Heart Failure Preserved Ejection FractionNCT02435667
Resistance Training in HFpEF
A study testing Resistance Exercise Training, DEXA bone scan and Cardiopulmonary Max Exercise Test in people with Heart Failure Preserved Ejection Fraction, run by Mayo Clinic at 1 site in United States.
Trial summary
The objective of this proposal is to determine the effect of resistance exercise training on locomotor muscle function, exercise capacity, exertional symptoms, and quality of life in HF patients with preserved ejection fraction (HFpEF). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure Preserved Ejection Fraction
- What is being tested?
- Resistance Exercise Training, DEXA bone scan and Cardiopulmonary Max Exercise Test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jan 2021
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of HFpEF.
- Patients 18-80 yrs old with a history stable (no medication changes in past 6 weeks (w/duration of diagnosis >6 months).
- New York Heart Association class I-III.
- Ejection fraction ≥40%.
- Current non-smokers with <15 pack year history.
- Non-pregnant women, and individuals who are able to exercise (i.e. without orthopedic limitations or neuromuscular disorders).
Who cannot join
- Patient refusal to participate.
- Significant orthopedic or neuromuscular limitations
- Significant cognitive impairment
- Hemoglobin < 7.0 g/d.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Resistance Exercise Training in Heart Failure With Preserved Ejection Fraction (Resist - HFpEF)
The objective of this proposal is to determine the effect of resistance exercise training on locomotor muscle function, exercise capacity, exertional symptoms, and quality of life in HF patients with preserved ejection fraction (HFpEF).
Read the detailed description
In this randomized controlled pilot study of resistance exercise training in patients with HFpEF, the investigators will recruit 24 HFpEF patients who will be randomized to resistance exercise training (RT - n=12) or no resistance exercise training (standard care control group [CTL] - n=12). The investigators will have baseline and follow-up measures of clinical characteristics, leg muscle strength, quality of life, lean muscle mass (body composition via DXA including segmental lean mass), maximal cardiopulmonary exercise test (peak VO2, peak work, ventilatory efficiency), constant-load submaximal cardiopulmonary exercise test with speckle tracking echocardiography (exertional dyspnea and fatigue at matched workloads, cardiac output, diastolic function, left ventricular strain, ventilation, gas exchange, and locomotor muscle neural feedback).
Participants will be asked to make 4 separate study visits. Those randomized to undergo Resistance Training will be expected to make those visits as well.
- Being tested
- Resistance Exercise Training, DEXA bone scan, Cardiopulmonary Max Exercise Test, Quality of Life Questionnaire, Submaximal Exercise Test
- Keywords
- Resistance Training, Exercise, Heart Failure preserved Ejection Fraction
- Medical subject headings
- Heart Failure, Diastolic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance Exercise TrainingOther
- Aerobic Exercise
- Each participant will engage in 5 minutes of aerobic based exercise on an arm/leg ergometer (NuStep Cross Trainer) at an intensity of 12-14 on the Borg Rating of Perceived Exertion Scale as a warm-up prior to the exercise session and again as a cool-down at the end of the exercise session.
- Resistance Exercise - 2 sets of 8-12 repetitions - beginning at 60% of the initial 1 RM.
- Leg Extension, b) Bicep Curl, c) Leg Press, d) Chest Press, e) Leg Curl, f)Seated Row (horizontal or pulldown), g) Calf Raises
- Core Strengthening Exercises a. 5-10 minutes of stability ball and balance exercises
DEXA bone scanRadiation
A DEXA scan that provides bone density measures.
Cardiopulmonary Max Exercise TestOther
Pedaling on a cycle ergometer to volitional fatigue.
Quality of Life QuestionnaireOther
A 10 minute questionnaire that measures quality of life.
Submaximal Exercise TestOther
Two short submaximal constant-load exercise sessions at 20 Watts. Each session will include 6 minutes of cycling (baseline). Following baseline, the sessions will be randomized to continued constant-load cycling for an additional 9 minutes (for echocardiographic measures) or randomized sub-systolic inflation of bilateral thigh pressure tourniquets to 40 and 80 mmHg for 3 minutes with 3 minutes of deflation between inflations to stimulate locomotor muscle neural feedback.
