Heart FailureEXT-HFNCT03648762
Exercise Therapy to Reduce Heart Failure Symptoms; Sorting Mechanisms of Benefit
A study testing Aerobic Exercise Intervention, Combined Aerobic and Strength Exercise Intervention and Inspiratory Muscle Training Exercise Intervention in people with Heart Failure, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
The purpose of this research study is to better understand how exercise training in older adults (≥65 years) with heart failure (HF) affects skeletal muscle both intrinsically and in respect to its impact on functional capacity. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Aerobic Exercise Intervention, Combined Aerobic and Strength Exercise Intervention and Inspiratory Muscle Training Exercise Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 May 2017to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Heart failure
- Echo in two years
- NYHA class II or III
- Optimal therapy according to AHA/ACC and HFSA HF guidelines; unless documented by a provider for variation.
Who cannot join
- Major cardiovascular event or procedure within the prior 6 weeks.
- Dementia
- Severe COPD (FEV1<50%),
- End-stage malignancy
- Severe valvular heart disease that would make exercise un safe
- Orthopedic limitation preventing exercise
Show all 14Show fewer
- Any bleeding disorder that would contraindicate safe exercise
- Women who are pregnant, breastfeeding, or likely to become pregnant within the next 6 months
- Psychiatric hospitalization within the last 3 months
- ICD device with heart rate limits that prohibit exercise assessments or exercise training.
- Referring physicians will be provided with an opportunity to reprogram devices so that patients can participate.
- Chronic use of oral corticosteroids or medications that affect muscle function.
- Notably, patients using statins will be eligible, and this will be factored into the randomization and analysis.
- Chronic ETOH or drug dependency shown within the last year
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
About this study
The purpose of this research study is to better understand how exercise training in older adults (≥65 years) with heart failure (HF) affects skeletal muscle both intrinsically and in respect to its impact on functional capacity. While many conceptualize HF as a pathophysiology that exclusively affects the heart, skeletal muscle atrophy and weakening are also elemental to the disease. While reduced exercise capacity is typically associated with HF, this may be related more to disease effects in skeletal muscle than the heart. This is a clinical study that focuses on exercise training which compares functional endpoints before and after training. Patients are randomized to one of three exercise training interventions (aerobic vs. aerobic and strength vs. inspiratory muscle training) for 12 weeks and are assessed pre- and post-training to determine if any differences occur in their skeletal muscle and functional capacity. Skeletal muscle biopsies before and after the exercise training intervention in order to study changes in skeletal muscle histology and biology.
Functional endpoints in this study include ventilatory gas indices from cardiopulmonary exercise testing, lower body strength testing, grip strength, sit-to-stand, six-minute-walk distance, gait speed, inspiratory muscle strength, and quality of life and physical activity-oriented questionnaires, including the Kansas City Cardiomyopathy Questionnaire, Duke Activity Status Index, and CHAMPS Physical Activity Questionnaire for Older Adults. Body composition is measured with Dual Energy X-ray (DXA) scanning. Skeletal muscle biopsies are completed in the vastus lateralis of the non-dominant leg to assess histology and biologic endpoints.
Read the detailed description
Despite decades of research, HF remains a common disease that continues to rise in prevalence, particularly among the expanding population of older adults. By virtue of age, older adults are prone to higher incidence of HF and worse clinical consequences. Exercise intolerance and dyspnea are common symptoms that portend poor prognosis, and which erode functional independence and quality of life. Mortality and morbidity also increase significantly as functional capacity declines.
Growing evidence suggests that pathophysiology of central cardiac dysfunction is linked to skeletal muscle pathophysiology. While HF therapeutic guidelines primarily emphasize steps that improve cardiac parameters, and/or volume status, goals to modify HF skeletal muscle myopathy may constitute a vital complementary treatment target.
Ongoing analyses from our pilot VA Merit investigation provide pertinent insights and substantiation. The investigators demonstrated reduced functional capacity (both aerobic and strength) in 31 HF patients (mean age 66 years) compared to 39 age-matched healthy controls (mean age 67). The investigators also showed increased expression of genes signaling ubiquitin-mediated proteolysis in skeletal muscle in relation to decreasing aerobic and strength performance. Consistently, reduced lean muscle mass, as measured by DXA, correlated to the reduced strength indices.
