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Heart FailureNCT05647759

Rural HEART Camp Connect: A Feasibility Study

A study testing HEART Camp Connect in people with Heart Failure, run by University of Nebraska at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Heart Failure
What is being tested?
HEART Camp Connect
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
1 Jun 2022to 5 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of heart failure with preserved ejection fraction or heart failure (HF) with reduced ejection fraction (Stage C, chronic HF confirmed by echocardiography and clinical evaluation)
  • 19 years of age or older
  • Stable pharmacologic therapy per guidelines for preceding 30 days
  • Able to read and understand English.

Who cannot join

  • Clinical evidence of decompensated heart failure
  • Unstable angina
  • Myocardial infarction, coronary artery bypass surgery, or biventricular pacemaker less than 6 weeks prior
  • Orthopedic or neuromuscular disorders preventing participating in aerobic exercise
  • Pregnancy
  • Participation in 3 times per week aerobic exercise during the past 6 months
  • Plans to move more than 50 miles from the exercise facility in the next 12 weeks
  • Cardiopulmonary stress test results that preclude safe exercise training (arrhythmia) or cardiorespiratory fitness indicated by females with maximum oxygen consumption ≥ 21ml/kg/min and males with maximum oxygen consumption ≥ 24 ml/kg/min.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-5330

Other trials in United States

About this study

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.

Read the 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 ≥ 21ml/kg/min and males with oxygen consumption ≥ 24 ml/kg/min) 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 Activity/Exercise Diary. The Actigraph will be worn for 7 consecutive days at baseline, week 4, and week 8. Participants will be asked to record daily activity/exercise 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, he/she 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 he/she 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.

Conditions
Heart Failure
Being tested
HEART Camp Connect
Keywords
cardiac rehabilitation, exercise adherence, virtual coaching
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HEART Camp ConnectBehavioural

    Once eligible and enrolled, participants will aim to complete 150 minutes of moderate-intensity exercise a week with the help of a virtual exercise coach

Study groups in NCT05647759
Study groupRoleWhat they receive
HEART Camp ConnectExperimentalParticipants will have access to a virtual exercise platform or membership to a medical exercise facility. Participants will meet with a virtual exercise coach via zoom on a weekly basis.
Receives: Behavioral: HEART Camp Connect

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of administering Rural HEART Camp Connect

    Feasibility of administering an exercise intervention with the help of virtual exercise coaches to rural patients with heart failure including assessments of process, resources, and procedures as described below.

    Process Recruitment and retention monitoring, records of participant attendance at all sessions, monitor minutes coached for all HEART Camp participants

    Resources - staff availability, accessibility, staff training

    Procedures Identify connectivity issues, the number of potential participants without smart devices with optimal capacity for the HEART Camp Connect, and evaluating orientation to the Polar watch, rating of perceived exertion and digital diaries

    Data Management Ease of data collection including time to complete instruments, technological transfer of data, and patterns of missing data on an ongoing basis

    Measured: Baseline

  2. Determine perceptions of Rural HEART Camp connect in study participants

    Qualitative interviews will explore perceptions of all study procedures, including use of home-based exercise and virtual coaching.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2022
  2. Study start1 Jun 2022
  3. Primary completion16 Jan 2023
  4. Study completion5 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
This study is a prospective, single-group, repeated measures feasibility study.
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05647759
Sponsor's protocol ID
0773-20-FB
Status last verified
Sep 2023
First submitted
11 Nov 2022
Last updated
28 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing HEART Camp Connect in people with Heart Failure, run by University of Nebraska at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of administering Rural HEART Camp Connect (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.

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