Blood DrawOther
A blood draw amounting to 1 teaspoon of blood drawn.
| Study group | Role | What they receive |
|---|---|---|
| Resistance Exercise Training | Experimental | Entails 36 supervised resistance exercise training sessions (3 sessions per week for 12 weeks). Each exercise session will be supervised by a trained, certified Exercise Physiologist specializing in Cardiac Rehabilitation. The specific resistance exercise training will include Aerobic Exercise, Resistance Exercise, and Core Strengthening Exercises. Other baseline and follow-up tests include: DEXA bone scan, Blood Draw, Cardiopulmonary Max Exercise Test, Quality of Life Questionnaire, and a Submaximal Exercise Test. Receives: Other: Resistance Exercise Training; Radiation: DEXA bone scan; Other: Cardiopulmonary Max Exercise Test; Other: Quality of Life Questionnaire; Other: Submaximal Exercise Test; Other: Blood Draw |
| Standard Care | Placebo comparator | No resistance exercise training. Patients will stay on their current healthcare regimen as previously assigned by their physician. Patients will still undergo baseline and follow-up tests similar to the Resistance Exercise Training group, including: DEXA bone scan, Blood Draw, Cardiopulmonary Max Exercise Test, Quality of Life Questionnaire, and a Submaximal Exercise Test. Receives: Radiation: DEXA bone scan; Other: Cardiopulmonary Max Exercise Test; Other: Quality of Life Questionnaire; Other: Submaximal Exercise Test; Other: Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone density and strength
DEXA scan
Measured: 12 weeks
Cardiopulmonary Function
Cardiopulmonary bike exercise
Measured: 12 weeks
Quality of Life
Questionnaire
Measured: 12 weeks
Blood Biomarkers
Blood draw
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2021
- Study completionJan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas P. Olson, M.S., Ph.D., Mayo Clinic
- Investigators
- Thomas Olson, MS, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435667
- Sponsor's protocol ID
- 15-000320
- Status last verified
- Feb 2021
- First submitted
- 29 Apr 2015
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance Exercise Training in Heart Failure With Preserved Ejection Fraction (Resist - HFpEF)
- ClinicalTrials.gov ID
- NCT02435667
- Acronym / sponsor ID
- 15-000320
- Keywords
- Resistance Training, Exercise, Heart Failure preserved Ejection Fraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Jan 2021 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 6 May 2015 (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 objective of this proposal is to determine the effect of resistance exercise training on locomotor muscle function, exercise capacity, exertional symptoms, and quality of life in HF patients with preserved ejection fraction (HFpEF).
Detailed description
In this randomized controlled pilot study of resistance exercise training in patients with HFpEF, the investigators will recruit 24 HFpEF patients who will be randomized to resistance exercise training (RT - n=12) or no resistance exercise training (standard care control group [CTL] - n=12). The investigators will have baseline and follow-up measures of clinical characteristics, leg muscle strength, quality of life, lean muscle mass (body composition via DXA including segmental lean mass), maximal cardiopulmonary exercise test (peak VO2, peak work, ventilatory efficiency), constant-load submaximal cardiopulmonary exercise test with speckle tracking echocardiography (exertional dyspnea and fatigue at matched workloads, cardiac output, diastolic function, left ventricular strain, ventilation, gas exchange, and locomotor muscle neural feedback).