This proposal constitutes a logical progression of this pilot analysis and follows the analytic path the investigators anticipated. Whereas the initial work characterized key skeletal muscle gene expression patterns in association to disease, exercise capacity, and body composition, this study compares the effects of three exercise training regimens (i.e., aerobic vs. combined aerobic and strength vs. inspiratory muscle training [IMT]) each with a unique physiological rationale. The investigators will explore differences in how each training regimen modifies clinical attributes (function/symptoms) as well as skeletal muscle biology that likely underlie these differences. These insights will help identify therapeutic strategies that better suppress injurious disease mechanisms and thereby facilitate improved clinical outcomes and quality of life.
Specific Aims:
- To assess differences in functional outcomes (peak oxygen utilization [VO2]) and one-repetition max [1RM]) relative to different training regimens: a. Aerobic vs. Aerobic-Strength vs. inspiratory Muscle Training (IMT).
- Analyses will include assessments of training differences in respect to broader functional parameters (aerobic, strength, inspiration), symptoms, and quality of life.
- To assess gene expression in relation to the different training regimens.
- Conditions
- Heart Failure
- Being tested
- Aerobic Exercise Intervention, Combined Aerobic and Strength Exercise Intervention, Inspiratory Muscle Training Exercise Intervention
- Keywords
- Heart failure, Exercise, Cardiopulmonary
- Medical subject headings
- Heart Failure, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise InterventionBehavioural
Aerobic Exercise Intervention - 12 weeks of a minimum of 3 days a week for 60 minutes of aerobic exercise
Combined Aerobic and Strength Exercise InterventionBehavioural
Combined Aerobic and Strength Exercise Intervention- 12 weeks of a minimum of 3 days a week for 60 minutes of Combined Aerobic and Strength Exercise
Inspiratory Muscle Training Exercise InterventionBehavioural
Inspiratory Muscle Training Exercise Intervention- 12 weeks of a minimum of 3 days a week for 60 minutes of Inspiratory Muscle Training Exercise
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise Intervention | Other | 12 weeks of a minimum of 3 days a week for 60 minutes of aerobic exercise Receives: Behavioral: Aerobic Exercise Intervention |
| Combined Aerobic and Strength Exercise Intervention | Other | 12 weeks of a minimum of 3 days a week for 60 minutes of Combined Aerobic and Strength Exercise Receives: Behavioral: Combined Aerobic and Strength Exercise Intervention |
| Inspiratory Muscle Training Exercise Intervention | Other | 12 weeks of a minimum of 3 days a week for 60 minutes of Inspiratory Muscle Training Exercise Receives: Behavioral: Inspiratory Muscle Training Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen Uptake (VO2) Peak
a cardiopulmonary exercise test will be performed to determined peak VO2 in ML/KG/Min
Measured: baseline and through study completion an average of 14 weeks
One Repetition Maximum- Leg Press
Leg press will be performed on the Keiser Leg press and measured in kilograms (kg)
Measured: baseline and through study completion an average of 14 weeks
Secondary outcomes (5)
Metabolomics
Nitric Oxide Bioavailability (uM) Metabolomics
The scientific direction of our analyses for this measure has shifted over time. The investigators will pursue RNA seq and metabolomics to provide an unbiased path forward on viable targets in the muscle.
Measured: baseline and through study completion an average of 14 weeks
Skeletal Muscle Gene Expression
Skeletal muscle gene expression will be measured in RNA isolated from skeletal muscle biopsy samples via Illumina platform.
The measure "Number" indicates the number of differentially expressed genes, and units are fold change over baseline. To investigate how the lifestyle interventions impacted gene expression at the mRNA level in skeletal muscles of our research participants we performed high-throughput RNA-Sequencing (Illumina HiSeq paired-end 150 base pairs). Differential gene expression analysis was performed on the RNA-seq. data using DeSEQ2 to determine differentially expressed genes (DEGs) between groups. All DEG analyses were performed using the Wald test (p < 0.05) corrected for multiple comparisons using the Benjamini and Hochberg method.
Measured: baseline and through study completion an average of 14 weeks
Quality of Life and Daily Function Questionnaires
Participants completed the Kansas City Cardiomyopathy questionnaire (KCCQ) and Duke Activity Status (DASI) Index standardized questionnaires.
The KCCQ is scored on a scale of 0 to 100 with a higher score representing better health status.
DASI is a 12-item questionnaire that is scored on a scale of 0 to 58.2, with a higher score representing a higher functional status.
Measured: baseline and through study completion an average of 12 weeks
Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire for Older Adults - Frequency Component
Participants completed the Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire for Older Adults as part of the Quality of Life and Daily Function study outcome.
The CHAMPS questionnaire assesses duration and frequency of self-reported weekly physical activities of varying intensities in older adults.
