Ignite Creation Date:
2024-05-06 @ 1:17 AM
Last Modification Date:
2024-10-26 @ 11:01 AM
Study NCT ID:
NCT01771900
Status:
COMPLETED
Last Update Posted:
2023-09-01
First Post:
2012-06-15
Brief Title:
Heart Failure Exercise And Resistance Training Camp HEART Camp
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
Official Title:
Heart Failure Exercise and Resistance Training CAMP
Status:
COMPLETED
Status Verified Date:
2023-08
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:
HEART
Brief Summary:
The purpose of this feasibility study was to obtain pilot data as the basis for a future larger investigation testing the impact of an innovative training camp intervention called HEART CAMP Heart failure Exercise And Resistance Training CAMP to teach HF patients how to exercise and self-manage exercise behavior over time The study assessed the feasibility and adequacy of the intervention the data collection plan and the reliability and sensitivity of the outcome measures The 6-month intervention was based on a training camp model to teach HF patients how to exercise in a fun group-oriented atmosphere Subjects interacted and exercised in small groups with an exercise physiologist and nurse to guide activities The dosage of the intervention frequency and amount of direct guidance from the exercise physiologist and nurse decreased over the 6 months in order to increase subjects independence and promote long-term adherence to exercise The intervention incorporated use of computerized data files to monitor exercise behavior compare exercise performance to individualized goals and provide feedback as strategies to foster adherence and self-management of exercise behavior
Detailed Description:
This study uses an experimental repeated measures design with randomized comparison of the HEART CAMP intervention group and the attention control group The purpose of this feasibility study is to obtain pilot data as the basis for a future larger investigation testing the impact of an innovative 24-week 6-month training camp intervention HEART CAMP HEART CAMP is designed to teach heart failure HF patients how to exercise aerobic and resistance and self-manage exercise behavior over time Patients receiving care at the BryanLGH Heart Institute heart failure clinic will be eligible for the study
The HEART CAMP intervention is a multi-component intervention derived from Banduras cognitive behavioral theory and consists of specific strategies to build self-efficacy for exercise The subject under the guidance of an exercise physiologist and nurse will be taught how to exercise aerobic and resistance A baseline cardiopulmonary exercise test will be completed on all subjects The first three weeks of HEART CAMP will be held in a hospital based cardiac rehabilitation department where subjects will be electrocardiographically monitored during the five-day per week training sessions Training sessions will be delivered in cohort groups of eight subjects and will focus on exercise self-evaluation of response to exercise and group debriefing sessions for problem solving and relapse management Weeks 4 through 12 subjects will complete three aerobic exercise sessions in the cardiac rehabilitation maintenance facility and two resistive training sessions at home with the exercise physiologist and nurse monitoring subject response and delivering group debriefing sessions each week Weeks 12 through 24 subjects exercise independently with the exercise physiologist and nurse monitoring subject exercise data and available as needed
The attention control group will receive weekly cohort group education sessions during the first 3 months similar to the intervention groups participation in weekly group sessions One week an educational topic will be presented and the subsequent week the cohort group of eight subjects will discuss the topic Six topics will be presented including Eating Fruits Vegetables and Grains Shopping Wisely Cooking Healthy Time Management Communicating Assertively and Learning to Relax
Outcome measures will be completed at baseline 3 weeks 3 and 6 months end of study for both groups Primary outcomes are estimated energy expenditure self-efficacy to exercise and adherence to exercise Secondary outcomes are symptoms biomarker BNP physical and psychological functioning and quality of life
The HEART CAMP intervention is a multi-component intervention derived from Banduras cognitive behavioral theory and consists of specific strategies to build self-efficacy for exercise The subject under the guidance of an exercise physiologist and nurse will be taught how to exercise aerobic and resistance A baseline cardiopulmonary exercise test will be completed on all subjects The first three weeks of HEART CAMP will be held in a hospital based cardiac rehabilitation department where subjects will be electrocardiographically monitored during the five-day per week training sessions Training sessions will be delivered in cohort groups of eight subjects and will focus on exercise self-evaluation of response to exercise and group debriefing sessions for problem solving and relapse management Weeks 4 through 12 subjects will complete three aerobic exercise sessions in the cardiac rehabilitation maintenance facility and two resistive training sessions at home with the exercise physiologist and nurse monitoring subject response and delivering group debriefing sessions each week Weeks 12 through 24 subjects exercise independently with the exercise physiologist and nurse monitoring subject exercise data and available as needed
The attention control group will receive weekly cohort group education sessions during the first 3 months similar to the intervention groups participation in weekly group sessions One week an educational topic will be presented and the subsequent week the cohort group of eight subjects will discuss the topic Six topics will be presented including Eating Fruits Vegetables and Grains Shopping Wisely Cooking Healthy Time Management Communicating Assertively and Learning to Relax
Outcome measures will be completed at baseline 3 weeks 3 and 6 months end of study for both groups Primary outcomes are estimated energy expenditure self-efficacy to exercise and adherence to exercise Secondary outcomes are symptoms biomarker BNP physical and psychological functioning and quality of life
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R15NR009215-01 | NIH | None | httpsreporternihgovquickSearch1R15NR009215-01 |