Heart FailureNCT02696486
Exercise Training Effect in Patients With HF and PEF
A study testing Exercise Training in people with Heart Failure, run by MultiCare Health System Research Institute at 1 site in United States.
Trial summary
The purpose of this is to develop and implement a pilot study that will demonstrate the ability to recruit, enroll, retain, conduct exercise training, and collect pre and post outcomes on the effect of exercise training on quality of life (QOL) and exercise capacity in patients with a diagnosis of heart failure with… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Jan 2017
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 55 years (Interested in capturing mean ages close to age 65 as many HF initiatives are based on this age group and HF development increases with aging).
- Diagnosis of HFPEF stable NYHA Stage II- III with an EF of ≥ 45%
- Stabilized on cardiac medications and post hospitalization > 4 weeks
- Ability to participate in exercise testing and training.
- Referral from Cardiologist or primary care physician.
Who cannot join
- Unstable Angina
- Uncontrolled diabetes
- Moderate to severe aortic stenosis
- Uncontrolled hypertension Systolic BP>150 mm Hg or Diastolic BP >100 mm Hg
- Valvular heart disease
- Untreated coronary artery stenosis >50%
Show all 11Show fewer
- Arrhythmias
- Pulmonary disease/COPD
- Dementia or cognitive impairment
- VAD or Transplant planned in next 6 months.
- Current or recent participation in a Cardiac Rehab program within the last six months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise Training Effect on Quality of Life and Exercise Capacity in Patients With Heart Failure and Preserved Ejection Fraction: A Pilot Study
The purpose of this is to develop and implement a pilot study that will demonstrate the ability to recruit, enroll, retain, conduct exercise training, and collect pre and post outcomes on the effect of exercise training on quality of life (QOL) and exercise capacity in patients with a diagnosis of heart failure with preserved ejection fraction (HFPEF).
- Conditions
- Heart Failure
- Being tested
- Exercise Training
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TrainingBehavioural
Study subjects will receive medically supervised aerobic and resistance exercise training for 1 hour per session, 3 times per week for 6 weeks at the Cardiac Rehab center and then transition to home or YMCA partnership based exercise with staff follow-up contact for an additional 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Training | Experimental | Not described Receives: Behavioral: Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life (QOL) score pre and post exercise training (ET).
Measured: 9 weeks
Secondary outcomes (3)
Change in exercise capacity/tolerance pre and post ET using Cardiopulmonary Exercise Testing.
Symptom limited treadmill testing with expired gas measurement and analysis. Exercise capacity measured as Peak Vo2 (peak exercise oxygen uptake) in ml/min/kg. Continuous monitoring of 12 lead electrocardiogram and blood pressure measured every 2 minutes. Peak Vo2 defined as highest Vo2 value of the last 30 seconds before termination of exercise. Exercise time and peak workload will be measured for exercise tolerance.
Measured: 9 weeks
Demonstrated ability to coordinate patient transition from clinic to home or YMCA partnership based exercise program with weekly staff follow-up within the study timeline.
Measured: 9 weeks
Capture 90 day hospital readmission data starting with study enrollment date and within the participants' study timeline.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study startNov 2015
- Primary completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- MultiCare Health System Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Henry Ford Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696486
- Sponsor's protocol ID
- 15.20
- Status last verified
- Jan 2017
- First submitted
- 22 Feb 2016
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Bean G, Mou J, Pflugeisen B, Olsen L, Hoag S, Silva A, Ball AL, Lee T. Exercise Training in Patients With Heart Failure With Preserved Ejection Fraction: A Community Hospital Pilot Study. J Cardiovasc Nurs. 2021 Mar-Apr 01;36(2):124-130. doi: 10.1097/JCN.0000000000000737.
PubMed 32740221
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Training Effect on Quality of Life and Exercise Capacity in Patients With Heart Failure and Preserved Ejection Fraction: A Pilot Study
- ClinicalTrials.gov ID
- NCT02696486
- Acronym / sponsor ID
- 15.20
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- MultiCare Health System Research InstituteUniversity, hospital or other
- Collaborators
- Henry Ford Hospital
- Study start
- Nov 2015
- Primary completion
- Jan 2017 (actual)
- First posted
- 2 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this is to develop and implement a pilot study that will demonstrate the ability to recruit, enroll, retain, conduct exercise training, and collect pre and post outcomes on the effect of exercise training on quality of life (QOL) and exercise capacity in patients with a diagnosis of heart failure with preserved ejection fraction (HFPEF).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Training | Experimental | Behavioral: Exercise Training |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 55 years (Interested in capturing mean ages close to age 65 as many HF initiatives are based on this age group and HF development increases with aging).
- Diagnosis of HFPEF stable NYHA Stage II- III with an EF of ≥ 45%
- Stabilized on cardiac medications and post hospitalization > 4 weeks
- Ability to participate in exercise testing and training.
- Referral from Cardiologist or primary care physician.
Key exclusion criteria (11 listed)
- Unstable Angina
- Uncontrolled diabetes
- Moderate to severe aortic stenosis
- Uncontrolled hypertension Systolic BP>150 mm Hg or Diastolic BP >100 mm Hg
- Valvular heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise TrainingStudy subjects will receive medically supervised aerobic and resistance exercise training for 1 hour per session, 3 times per week for 6 weeks at the Cardiac Rehab center and then transition to home or YMCA partnership based exercise with staff follow-up contact for an additional 3 weeks. | Behavioural | Exercise Training |
Primary outcome
Change in Quality of Life (QOL) score pre and post exercise training (ET).
Time frame: 9 weeks
3 secondary outcomes
Change in exercise capacity/tolerance pre and post ET using Cardiopulmonary Exercise Testing.
Time frame: 9 weeks
Demonstrated ability to coordinate patient transition from clinic to home or YMCA partnership based exercise program with weekly staff follow-up within the study timeline.
Time frame: 9 weeks
Capture 90 day hospital readmission data starting with study enrollment date and within the participants' study timeline.
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
- Derived from this study: PubMed 32740221Bean G, Mou J, Pflugeisen B, Olsen L, Hoag S, Silva A, Ball AL, Lee T. Exercise Training in Patients With Heart Failure With Preserved Ejection Fraction: A Community Hospital Pilot Study. J Cardiovasc Nurs. 2021 Mar-Apr 01;36(2):124-130. doi: 10.1097/JCN.0000000000000737.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Training in people with Heart Failure, run by MultiCare Health System Research Institute 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 5 inclusion and 11 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 10 Jan 2017. 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?
Change in Quality of Life (QOL) score pre and post exercise training (ET). (time frame: 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02696486, which also lists 1 linked publication.
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 10 Jan 2017.