One component of the CHAMPS score is the frequency per week (i.e. number or count of events per week) that the participant reported that they engaged in all exercise related activities, and the frequency per week that the participant engaged in moderate-vigorous activities.
The mean frequency of activities per week at baseline and follow-up for each study arm are reported here for the participants who completed both a baseline and follow-up assessment. A higher mean indicates a higher number of exercise-related activities were reported per week.
Measured: baseline and through study completion an average of 12 weeks
Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire for Older Adults - Duration Component
Participants completed the Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire for Older Adults as part of the Quality of Life and Daily Function study outcome.
The CHAMPS questionnaire assesses duration and frequency of self-reported weekly physical activities of varying intensities in older adults.
One component of the CHAMPS score is the self-reported duration in hours per week of all exercise-related activities, and duration in hours per week of moderate-vigorous exercise-related activities.
The mean duration of all exercise-related activities and moderate-vigorous activities in hours per week are reported here for participants in each study arm who completed both the baseline and 12 week follow-up assessments. A higher mean indicates that a longer duration of exercise-related activities in hours per week were reported.
Measured: baseline and through study completion an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start8 May 2017
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants with heart failure will complete 1 of 3 exercise training interventions (aerobic vs. aerobic and strength vs. inspiratory) for 12 weeks and will be assessed pre and post to determine if any differences occur in their skeletal muscle and functional capacity as part of the exercise intervention.
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Daniel E. Forman, MD, Principal investigator, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648762
- Sponsor's protocol ID
- O0834-R
- Acronym
- EXT-HF
- Status last verified
- Feb 2024
- First submitted
- 23 Aug 2018
- Last updated
- 24 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Therapy to Reduce Heart Failure Symptoms; Sorting Mechanisms of Benefit
- ClinicalTrials.gov ID
- NCT03648762
- Acronym / sponsor ID
- EXT-HF / O0834-R
- Conditions
- Heart Failure
- Keywords
- Heart failure, Exercise, Cardiopulmonary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 8 May 2017 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 27 Aug 2018 (actual)
- Results
- Posted 24 Jun 2024
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 research study is to better understand how exercise training in older adults (≥65 years) with heart failure (HF) affects skeletal muscle both intrinsically and in respect to its impact on functional capacity. While many conceptualize HF as a pathophysiology that exclusively affects the heart, skeletal muscle atrophy and weakening are also elemental to the disease. While reduced exercise capacity is typically associated with HF, this may be related more to disease effects in skeletal muscle than the heart. This is a clinical study that focuses on exercise training which compares functional endpoints before and after training. Patients are randomized to one of three exercise training interventions (aerobic vs. aerobic and strength vs. inspiratory muscle training) for 12 weeks and are assessed pre- and post-training to determine if any differences occur in their skeletal muscle and functional capacity. Skeletal muscle biopsies before and after the exercise training intervention in order to study changes in skeletal muscle histology and biology.
Functional endpoints in this study include ventilatory gas indices from cardiopulmonary exercise testing, lower body strength testing, grip strength, sit-to-stand, six-minute-walk distance, gait speed, inspiratory muscle strength, and quality of life and physical activity-oriented questionnaires, including the Kansas City Cardiomyopathy Questionnaire, Duke Activity Status Index, and CHAMPS Physical Activity Questionnaire for Older Adults. Body composition is measured with Dual Energy X-ray (DXA) scanning. Skeletal muscle biopsies are completed in the vastus lateralis of the non-dominant leg to assess histology and biologic endpoints.
Detailed description
Despite decades of research, HF remains a common disease that continues to rise in prevalence, particularly among the expanding population of older adults. By virtue of age, older adults are prone to higher incidence of HF and worse clinical consequences. Exercise intolerance and dyspnea are common symptoms that portend poor prognosis, and which erode functional independence and quality of life. Mortality and morbidity also increase significantly as functional capacity declines.
Growing evidence suggests that pathophysiology of central cardiac dysfunction is linked to skeletal muscle pathophysiology. While HF therapeutic guidelines primarily emphasize steps that improve cardiac parameters, and/or volume status, goals to modify HF skeletal muscle myopathy may constitute a vital complementary treatment target.
Ongoing analyses from our pilot VA Merit investigation provide pertinent insights and substantiation. The investigators demonstrated reduced functional capacity (both aerobic and strength) in 31 HF patients (mean age 66 years) compared to 39 age-matched healthy controls (mean age 67). The investigators also showed increased expression of genes signaling ubiquitin-mediated proteolysis in skeletal muscle in relation to decreasing aerobic and strength performance. Consistently, reduced lean muscle mass, as measured by DXA, correlated to the reduced strength indices.
