Biodex Sit2Stand for Individuals With Cardiac Disease

St. Ambrose University

Status: Withdrawn

Conditions: Coronary Artery Disease; Heart Failure; Frail Elderly Syndrome

Treatments: Behavioral: Exercise using the Biodex Sit2Stand Trainer

Study type: Interventional

Funder types: Other

Identifiers

NCT03170011

1

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise using the Biodex Sit2Stand Trainer