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citation: Puthoff ML, Youngs B. Cardiac Rehabilitation Leads to Improvements in Activity Limitations. J Cardiopulm Rehabil Prev. 2017 Nov;37(6):424-427. doi: 10.1097/HCR.0000000000000220.