Ignite Creation Date:
2024-05-06 @ 6:23 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05647759
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2022-11-11
Brief Title:
Rural HEART Camp Connect A Feasibility Study
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
Official Title:
Rural HEART Camp Connect A Feasibility Study
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study builds on the tested and refined HEART Camp intervention which has been shown to improve long-term adherence to exercise in individuals diagnosed with heart failure HEART Camp Connect enhances HEART Camp by delivering the coaching via videoconference and providing access to hospital-based exercise facilities and online exercise programming This study is a prospective single-group repeated measures feasibility study with 4 data collection points baseline 4 8 and 12 weeks Study variables including instruments will be collected at baseline 4 and 8 weeks Participants will also be asked to participate in a 30-45 minute interview at 12 weeks
Detailed Description:
At a rural health center in central Nebraska potential participants will be identified screened and approached for participation Study personnel will obtain informed consent in person in a private room or over the phone facilitated by the University of Nebraska Medical Center UNMC electronic consent process Once consented participants will complete cardiopulmonary exercise testing CPET to guide individual exercise prescriptions and protect against risks associated with exercise CPET results that preclude safe exercise training arrhythmia or those with CPET results indicating cardio-respiratory fitness females with maximum oxygen consumption 21mlkgmin and males with oxygen consumption 24 mlkgmin will be withdrawn from the study
Study personnel will complete baseline data collection demographics survey collection and 6-minute-walk-test on all participants at enrollment The survey instruments have been validated and will be repeated at weeks 4 and 8 Participants will be given instruction on the use of the Actigraph Polar Watch and chest strap and ActivityExercise Diary The Actigraph will be worn for 7 consecutive days at baseline week 4 and week 8 Participants will be asked to record daily activityexercise in their diary for the entirety of the 12-week study and will be shared weekly with their coach Participants will wear their Polar Watch and chest strap during exercise sessions for heart rate monitoring
Prior to beginning exercise on their own participants will complete 6 supervised monitored sessions in cardiac rehabilitation During these sessions participants will be monitored by cardiac rehabilitation staff for adverse events during moderate-intensity aerobic exercise 40-80 of heart rate reserve and resistance training 10-15 repetitions to volitional fatigue During these sessions participants will also receive educational training via videos on topics such as exercising with heart failure how medications impact exercise and nutrition If a participant does not complete the sessions or is deemed unsafe to exercise heshe will not be eligible to continue in the study
Participants will be instructed to wear a heart rate monitor Polar Watch and chest strap during all exercise sessions and strive to meet a goal of 150 minutes of moderate-intensity exercise per week Minutes toward adherence goals for the study will be calculated as time spent participating in a moderate-intensity activity and determined by their CPET results and personalized exercise prescription Participants will be familiar with using heart rate and Rating of Perceived Exertion RPE to guide their exercise from their participation in the 6 supervised sessions The heart rate monitor will be blue-tooth enabled and will require connection to the internet
Participants will be given the choice to exercise at a hospital-based exercise facility at home or as a hybrid approach If exercising at home participants will be provided with training plans that will be available online or in hard-copy forms
Each participant will be given access to an Omaha-based exercise coach that heshe will meet with weekly over Zoom for 30 minutes Coaches will discuss exercise over the past week including problems issues concerns Goals will be set reviewed assessed and revised each week
All participants will be given paid access to a hospital-based fitness facility for 8 weeks out of this 12-week study Weeks 9-12 of the study participants may elect to self-pay for membership or exercise at home Exercise diaries will continue to be collected and Polar watch data will be monitored by exercise coaches until the end of this 12-week study Participants will not meet with their exercise coach during the final 4 weeks The rationale for this is that ultimately our goal is for participants to develop self-efficacy knowledge and positive attitudes toward exercise that will allow them to adhere to exercise without our intervention The hope is that 8 weeks of exercise training and weekly coaching will get them started and they will continue on their own after that
Study personnel will complete baseline data collection demographics survey collection and 6-minute-walk-test on all participants at enrollment The survey instruments have been validated and will be repeated at weeks 4 and 8 Participants will be given instruction on the use of the Actigraph Polar Watch and chest strap and ActivityExercise Diary The Actigraph will be worn for 7 consecutive days at baseline week 4 and week 8 Participants will be asked to record daily activityexercise in their diary for the entirety of the 12-week study and will be shared weekly with their coach Participants will wear their Polar Watch and chest strap during exercise sessions for heart rate monitoring
Prior to beginning exercise on their own participants will complete 6 supervised monitored sessions in cardiac rehabilitation During these sessions participants will be monitored by cardiac rehabilitation staff for adverse events during moderate-intensity aerobic exercise 40-80 of heart rate reserve and resistance training 10-15 repetitions to volitional fatigue During these sessions participants will also receive educational training via videos on topics such as exercising with heart failure how medications impact exercise and nutrition If a participant does not complete the sessions or is deemed unsafe to exercise heshe will not be eligible to continue in the study
Participants will be instructed to wear a heart rate monitor Polar Watch and chest strap during all exercise sessions and strive to meet a goal of 150 minutes of moderate-intensity exercise per week Minutes toward adherence goals for the study will be calculated as time spent participating in a moderate-intensity activity and determined by their CPET results and personalized exercise prescription Participants will be familiar with using heart rate and Rating of Perceived Exertion RPE to guide their exercise from their participation in the 6 supervised sessions The heart rate monitor will be blue-tooth enabled and will require connection to the internet
Participants will be given the choice to exercise at a hospital-based exercise facility at home or as a hybrid approach If exercising at home participants will be provided with training plans that will be available online or in hard-copy forms
Each participant will be given access to an Omaha-based exercise coach that heshe will meet with weekly over Zoom for 30 minutes Coaches will discuss exercise over the past week including problems issues concerns Goals will be set reviewed assessed and revised each week
All participants will be given paid access to a hospital-based fitness facility for 8 weeks out of this 12-week study Weeks 9-12 of the study participants may elect to self-pay for membership or exercise at home Exercise diaries will continue to be collected and Polar watch data will be monitored by exercise coaches until the end of this 12-week study Participants will not meet with their exercise coach during the final 4 weeks The rationale for this is that ultimately our goal is for participants to develop self-efficacy knowledge and positive attitudes toward exercise that will allow them to adhere to exercise without our intervention The hope is that 8 weeks of exercise training and weekly coaching will get them started and they will continue on their own after that
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None