SarcopeniaDARTNCT03978572
Dual-benefits of Aerobic and Resistance Training
A study testing Resistance Training, Moderate-Intensity Continuous Cycling and High-Intensity Interval Cycling in people with Sarcopenia and Aging, run by Ohio University at 1 site in United States.
Trial summary
This study evaluates the effect of three different exercise strategies on physical function in older adults. Participants will be randomly assigned to one of three exercise groups: resistance training, moderate-intensity continuous cycling on a stationary bicycle, and high-intensity interval training on a stationary… Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Aging, Disability Physical
- What is being tested?
- Resistance Training, Moderate-Intensity Continuous Cycling and High-Intensity Interval Cycling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 30 Sep 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 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 60-75 years with no significant health issues or conditions that, in the investigator's opinion, would limit the subject's ability to complete the study per protocol or that would impact the capability to get an accurate measurement of study endpoints.
- Body mass index between 18.0 and 35 kg/m2.
- Willingness to maintain current diet and adhere to the intervention programs described for the study and willing to undergo all testing procedures.
- Able to read, understand, and complete study-related questionnaires
- Able to read and understand, and willing to sign the informed consent form (ICF).
- 6-minute walk distance of 450-725 meters for men and 400-675 meters for women.
Who cannot join
- Failure to provide informed consent.
- 6-minute walk distance below 450 meters or above 725 meters for men, below 400 meters or above 675 meters for women
- Any activities of daily living (ADL) disability (difficulty feeding, dressing, continence, bathing, toileting, and transferring).
- Lives in a nursing home or assisted living facility
- Known neuromuscular or neurological conditions affecting somatosensory or motor function or control (e.g., hemiplegia, multiple sclerosis, peripheral neuropathy, Parkinsons disease, Myasthenia Gravis, Ataxia, Apraxia, post-polio syndrome, mitochondrial myopathy, etc.).
- Unable to communicate because of severe hearing loss or speech disorder.
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- Severe visual impairment, which would preclude completion of the assessments.
- Cancer requiring treatment currently or in the past 2 years (except primary non-melanoma skin cancer or in situ cervical cancer)
- Hospitalization (medical confinement for 24 hours), or immobilization, or major surgical procedure requiring general anesthesia within 12 weeks prior to screening, or any planned surgical procedures during the study period.
- Chronic or relapsing/remitting gastrointestinal disorders such as inflammatory bowel disease and irritable bowel syndrome.
- Known history of human immunodeficiency virus (HIV) antibody at screening.
- Use of systemic glucocorticoids.
- Any history of angina pectoris
- Any history of heart failure
- Any history of myocardial infarction
- Any coronary artery bypass graft or percutaneous coronary intervention
- Heart disease that limits exercise (valvular, congenital, ischaemic and hypertrophic cardiomyopathy)
- Complex ventricular arrhythmias or heart block
- Chronic obstructive pulmonary disease, cerebrovascular disease, or peripheral vascular disease
- Diabetes mellitus
- Severe neuropathy
- Mini-mental state exam score (MMSE) below 19
- Psychiatric conditions that warrant acute or chronic therapeutic intervention (e.g., major depressive disorder, bipolar disorder, panic disorder, schizophrenia) that in the investigators opinion may interfere with the conduct of study procedures
- Unable to undergo magnetic resonance imaging (MRI) (e. g. body containing any metallic medical devices or equipment, including heart pacemakers, metal prostheses, implants or surgical clips, any prior injury from shrapnel or grinding metal, exposure to metallic dusts, metallic shavings or having tattoos containing metallic dyes).
- Unable to reliably undergo exercise or strength tests described for this study.
- Participation in progressive resistance exercise 2 or more days/week for most weeks over the 24 weeks prior to screening, OR 150+ minutes of accumulated aerobic exercise each week for most weeks over the 24 weeks prior to screening.
- Current self-reported activity level that, in the investigator's opinion, is considered highly active for older adults
- Participation in any clinical trial within 12 weeks prior to screening.
- Limb amputation (except for toes) and/or any fracture within 24 weeks.
