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Biodex Sit2Stand for Individuals With Cardiac Disease

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03170011
Enrollment
0
Registered
2017-05-30
Start date
2017-06-01
Completion date
2017-09-15
Last updated
2019-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Frail Elderly Syndrome, Heart Failure

Keywords

Cardiac rehabilitation, Sit to Stand, Function

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.

Interventions

BEHAVIORALExercise 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

Sponsors

St. Ambrose University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

This cohort design study will examine the effects of a six week training program using the Biodex Sit2Stand Trainer.

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Short Physical Performance BatteryWeek 0 and Week 7Lower extremity functional assessment tool which include gait speed, sit to stand ability and static balance

Secondary

MeasureTime frameDescription
Change in Isometric knee extension strengthWeek 0 and Week 7Measured in 90 degrees of flexion with hand held dynamometer
Change in 10 meter gait speedWeek 0 and Week 7Self selected walking speed over 10 meters
Change in Six Minute Walk TestWeek 0 and Week 7Total distance ambulated during a 6 minute time period.
Change in HeartQoLWeek 0 and Week 7Quality of Life assessment tool
Change in MacNewWeek 0 and Week 7Quality of life assessment tool

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026