Biodex Sit2Stand for Individuals With Cardiac Disease

NCT03170011 | Withdrawn

• 1 other identifier: 1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Disease; Frail Elderly Syndrome; Heart Failure

Keywords

Cardiac rehabilitation; Sit to Stand; Function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Isometric knee extension strength

  Week 0 and Week 7

• Change in 10 meter gait speed

  Week 0 and Week 7

• Change in Six Minute Walk Test

  Week 0 and Week 7

• Change in HeartQoL

  Week 0 and Week 7

• Change in MacNew

  Week 0 and Week 7

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

Exercise using the Biodex Sit2Stand Trainer BEHAVIORAL

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

Also known as: Biodex Sit2Stand Trainer

Intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• St. Ambrose University: lead

Related Publications (6)

• Jensen KH, Baekgaard N, Gaardsting O, Jelnes R, Tonnesen KH. [The social consequences of intermittent claudication]. Ugeskr Laeger. 1986 Oct 13;148(42):2715-7. No abstract available. Danish.

  PMID: 3787784 RESULT

• 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.0b013e3181b4ca61.

  PMID: 19935142 RESULT

• 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.

  PMID: 20068420 RESULT

• 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.

  PMID: 20551829 RESULT

• 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. doi: 10.1001/archinte.159.19.2357.

  PMID: 10547176 RESULT

• 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.

  PMID: 28033164 RESULT

MeSH Terms

Conditions

Coronary Artery Disease; Heart Failure

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: May 14, 2017
• First Posted: May 30, 2017
• Study Start: June 1, 2017
• Primary Completion: September 15, 2017
• Study Completion: September 15, 2017
• Last Updated: September 19, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share