This proposal constitutes a logical progression of this pilot analysis and follows the analytic path the investigators anticipated. Whereas the initial work characterized key skeletal muscle gene expression patterns in association to disease, exercise capacity, and body composition, this study compares the effects of three exercise training regimens (i.e., aerobic vs. combined aerobic and strength vs. inspiratory muscle training [IMT]) each with a unique physiological rationale. The investigators will explore differences in how each training regimen modifies clinical attributes (function/symptoms) as well as skeletal muscle biology that likely underlie these differences. These insights will help identify therapeutic strategies that better suppress injurious disease mechanisms and thereby facilitate improved clinical outcomes and quality of life.
Specific Aims:
- To assess differences in functional outcomes (peak oxygen utilization [VO2]) and one-repetition max [1RM]) relative to different training regimens: a. Aerobic vs. Aerobic-Strength vs. inspiratory Muscle Training (IMT).
- Analyses will include assessments of training differences in respect to broader functional parameters (aerobic, strength, inspiration), symptoms, and quality of life.
- To assess gene expression in relation to the different training regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants with heart failure will complete 1 of 3 exercise training interventions (aerobic vs. aerobic and strength vs. inspiratory) for 12 weeks and will be assessed pre and post to determine if any differences occur in their skeletal muscle and functional capacity as part of the exercise intervention.
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise Intervention | Other | Behavioral: Aerobic Exercise Intervention12 weeks of a minimum of 3 days a week for 60 minutes of aerobic exercise |
| Combined Aerobic and Strength Exercise Intervention | Other | Behavioral: Combined Aerobic and Strength Exercise Intervention12 weeks of a minimum of 3 days a week for 60 minutes of Combined Aerobic and Strength Exercise |
| Inspiratory Muscle Training Exercise Intervention | Other | Behavioral: Inspiratory Muscle Training Exercise Intervention12 weeks of a minimum of 3 days a week for 60 minutes of Inspiratory Muscle Training Exercise |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of Heart failure
- Echo in two years
- NYHA class II or III
- Optimal therapy according to AHA/ACC and HFSA HF guidelines; unless documented by a provider for variation.
Key exclusion criteria (14 listed)
- Major cardiovascular event or procedure within the prior 6 weeks.
- Dementia
- Severe COPD (FEV1<50%),
- End-stage malignancy
- Severe valvular heart disease that would make exercise un safe
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 |
|---|---|---|
| Aerobic Exercise InterventionAerobic Exercise Intervention - 12 weeks of a minimum of 3 days a week for 60 minutes of aerobic exercise | Behavioural | Aerobic Exercise Intervention |
| Combined Aerobic and Strength Exercise InterventionCombined Aerobic and Strength Exercise Intervention- 12 weeks of a minimum of 3 days a week for 60 minutes of Combined Aerobic and Strength Exercise | Behavioural | Combined Aerobic and Strength Exercise Intervention |
| Inspiratory Muscle Training Exercise InterventionInspiratory Muscle Training Exercise Intervention- 12 weeks of a minimum of 3 days a week for 60 minutes of Inspiratory Muscle Training Exercise | Behavioural | Inspiratory Muscle Training Exercise Intervention |
Primary outcome
Oxygen Uptake (VO2) Peak
Time frame: baseline and through study completion an average of 14 weeks
a cardiopulmonary exercise test will be performed to determined peak VO2 in ML/KG/Min
One Repetition Maximum- Leg Press
Time frame: baseline and through study completion an average of 14 weeks
Leg press will be performed on the Keiser Leg press and measured in kilograms (kg)
5 secondary outcomes
Metabolomics
Time frame: baseline and through study completion an average of 14 weeks
Skeletal Muscle Gene Expression
Time frame: baseline and through study completion an average of 14 weeks
Quality of Life and Daily Function Questionnaires
Time frame: baseline and through study completion an average of 12 weeks
Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire for Older Adults - Frequency Component
Time frame: baseline and through study completion an average of 12 weeks
Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire for Older Adults - Duration Component
Time frame: baseline and through study completion an average of 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Daniel E. Forman, MD principal investigator
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise Intervention, Combined Aerobic and Strength Exercise Intervention and Inspiratory Muscle Training Exercise Intervention in people with Heart Failure, run by VA Office of Research and Development at 2 sites 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 14 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 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 24 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Oxygen Uptake (VO2) Peak (time frame: baseline and through study completion an average of 14 weeks). 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 24 Jun 2024.