- Any disorder that will not allow completion of the motions required for resistance or aerobic exercise
- Conditions (such as myasthenia gravis, myositis, muscular dystrophy or myopathy, including drug-induced myopathy) leading to muscle loss, muscle weakness, muscle cramps or myalgia.
- Acute viral or bacterial upper or lower respiratory infection at screening
- Abnormal or uncontrolled blood pressure (BP) at the screening visit defined as BP > 170/100 mmHg. If taking anti-hypertensive medication, have to be on stable doses of medication for more than 3 months.
- Current or recent history (within 1 year of screen) of heavy alcohol consumption or drug abuse that in the investigators opinion may interfere with the conduct of study procedures.
- Reports being pregnant, lactating, or that they anticipate becoming pregnant in the next 3-months. If a woman becomes pregnant while on study protocol they will be withdrawn from the study
- Prohibited Medications: Medications that, in the PIs opinion, would confound study integrity by interacting with study outcomes. For instance:
- Anti-obesity drugs, nutraceuticals, and dietary supplements that may affect body mass and body composition.
- Any drug or supplement known to influence muscle mass or performance including but not limited to anabolic steroids, insulin-like growth factor 1 (IGF-1), growth hormone (GH), replacement androgen therapy, anti-androgen therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The DART Study: Exercise Strategies to Improve Physical Function in Older Adults
This study evaluates the effect of three different exercise strategies on physical function in older adults. Participants will be randomly assigned to one of three exercise groups: resistance training, moderate-intensity continuous cycling on a stationary bicycle, and high-intensity interval training on a stationary bicycle.
Read the detailed description
This project is confronting age-related physical disability by optimizing exercise strategies for older adults. Aerobic training is recommended to improve cardiorespiratory (heart and lung) function, while strength training is recommended for muscular function. These exercise effects are necessary for building healthier lives and reducing mortality and disability risk, but most older adults who do exercise typically only perform one type of exercise. In doing so they are missing a key component for healthy aging. This study will address whether stationary-cycling high-intensity interval training results in both cardiorespiratory and muscular improvements, and it will be the first controlled study comparing adaptations to high-intensity interval, aerobic, and strength training in sedentary older adults.
It is unclear whether the lack of muscular adaptations to traditional aerobic training is due to the low intensity/high volume model that is currently prescribed, and thus the central hypothesize of the study is that stationary-cycling high-intensity interval training can improve both cardiorespiratory and muscular function. To test this hypothesis, the investigators will measure heart, lung, and muscle function, as well as physical performance in sedentary older adults, before and after 12 weeks of supervised training using one of three exercise strategies; stationary-cycling high-intensity interval training, stationary-cycling moderate-intensity continuous training, or strength training. By comparing the outcomes across these three groups, the investigators will be able to confirm if short intervals of high-intensity exercise can elicit both cardiorespiratory and muscular benefits.
This work will demonstrate that older adults can improve their cardiovascular health and muscular strength with a single exercise strategy. Establishing in detail the cardiovascular and muscular benefits of this exercise can lead to the implementation of new and improved exercise guidelines for cardiovascular health and reduced physical disability in older adults. Incidentally, it will also provide a framework for future studies to investigate the importance of intensity in exercise. At the end of this study the investigators will be able to disseminate a new evidence-based exercise protocol that will address a significant barrier to healthy aging.
- Conditions
- Sarcopenia, Aging, Disability Physical
- Being tested
- Resistance Training, Moderate-Intensity Continuous Cycling, High-Intensity Interval Cycling
- Keywords
- Exercise
- Medical subject headings
- Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance TrainingBehavioural
Exercise intervention designed to improve muscular strength and power
Moderate-Intensity Continuous CyclingBehavioural
Exercise intervention designed to improve cardiorespiratory fitness and muscular endurance
High-Intensity Interval CyclingBehavioural
Exercise intervention designed to improve cardiorespiratory fitness, muscular endurance, and muscular strength and power
| Study group | Role | What they receive |
|---|---|---|
| Resistance Training | Active comparator | 12 weeks of whole-body progressive resistance training, three days per week, lower-extremity focused (60% of exercises targeting lower extremities) Receives: Behavioral: Resistance Training |
| Moderate-intensity continuous cycling | Active comparator | 12 weeks of progressive endurance cycling on a stationary bicycle at a target heart rate, three days per week. Receives: Behavioral: Moderate-Intensity Continuous Cycling |
| High-intensity interval cycling | Experimental | 12 weeks of progressive high-intensity interval cycling on a stationary bicycle, three days per week. Receives: Behavioral: High-Intensity Interval Cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Oxygen Consumption
The primary endpoint is maximal oxygen consumption measured by both relative and absolute changes in maximal oxygen consumption obtained during a graded exercise test on a cycle ergometer.
