Biodex Sit2Stand for Individuals With Cardiac Disease

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03170011
• Other study ID #: 1
• Status: Withdrawn
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: September 15, 2017

Study information

• Verified date: September 2019
• Source: St. Ambrose University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 15, 2017
• Est. primary completion date: September 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Frail Elderly Syndrome
• Heart Diseases
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
St. Ambrose University

References & Publications (6)

Ades PA, Maloney A, Savage P, Carhart RL Jr. Determinants of physical functioning in coronary patients: response to cardiac rehabilitation. Arch Intern Med. 1999 Oct 25;159(19):2357-60. — View 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. — View Citation

Jensen KH, Baekgaard N, Gaardsting O, Jelnes R, Tønnesen KH. [The social consequences of intermittent claudication]. Ugeskr Laeger. 1986 Oct 13;148(42):2715-7. Danish. — View 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. — View Citation

Stevenson TG, Riggin K, Nagelkirk PR, Hargens TA, Strath SJ, Kaminsky LA. Physical activity habits of cardiac patients participating in an early outpatient rehabilitation program. J Cardiopulm Rehabil Prev. 2009 Sep-Oct;29(5):299-303. doi: 10.1097/HCR.0b0 — View Citation

Zullo MD, Dolansky MA, Jackson LW. Cardiac rehabilitation, health behaviors, and body mass index post-myocardial infarction. J Cardiopulm Rehabil Prev. 2010 Jan-Feb;30(1):28-34. doi: 10.1097/HCR.0b013e3181c8594b. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Short Physical Performance Battery	Lower extremity functional assessment tool which include gait speed, sit to stand ability and static balance	Week 0 and Week 7
Secondary	Change in Isometric knee extension strength	Measured in 90 degrees of flexion with hand held dynamometer	Week 0 and Week 7
Secondary	Change in 10 meter gait speed	Self selected walking speed over 10 meters	Week 0 and Week 7
Secondary	Change in Six Minute Walk Test	Total distance ambulated during a 6 minute time period.	Week 0 and Week 7
Secondary	Change in HeartQoL	Quality of Life assessment tool	Week 0 and Week 7
Secondary	Change in MacNew	Quality of life assessment tool	Week 0 and Week 7