Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06576297
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-02-22
Brief Title:
Novel Respiratory Training as Part of Palliative Care for Older Adults With Heart Failure
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Novel Respiratory Training as Part of Palliative Care for Older Adults With Heart Failure
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RETRO
Brief Summary:
In a randomized controlled trial to study the utility of inspiratory muscle training IMT to improve functional outcomes in adults aged 70 years with heart failure HF who have been referred to palliative care for end-stage HF management
The study team hypothesize that older HF patients will be able to use IMT safely reliably and effectively in a 12-week home-based training regimen
The study team hypothesize that physical function sit to stand gait speed grip strength respiratorypulmonary function self-efficacy fatigue and quality of life will increase among older HF patients randomized IMT versus those randomized to usual care
The study team hypothesize that older HF patients will be able to use IMT safely reliably and effectively in a 12-week home-based training regimen
The study team hypothesize that physical function sit to stand gait speed grip strength respiratorypulmonary function self-efficacy fatigue and quality of life will increase among older HF patients randomized IMT versus those randomized to usual care
Detailed Description:
Heart failure both HF with reduced ejection fraction HFrEF and HF with preserved ejection fraction HFpEF are on the rise in our aging population Exercise intolerance is a leading detriment of the disease While it is understood that exercise training is beneficial strategies to achieve exercise training in this population are inherently limited particularly as the issues that contribute to HF pathophysiology ie advanced age frailty multimorbidity also predispose to sedentariness weakening frailty sarcopenia fatigue and cognitive impairment Physical activity and particularly exercise training may be hard to initiate and sustain especially because it is encumbered by limitations Home-based exercise training strategies are conceptually appealing in respect to practicality of access but the associated issues of monitoring for effective and safe exercise motivation and tracking of training are all difficult to achieve in a home-based format Furthermore many older adults lack suitable space or resources for traditional home-based exercise training
IMT with the PrO2 device responds to these challenges with a novel approach to achieve physiologically robust training effect strength training of the diaphragm in a way that mitigates breathlessness and augments multiple indices of function in a way that is practical and safe even at home The electronic dimensions of the device also enable embedded trackability and behavioral prompts Overall this is a novel approach to a common familiar problem and it responds directly to a well-known problem of dyspnea sedentariness and related functional decline that undermines current standards of HF care
Existing models of exercise training for HF rely primarily on site-based regimens of aerobic and strength training modalities Implementation barriers include unfeasible logistics for patients who often do not drive particularly as many older patients struggle with frailty as well as limitations due to cognitive decline sensory impairment andor socioeconomic challenges amidst the predictable complexities associated with advanced age Fear and poor motivation compound these limitations with limited options to motivate supervise and track progress for many candidates
This proposal promotes the concept of Palliative Care Rehab which is transformational in concept It shifts the premise of cardiac rehabilitation from cardiorespiratory fitness to more rudimentary goals of activities of daily living and self-efficacy Likewise rather than focusing on traditional cardiovascular endpoints of exercise testing and high performance this study is oriented to submaximal endpoints fatigability and qualitative metrics
IMT with the PrO2 device responds to these challenges with a novel approach to achieve physiologically robust training effect strength training of the diaphragm in a way that mitigates breathlessness and augments multiple indices of function in a way that is practical and safe even at home The electronic dimensions of the device also enable embedded trackability and behavioral prompts Overall this is a novel approach to a common familiar problem and it responds directly to a well-known problem of dyspnea sedentariness and related functional decline that undermines current standards of HF care
Existing models of exercise training for HF rely primarily on site-based regimens of aerobic and strength training modalities Implementation barriers include unfeasible logistics for patients who often do not drive particularly as many older patients struggle with frailty as well as limitations due to cognitive decline sensory impairment andor socioeconomic challenges amidst the predictable complexities associated with advanced age Fear and poor motivation compound these limitations with limited options to motivate supervise and track progress for many candidates
This proposal promotes the concept of Palliative Care Rehab which is transformational in concept It shifts the premise of cardiac rehabilitation from cardiorespiratory fitness to more rudimentary goals of activities of daily living and self-efficacy Likewise rather than focusing on traditional cardiovascular endpoints of exercise testing and high performance this study is oriented to submaximal endpoints fatigability and qualitative metrics
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None