Participants will be asked to make 4 separate study visits. Those randomized to undergo Resistance Training will be expected to make those visits as well.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance Exercise Training | Experimental | Other: Resistance Exercise Training, Radiation: DEXA bone scan, Other: Cardiopulmonary Max Exercise Test, Other: Quality of Life Questionnaire, Other: Submaximal Exercise Test, Other: Blood DrawEntails 36 supervised resistance exercise training sessions (3 sessions per week for 12 weeks). Each exercise session will be supervised by a trained, certified Exercise Physiologist specializing in Cardiac Rehabilitation. The specific resistance exercise training will include Aerobic Exercise, Resistance Exercise, and Core Strengthening Exercises. Other baseline and follow-up tests include: DEXA bone scan, Blood Draw, Cardiopulmonary Max Exercise Test, Quality of Life Questionnaire, and a Submaximal Exercise Test. |
| Standard Care | Placebo comparator | Radiation: DEXA bone scan, Other: Cardiopulmonary Max Exercise Test, Other: Quality of Life Questionnaire, Other: Submaximal Exercise Test, Other: Blood DrawNo resistance exercise training. Patients will stay on their current healthcare regimen as previously assigned by their physician. Patients will still undergo baseline and follow-up tests similar to the Resistance Exercise Training group, including: DEXA bone scan, Blood Draw, Cardiopulmonary Max Exercise Test, Quality of Life Questionnaire, and a Submaximal Exercise Test. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of HFpEF.
- Patients 18-80 yrs old with a history stable (no medication changes in past 6 weeks (w/duration of diagnosis >6 months).
- New York Heart Association class I-III.
- Ejection fraction ≥40%.
- Current non-smokers with <15 pack year history.
Key exclusion criteria (4 listed)
- Patient refusal to participate.
- Significant orthopedic or neuromuscular limitations
- Significant cognitive impairment
- Hemoglobin < 7.0 g/d.
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 |
|---|---|---|
| Resistance Exercise Training1. Aerobic Exercise a. Each participant will engage in 5 minutes of aerobic based exercise on an arm/leg ergometer (NuStep Cross Trainer) at an intensity of 12-14 on the Borg Rating of Perceived Exertion Scale as a warm-up prior to the exercise session and again as a cool-down at the end of the exercise session. 2. Resistance Exercise - 2 sets of 8-12 repetitions - beginning at 60% of the initial 1 RM. a) Leg Extension, b) Bicep Curl, c) Leg Press, d) Chest Press, e) Leg Curl, f)Seated Row (horizontal or pulldown), g) Calf Raises 3. Core Strengthening Exercises a. 5-10 minutes of stability ball and balance exercises | Other | Resistance Exercise Training |
| DEXA bone scanA DEXA scan that provides bone density measures. | Radiation | Resistance Exercise Training, Standard Care |
| Cardiopulmonary Max Exercise TestPedaling on a cycle ergometer to volitional fatigue. | Other | Resistance Exercise Training, Standard Care |
| Quality of Life QuestionnaireA 10 minute questionnaire that measures quality of life. | Other | Resistance Exercise Training, Standard Care |
| Submaximal Exercise TestTwo short submaximal constant-load exercise sessions at 20 Watts. Each session will include 6 minutes of cycling (baseline). Following baseline, the sessions will be randomized to continued constant-load cycling for an additional 9 minutes (for echocardiographic measures) or randomized sub-systolic inflation of bilateral thigh pressure tourniquets to 40 and 80 mmHg for 3 minutes with 3 minutes of deflation between inflations to stimulate locomotor muscle neural feedback. | Other | Resistance Exercise Training, Standard Care |
| Blood DrawA blood draw amounting to 1 teaspoon of blood drawn. | Other | Resistance Exercise Training, Standard Care |
Primary outcome
Bone density and strength
Time frame: 12 weeks
DEXA scan
Cardiopulmonary Function
Time frame: 12 weeks
Cardiopulmonary bike exercise
Quality of Life
Time frame: 12 weeks
Questionnaire
Blood Biomarkers
Time frame: 12 weeks
Blood draw
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 3 Feb 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Thomas Olson, MS, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Exercise Training, DEXA bone scan and Cardiopulmonary Max Exercise Test in people with Heart Failure Preserved Ejection Fraction, run by Mayo Clinic 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 6 inclusion and 4 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 3 Feb 2021. 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. Some participants in this study may receive a placebo. 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?
Bone density and strength (time frame: 12 weeks). The study lists 4 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 3 Feb 2021.