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Biodex Sit2Stand for Individuals With Cardiac Disease

Primary Purpose

Coronary Artery Disease, Frail Elderly Syndrome, Heart Failure

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise using the Biodex Sit2Stand Trainer
Sponsored by
St. Ambrose University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Cardiac rehabilitation, Sit to Stand, Function

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention

    Arm 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.

    Outcomes

    Primary Outcome Measures

    Change in Short Physical Performance Battery
    Lower extremity functional assessment tool which include gait speed, sit to stand ability and static balance

    Secondary Outcome Measures

    Change in Isometric knee extension strength
    Measured in 90 degrees of flexion with hand held dynamometer
    Change in 10 meter gait speed
    Self selected walking speed over 10 meters
    Change in Six Minute Walk Test
    Total distance ambulated during a 6 minute time period.
    Change in HeartQoL
    Quality of Life assessment tool
    Change in MacNew
    Quality of life assessment tool

    Full Information

    First Posted
    May 14, 2017
    Last Updated
    September 17, 2019
    Sponsor
    St. Ambrose University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03170011
    Brief Title
    Biodex Sit2Stand for Individuals With Cardiac Disease
    Official Title
    The Effects of the Biodex Sit2Stand Trainer on Function for Individuals With Cardiac Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Unable to enroll any participants.
    Study Start Date
    June 1, 2017 (Anticipated)
    Primary Completion Date
    September 15, 2017 (Anticipated)
    Study Completion Date
    September 15, 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    St. Ambrose University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Artery Disease, Frail Elderly Syndrome, Heart Failure
    Keywords
    Cardiac rehabilitation, Sit to Stand, Function

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    This cohort design study will examine the effects of a six week training program using the Biodex Sit2Stand Trainer.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Exercise using the Biodex Sit2Stand Trainer
    Other Intervention Name(s)
    Biodex Sit2Stand Trainer
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Change in Short Physical Performance Battery
    Description
    Lower extremity functional assessment tool which include gait speed, sit to stand ability and static balance
    Time Frame
    Week 0 and Week 7
    Secondary Outcome Measure Information:
    Title
    Change in Isometric knee extension strength
    Description
    Measured in 90 degrees of flexion with hand held dynamometer
    Time Frame
    Week 0 and Week 7
    Title
    Change in 10 meter gait speed
    Description
    Self selected walking speed over 10 meters
    Time Frame
    Week 0 and Week 7
    Title
    Change in Six Minute Walk Test
    Description
    Total distance ambulated during a 6 minute time period.
    Time Frame
    Week 0 and Week 7
    Title
    Change in HeartQoL
    Description
    Quality of Life assessment tool
    Time Frame
    Week 0 and Week 7
    Title
    Change in MacNew
    Description
    Quality of life assessment tool
    Time Frame
    Week 0 and Week 7

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    3787784
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    19935142
    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.0b013e3181b4ca61.
    Results Reference
    result
    PubMed Identifier
    20068420
    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.
    Results Reference
    result
    PubMed Identifier
    20551829
    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: 10.1097/HCR.0b013e3181e17387.
    Results Reference
    result
    PubMed Identifier
    10547176
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    28033164
    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.
    Results Reference
    result

    Learn more about this trial

    Biodex Sit2Stand for Individuals With Cardiac Disease

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