Measured: Change from baseline at 12 weeks
Knee extensor isokinetic power
Maximal muscle power (maximal torque in foot-pounds) of the quadriceps using an isokinetic dynamometer
Measured: Change from baseline at 12 weeks
Secondary outcomes (2)
Knee extensor isometric force production
Maximal muscle strength of the quadriceps (in foot-pounds) as measured by an isometric dynamometer
Measured: Change from baseline at 12 weeks
Knee extensor isokinetic endurance
Total power output (cumulative torque in foot-pounds) produced from 120 consecutive maximal knee extensions using an isokinetic dynamometer
Measured: Change from baseline at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start1 Feb 2019
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Why it stopped: Temporarily paused due to COVID-19 and expected to resume. Not of IRB approval
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 SarcopeniaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Brian C Clark, PhD, Study chair, Ohio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978572
- Sponsor's protocol ID
- 18-F-55
- Acronym
- DART
- Status last verified
- Sep 2020
- First submitted
- 3 Jun 2019
- Last updated
- 16 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tavoian D, Russ DW, Law TD, Simon JE, Chase PJ, Guseman EH, Clark BC. A Randomized Clinical Trial Comparing Three Different Exercise Strategies for Optimizing Aerobic Capacity and Skeletal Muscle Performance in Older Adults: Protocol for the DART Study. Front Med (Lausanne). 2019 Oct 22;6:236. doi: 10.3389/fmed.2019.00236. eCollection 2019.
PubMed 31750307
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The DART Study: Exercise Strategies to Improve Physical Function in Older Adults
- ClinicalTrials.gov ID
- NCT03978572
- Acronym / sponsor ID
- DART / 18-F-55
- Conditions
- Sarcopenia, Aging, Disability Physical
- Keywords
- Exercise
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Temporarily paused due to COVID-19 and expected to resume. Not of IRB approval
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 7 Jun 2019 (actual)
- 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.
This study evaluates the effect of three different exercise strategies on physical function in older adults. Participants will be randomly assigned to one of three exercise groups: resistance training, moderate-intensity continuous cycling on a stationary bicycle, and high-intensity interval training on a stationary bicycle.
Detailed description
This project is confronting age-related physical disability by optimizing exercise strategies for older adults. Aerobic training is recommended to improve cardiorespiratory (heart and lung) function, while strength training is recommended for muscular function. These exercise effects are necessary for building healthier lives and reducing mortality and disability risk, but most older adults who do exercise typically only perform one type of exercise. In doing so they are missing a key component for healthy aging. This study will address whether stationary-cycling high-intensity interval training results in both cardiorespiratory and muscular improvements, and it will be the first controlled study comparing adaptations to high-intensity interval, aerobic, and strength training in sedentary older adults.
It is unclear whether the lack of muscular adaptations to traditional aerobic training is due to the low intensity/high volume model that is currently prescribed, and thus the central hypothesize of the study is that stationary-cycling high-intensity interval training can improve both cardiorespiratory and muscular function. To test this hypothesis, the investigators will measure heart, lung, and muscle function, as well as physical performance in sedentary older adults, before and after 12 weeks of supervised training using one of three exercise strategies; stationary-cycling high-intensity interval training, stationary-cycling moderate-intensity continuous training, or strength training. By comparing the outcomes across these three groups, the investigators will be able to confirm if short intervals of high-intensity exercise can elicit both cardiorespiratory and muscular benefits.
