Biodex Sit2Stand for Individuals With Cardiac Disease

September 17, 2019 updated by: Michael Puthoff, St. Ambrose University

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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
Other Names:
  • Biodex Sit2Stand Trainer

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Ambrose University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2017

Primary Completion (Anticipated)

September 15, 2017

Study Completion (Anticipated)

September 15, 2017

Study Registration Dates

First Submitted

May 14, 2017

First Submitted That Met QC Criteria

May 26, 2017

First Posted (Actual)

May 30, 2017

Study Record Updates

Last Update Posted (Actual)

September 19, 2019

Last Update Submitted That Met QC Criteria

September 17, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1 (Other Identifier: Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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