Ignite Creation Date:
2024-05-06 @ 6:47 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05784753
Status:
RECRUITING
Last Update Posted:
2024-02-01
First Post:
2023-03-02
Brief Title:
HEART Camp Connect -Promoting Exercise in Adults With Heart Failure With Preserved Ejection Fraction
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
Official Title:
HEART Heart Failure Exercise and Resistance Training Camp Connect Promoting Adherence to Exercise in Adults With Heart Failure With Preserved Ejection Fraction
Status:
RECRUITING
Status Verified Date:
2024-09
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:
The goal of this clinical trial is to learn more about patients with heart failure with preserved ejection fraction HFpEF and exercise Investigators want to see if meeting with a coach in person or by videoconference will help these patients exercise feel better and change markers in their blood Participants will be randomly placed in one of three groups for 18 months All groups will have access to a fitness center and be given a watch and heart rate monitor to wear during exercise The usual care group control group will have access to exercise videos via the medical fitness center and will not meet with a coach The HEART Camp group will exercise and meet with their coach in-person at the medical fitness center The HEART Camp Connect group will have access to exercise videos via the medical fitness center and will meet with their coach via videoconferencing All participants will take part in an exercise test and study training prior to being randomized At four data collection time points participants will wear an activity monitor for 7 days each have their blood drawn and answer questions related to heart failure and exercise Participants will also wear a heart rate monitor when they exercise and fill out a daily exercise diary
Detailed Description:
The overall objectives for this study are to a test the efficacy of virtual and in-person exercise interventions to promote long-term adherence to exercise b determine a benchmark of exercise minutes that reaches a minimal clinically important difference in heart failure related health status and drives improvements in physical function inflammatory markers and patient-reported outcomes c identify interventional mechanisms interim clinical events and prognostic indicators of heart failure with preserved ejection fraction HFpEF that mediate adherence d assess delivery method and related cost of the intervention to support translation and scalability To meet these objectives investigators propose a three-group 2-2-1 randomized repeated measures experimental design with 4 data collection points baseline 6 12 and 18 months to compare HEART Camp HEART Camp Connect and virtual enhanced usual care EUC
This study begins with the cardiopulmonary exercise testing CPET The CPET is used to develop an exercise prescription and ensure participant safety and readiness for exercise Participants who have completed a CPET within 6 months of enrollment with no changes in medications will not repeat the test Any participants who exhibit potential safety concerns during CPET eg cardiac arrhythmias balance instability will be evaluated by a trained providers prior to continuing in the study Those deemed unsafe to exercise will be withdrawn After the CPET participants will take part in the run-in period with 3 monitored sessions in cardiac rehabilitation and study orientation All participants will be oriented during a one-time in-person training to familiarize them with the 1 Either in-person Engage center or Engage virtual platform via the HEART Camp You Tube channel 2 All monitoring devices Polar watch and Polar heart rate monitor Actigraph rating of perceived exertion scale and exercise diary and 3 Private HEART Camp You Tube channel where they can view investigator-developed educational videos specific to HFpEF and virtual exercise content Participants who do not have a smart device with internet capability or have an insufficient data plan will be given a tablet with a wireless data plan for study use
After randomization participants in the intervention groups HEART Camp Connect and HEART Camp meet with a coach for the first 12 months of the study The HEART Camp group will meet in-person at the medical fitness center with their coach The HEART Camp Connect group will meet virtually over videoconference To improve the scalability of this intervention investigators will taper coaching sessions according to the following schedule Months 1-3 weekly 1-on-1 coaching for 30 minutes Months 4-12 1-on-1 coaching is reduced to 15 minute sessions every other week On alternate weeks participants will attend a 1-hour group-based exercise training and coaching During these sessions the coach will meet with 4-6 participants at once One half of the class will be an exercise training session and the other half will be a questionanswer session for participants to talk to the coach and each other about strategies for exercise After 12 months coaching both intervention groups and motivational messages HEART Camp Connect only will stop and participants will be expected to self-regulate exercise in months 13-18
Participants will be asked to build up to 150 minutes of moderate-intensity exercise weekly During exercise sessions participants will be asked to wear their study-provided watch and heart rate monitor and keep a daily exercise diary
Participants will meet with research personnel at 4 times during the study for data collection including where they will have their blood drawn and complete a 6 minute walk test At these data collection time points participants will also wear an activity monitor for 7 daysnights and complete surveys related to their heart failure and exercise
This study begins with the cardiopulmonary exercise testing CPET The CPET is used to develop an exercise prescription and ensure participant safety and readiness for exercise Participants who have completed a CPET within 6 months of enrollment with no changes in medications will not repeat the test Any participants who exhibit potential safety concerns during CPET eg cardiac arrhythmias balance instability will be evaluated by a trained providers prior to continuing in the study Those deemed unsafe to exercise will be withdrawn After the CPET participants will take part in the run-in period with 3 monitored sessions in cardiac rehabilitation and study orientation All participants will be oriented during a one-time in-person training to familiarize them with the 1 Either in-person Engage center or Engage virtual platform via the HEART Camp You Tube channel 2 All monitoring devices Polar watch and Polar heart rate monitor Actigraph rating of perceived exertion scale and exercise diary and 3 Private HEART Camp You Tube channel where they can view investigator-developed educational videos specific to HFpEF and virtual exercise content Participants who do not have a smart device with internet capability or have an insufficient data plan will be given a tablet with a wireless data plan for study use
After randomization participants in the intervention groups HEART Camp Connect and HEART Camp meet with a coach for the first 12 months of the study The HEART Camp group will meet in-person at the medical fitness center with their coach The HEART Camp Connect group will meet virtually over videoconference To improve the scalability of this intervention investigators will taper coaching sessions according to the following schedule Months 1-3 weekly 1-on-1 coaching for 30 minutes Months 4-12 1-on-1 coaching is reduced to 15 minute sessions every other week On alternate weeks participants will attend a 1-hour group-based exercise training and coaching During these sessions the coach will meet with 4-6 participants at once One half of the class will be an exercise training session and the other half will be a questionanswer session for participants to talk to the coach and each other about strategies for exercise After 12 months coaching both intervention groups and motivational messages HEART Camp Connect only will stop and participants will be expected to self-regulate exercise in months 13-18
Participants will be asked to build up to 150 minutes of moderate-intensity exercise weekly During exercise sessions participants will be asked to wear their study-provided watch and heart rate monitor and keep a daily exercise diary
Participants will meet with research personnel at 4 times during the study for data collection including where they will have their blood drawn and complete a 6 minute walk test At these data collection time points participants will also wear an activity monitor for 7 daysnights and complete surveys related to their heart failure and exercise
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