This work will demonstrate that older adults can improve their cardiovascular health and muscular strength with a single exercise strategy. Establishing in detail the cardiovascular and muscular benefits of this exercise can lead to the implementation of new and improved exercise guidelines for cardiovascular health and reduced physical disability in older adults. Incidentally, it will also provide a framework for future studies to investigate the importance of intensity in exercise. At the end of this study the investigators will be able to disseminate a new evidence-based exercise protocol that will address a significant barrier to healthy aging.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Resistance Training | Active comparator | Behavioral: Resistance Training12 weeks of whole-body progressive resistance training, three days per week, lower-extremity focused (60% of exercises targeting lower extremities) |
| Moderate-intensity continuous cycling | Active comparator | Behavioral: Moderate-Intensity Continuous Cycling12 weeks of progressive endurance cycling on a stationary bicycle at a target heart rate, three days per week. |
| High-intensity interval cycling | Experimental | Behavioral: High-Intensity Interval Cycling12 weeks of progressive high-intensity interval cycling on a stationary bicycle, three days per week. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 60-75 years with no significant health issues or conditions that, in the investigator's opinion, would limit the subject's ability to complete the study per protocol or that would impact the capability to get an accurate measurement of study endpoints.
- Body mass index between 18.0 and 35 kg/m2.
- Willingness to maintain current diet and adhere to the intervention programs described for the study and willing to undergo all testing procedures.
- Able to read, understand, and complete study-related questionnaires
- Able to read and understand, and willing to sign the informed consent form (ICF).
Key exclusion criteria (38 listed)
- Failure to provide informed consent.
- 6-minute walk distance below 450 meters or above 725 meters for men, below 400 meters or above 675 meters for women
- Any activities of daily living (ADL) disability (difficulty feeding, dressing, continence, bathing, toileting, and transferring).
- Lives in a nursing home or assisted living facility
- Known neuromuscular or neurological conditions affecting somatosensory or motor function or control (e.g., hemiplegia, multiple sclerosis, peripheral neuropathy, Parkinsons disease, Myasthenia Gravis, Ataxia, Apraxia, post-polio syndrome, mitochondrial myopathy, etc.).
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 TrainingExercise intervention designed to improve muscular strength and power | Behavioural | Resistance Training |
| Moderate-Intensity Continuous CyclingExercise intervention designed to improve cardiorespiratory fitness and muscular endurance | Behavioural | Moderate-intensity continuous cycling |
| High-Intensity Interval CyclingExercise intervention designed to improve cardiorespiratory fitness, muscular endurance, and muscular strength and power | Behavioural | High-intensity interval cycling |
Primary outcome
Maximal Oxygen Consumption
Time frame: Change from baseline at 12 weeks
The primary endpoint is maximal oxygen consumption measured by both relative and absolute changes in maximal oxygen consumption obtained during a graded exercise test on a cycle ergometer.
Knee extensor isokinetic power
Time frame: Change from baseline at 12 weeks
Maximal muscle power (maximal torque in foot-pounds) of the quadriceps using an isokinetic dynamometer
2 secondary outcomes
Knee extensor isometric force production
Time frame: Change from baseline at 12 weeks
Knee extensor isokinetic endurance
Time frame: Change from baseline at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Derived from this study: PubMed 31750307Tavoian D, Russ DW, Law TD, Simon JE, Chase PJ, Guseman EH, Clark BC. A Randomized Clinical Trial Comparing Three Different Exercise Strategies for Optimizing Aerobic Capacity and Skeletal Muscle Performance in Older Adults: Protocol for the DART Study. Front Med (Lausanne). 2019 Oct 22;6:236. doi: 10.3389/fmed.2019.00236. eCollection 2019.
- 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.
Brian C Clark, PhD study chair
Ohio University
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 Training, Moderate-Intensity Continuous Cycling and High-Intensity Interval Cycling in people with Sarcopenia and Aging, run by Ohio University 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 38 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: paused, as of the sponsor's last update on 16 Sep 2020. 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?
Results are not available in the source record.
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?
Maximal Oxygen Consumption (time frame: Change from baseline at 12 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?
On the ClinicalTrials.gov record for NCT03978572, 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 16 Sep 2020.