NCT01771900

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 subject's 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Apr 2005

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2007

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2012

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 18, 2013

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

2.7 years

First QC Date

June 15, 2012

Last Update Submit

August 29, 2023

Conditions

Heart Failure

Keywords

heart failureexerciseadherence to exercise

Outcome Measures

Primary Outcomes (3)

  • Adherence to Exercise

    Change in adherence to exercise as recorded in digital diary

    Baseline to 3 months

  • Change in Self-efficacy to exercise

    Measured with the Cardiac Exercise Self-Efficacy Instrument

    Baseline to three months

  • Change in Estimated energy expenditure

    Measured with the RT3 Accelerometer

    Baseline to three months

Secondary Outcomes (4)

  • Change in Symptoms

    Baseline to three months

  • Change in Biomarkers

    Baseline to three months

  • Change in Physical and psychological functioning

    Baseline to three months

  • Heart failure symptoms impact on physical and social function and quality of life

    Baseline to three months

Study Arms (2)

Heart Camp Group

EXPERIMENTAL

In Week 1, 2, and 3 subjects will attend the HEART CAMP. Subjects will set specific exercise goals. Subjects will be taught how to record exercise data on the computer at the exercise facility. Specific activities will teach subjects aerobic and resistance training exercises and build self-efficacy to exercise. During the period from month 3 to the end of study subjects will continue the training program independently and no formal sessions will be scheduled.

Behavioral: Heart Camp Group

Attention Control Group

EXPERIMENTAL

Subjects will receive a 60 minute group session led by a specifically designated control group intervention nurse. Phone calls will be placed to the subject if they miss a Friday group session and attendance to meetings will be encouraged.

Behavioral: Attention Control Group

Interventions

Heart Camp GroupBEHAVIORAL

In Week 1, 2, and 3 subjects will attend the HEART CAMP. Subjects will set specific exercise goals. Subjects will be taught how to record exercise data on the computer at the exercise facility. Specific activities will teach subjects aerobic and resistance training exercises and build self-efficacy to exercise. During the period from month 3 to the end of study subjects will continue the training program independently and no formal sessions will be scheduled.

Heart Camp Group
Attention Control GroupBEHAVIORAL

Subjects will receive a 60 minute group session led by a specifically designated control group intervention nurse. Phone calls will be placed to the subject if they miss a Friday group session and attendance to meetings will be encouraged.

Attention Control Group

Eligibility Criteria

Age19 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or greater
  • Oriented to person, place, time
  • Able to speak and read English
  • Resting left ventricular ejection fraction of 40% of less
  • Optimum stable medical therapy for past 30 days

You may not qualify if:

  • Clinical evidence of decompensated HF
  • Unstable angina pectoris
  • Myocardial infarction, coronary artery bypass surgery or biventricular pacemaker less than 3 months ago
  • Orthopedic or neuromuscular disorders preventing participation in exercise and strength/resistance training
  • Participation in 3 times per week aerobic exercise during the past 12 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BryanLGH Heart Institute

Lincoln, Nebraska, 68506, United States

Location

Related Publications (3)

  • Pozehl B, Duncan K, Hertzog M, Norman JF. Heart Failure Exercise And Training Camp: effects of a multicomponent exercise training intervention in patients with heart failure. Heart Lung. 2010 Nov-Dec;39(6 Suppl):S1-13. doi: 10.1016/j.hrtlng.2010.04.008. Epub 2010 Jul 3.

    PMID: 20598373RESULT

  • Norman JF, Pozehl BJ, Duncan KA, Hertzog MA, Elokda AS, Krueger SK. Relationship of resting B-type natriuretic peptide level to cardiac work and total physical work capacity in heart failure patients. J Cardiopulm Rehabil Prev. 2009 Sep-Oct;29(5):310-3. doi: 10.1097/HCR.0b013e3181ac7bcb.

    PMID: 19561522RESULT

  • Duncan K, Pozehl B, Norman JF, Hertzog M. A self-directed adherence management program for patients with heart failure completing combined aerobic and resistance exercise training. Appl Nurs Res. 2011 Nov;24(4):207-14. doi: 10.1016/j.apnr.2009.08.003. Epub 2009 Oct 15.

    PMID: 22099469RESULT

MeSH Terms

Conditions

Heart FailureMotor Activity

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Bunny Pozehl, PhD, APRN-NP

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2012

First Posted

January 18, 2013

Study Start

April 1, 2005

Primary Completion

December 26, 2007

Study Completion

December 26, 2007

Last Updated

September 1, 2023

Record last verified: 2023-08

Locations

US(1)