Coronary Artery DiseaseNCT03170011
Biodex Sit2Stand for Individuals With Cardiac Disease
A study testing Exercise using the Biodex Sit2Stand Trainer in people with Coronary Artery Disease and Frail Elderly Syndrome, run by St. Ambrose University.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Coronary Artery Disease, Frail Elderly Syndrome, Heart Failure
- What is being tested?
- Exercise using the Biodex Sit2Stand Trainer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2017to 15 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not meeting inclusion criteria
About this study
Official title: 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.
Read the 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.
- Being tested
- Exercise using the Biodex Sit2Stand Trainer
- Keywords
- Cardiac rehabilitation, Sit to Stand, Function
- Medical subject headings
- Coronary Artery Disease, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise using the Biodex Sit2Stand TrainerBehavioural
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Exercise using the Biodex Sit2Stand Trainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Short Physical Performance Battery
Lower extremity functional assessment tool which include gait speed, sit to stand ability and static balance
Measured: Week 0 and Week 7
Secondary outcomes (5)
Change in Isometric knee extension strength
Measured in 90 degrees of flexion with hand held dynamometer
Measured: Week 0 and Week 7
Change in 10 meter gait speed
Self selected walking speed over 10 meters
Measured: Week 0 and Week 7
Change in Six Minute Walk Test
Total distance ambulated during a 6 minute time period.
Measured: Week 0 and Week 7
Change in HeartQoL
Quality of Life assessment tool
Measured: Week 0 and Week 7
Change in MacNew
Quality of life assessment tool
Measured: Week 0 and Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start1 Jun 2017 (estimated)
- Primary completion15 Sep 2017 (estimated)
- Study completion15 Sep 2017 (estimated)
Why it stopped: Unable to enroll any participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Ambrose University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Puthoff, St. Ambrose University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170011
- Sponsor's protocol ID
- 1
- Status last verified
- Sep 2019
- First submitted
- 14 May 2017
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 3787784Stevenson 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.
PubMed 19935142Zullo 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.
PubMed 20068420Goel 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.
PubMed 20551829Ades 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.
PubMed 10547176Puthoff 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.
PubMed 28033164
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of the Biodex Sit2Stand Trainer on Function for Individuals With Cardiac Disease
- ClinicalTrials.gov ID
- NCT03170011
- Acronym / sponsor ID
- 1
- Keywords
- Cardiac rehabilitation, Sit to Stand, Function
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to enroll any participants.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Ambrose UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (estimated)
- Primary completion
- 15 Sep 2017 (estimated)
- Study completion
- 15 Sep 2017 (estimated)
- First posted
- 30 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This cohort design study will examine the effects of a six week training program using the Biodex Sit2Stand Trainer.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Exercise using the Biodex Sit2Stand TrainerThe 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- Not meeting inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise using the Biodex Sit2Stand TrainerAlso: Biodex Sit2Stand TrainerWeek 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 | Behavioural | Intervention |
Primary outcome
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
5 secondary outcomes
Change in Isometric knee extension strength
Time frame: Week 0 and Week 7
Change in 10 meter gait speed
Time frame: Week 0 and Week 7
Change in Six Minute Walk Test
Time frame: Week 0 and Week 7
Change in HeartQoL
Time frame: Week 0 and Week 7
Change in MacNew
Time frame: Week 0 and Week 7
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Results publication: PubMed 3787784Jensen 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 publication: PubMed 19935142Stevenson 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 publication: PubMed 20068420Zullo 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 publication: PubMed 20551829Goel 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 publication: PubMed 10547176Ades 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 publication: PubMed 28033164Puthoff 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.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
Recruiting
Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
Coronary Artery Disease, High Risk Percutaneous Coronary Intervention
Active, not recruitingObservational study
Post-Induction Low Cardiac Output Syndrome in Coronary Artery Bypass Graft Surgery
Cardiac Output, Low, Coronary Arterial Disease
RecruitingPhase 3
A Clinical Trial To Investigate The Effect Of EA-230 On Hospital Length Of Stay In Patients With Coronary Artery Disease (CAD) Undergoing Coronary Artery Bypass Grafting (CABG) Surgery.
Coronary Artery Disease (CAD), Coronary Artery Bypass Graft Surgery(CABG)
Enrolling by invitationObservational study
Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW Study
Non-obstructive Coronary Disease, Acute or Chronic Coronary Artery Disease
Recruiting
Aggressive Lipid Lowering Therapy in ICI-Treated Melanoma
Melanoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise using the Biodex Sit2Stand Trainer in people with Coronary Artery Disease and Frail Elderly Syndrome, run by St. Ambrose University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Short Physical Performance Battery (time frame: Week 0 and Week 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03170011, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.