AgingNCT02505529
The UNCODE Study: Unravelling the Neural Contributors Of Dynapenia in Elders
A study testing Resistance Exercise Training and Mental Imagery in people with Aging, run by Ohio University at 1 site in United States.
Trial summary
The UNCODE Study seeks to better identify the neurological causes of muscle weakness associated with advancing age. The main study consists of 4 laboratory-based testing sessions that involve testing muscle strength and physical and cognitive function as well as a battery of tests to 1) quantify brain excitability… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Resistance Exercise Training and Mental Imagery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Dec 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 60+ 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 16.0 and 40.0 kg/m2.
- With no condition that would limit participation in supervised resistance training exercise based on the Physical Activity Readiness Questionnaire (PAR-Q) (for the "Resistance Exercise Training Sub-Study only).
- Willingness to maintain current diet and adhere to the intervention programs described for the sub-studies (if applicable) 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).
Who cannot join
- Failure to provide informed consent.
- Any activity of daily living (ADL) disability (difficulty feeding, dressing, continence, bathing, toileting, and transferring).
- Lives in a nursing home; persons living in assisted or independent housing will not be excluded.
- Cognitive impairment, defined as a known diagnosis of dementia or Modified Mini-Mental State exam score <24
- Known neuromuscular or neurological conditions affecting somatosensory or motor function or control (e.g., hemiplegia, multiple sclerosis, peripheral neuropathy, Parkinson's disease, Myasthenia Gravis, Ataxia, Apraxia, post-polio syndrome, mitochondrial myopathy, etc.).
- Unable to communicate because of severe hearing loss or speech disorder.
Show all 31Show fewer
- 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.
- Severe pulmonary disease, requiring either steroid pills or injections or the use of supplemental oxygen.
- Severe cardiac disease, including New York Heart Association (NYHA) Class III or IV congestive heart failure, clinically significant aortic stenosis, recent history of cardiac arrest (within 6-months), use of a cardiac defibrillator, or uncontrolled angina.
- Renal failure on hemodialysis
- 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 MRI or transcranial magnetic stimulation (TMS) (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 within the previous 24 weeks prior to screening (for sub-studies only).
- Participation in any clinical trial within 12 weeks prior to screening (for sub-studies only).
- Limb amputation (except for toes) and/or any fracture within 24 weeks.
- Osteoarthritis, rheumatologic diseases or orthopedic disorders that will not allow completion of the motions required for the resistance exercise (for Resistance Exercise Training Sub-Study only).
- 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 at the screening visit defined as diastolic BP >100 and/or systolic BP >170 mm Hg; if taking anti-hypertensive medication, have to be on stable doses of medication for more than 3 months.
- Medications known to alter the investigators' primary TMS-based outcomes. For instance, individuals taking benzodiazepines will be excluded from study participation.
- 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.
- Subjects with the following abnormal ECG findings at screening will be excluded: Electrocardiogram findings indicative of left ventricular hypertrophy (LVH) (based on Cornell voltage criteria):
- For men: S in V3 plus R in a VL >2.8 milliVolts (mV) (28 mm)
- For women: S in V3 plus R in a VL >2.0 mV (20 mm)
- Electrocardiogram finding of QT prolongation
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio Musculoskeletal and Neurological Institute (OMNI) at Ohio University
Athens, Ohio, 45701
About this study
Official title: Neural Mechanisms of Dynapenia
The UNCODE Study seeks to better identify the neurological causes of muscle weakness associated with advancing age. The main study consists of 4 laboratory-based testing sessions that involve testing muscle strength and physical and cognitive function as well as a battery of tests to 1) quantify brain excitability (using non-invasive transcranial magnetic stimulation), 2) modulate brain excitability (using non-invasive transcranial direct current stimulation), 3) spinal motor nerve firing characteristics, and 4) brain structure and function characteristics based on magnetic resonance images of the brain. Additionally, three option sub-studies are also available for enrollment. The first is a genetics sub-study where a cheek swab will be used to examine associations between certain genes and the physiological and functional measures obtained from the main study. The other two sub-studies are interventions. The first sub-study is a progressive resistance exercise training study where study participants will undergo 12-weeks of exercise training (3x/wk) and at the completion of the exercise training the measures obtained in the main study will be re-assessed. The other sub-study is a mental imagery sub-study where subjects are randomly assigned to perform a mental imagery training program consisting of imaging strong muscle contractions and mobility tasks (5x/wk) or to serve as a control (i.e., to not modify lifestyle) for 6-weeks. At the completion of the respective intervention period the measures obtained in the main study will be re-assessed.
Read the detailed description
The UNCODE Study seeks to better identify the neurological causes of muscle weakness associated with advancing age. The main study consists of 4 laboratory-based testing sessions that involve testing muscle strength and physical and cognitive function as well as a battery of tests to 1) quantify brain excitability (using single and paired pulse transcranial magnetic stimulation of the upper and lower extremity muscles), 2) modulate brain excitability of the upper extremity muscles (using non-invasive transcranial direct current stimulation), 3) spinal motor nerve firing characteristics using decomposition surface electromyography, and 4) brain structure and function characteristics based on magnetic resonance images of the brain. Additionally, three optional sub-studies are also available for enrollment. The first is a genetics sub-study where a cheek swab will be used to examine associations between certain genes (APOE-4 allele) and the physiological and functional measures obtained from the main study. The other two sub-studies are interventions. The first sub-study is a progressive resistance exercise training study where study participants will undergo 12-weeks of exercise training (3x/wk) and at the completion of the exercise training the measures obtained in the main study will be re-assessed. The other sub-study is a mental imagery sub-study where subjects are randomly assigned to perform a mental imagery training program consisting of imaging strong muscle contractions and mobility tasks (5x/wk) or to serve as a control (i.e., to not modify lifestyle) for 6-weeks. At the completion of the respective intervention period the measures obtained in the main study will be re-assessed.
- Conditions
- Aging
- Being tested
- Resistance Exercise Training, Mental Imagery
- Keywords
- Aging, Muscle, Weakness, Sarcopenia, Dynapenia
- Medical subject headings
- Asthenia, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance Exercise TrainingOther
Behavioral interventions of resistance exercise
Mental ImageryOther
Behavioral intervention of mental imagery
| Study group | Role | What they receive |
|---|---|---|
| Resistance Exercise Training | Experimental | 12-weeks of high-intensity, progressive resistance exercise training (3x/wk). Receives: Other: Resistance Exercise Training |
| Mental Imagery | Experimental | 6-weeks of mental imagery of strong muscle contractions and mobility tasks (5x/wk). Receives: Other: Mental Imagery |
| Control Group | No intervention | 6-weeks of no change in lifestyle. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor cortical excitability
Obtained using transcranial magnetic stimulation
Measured: Change from baseline measure after 12-weeks for resistance exercise group and 6-weeks for mental imagery and control groups.
Voluntary activation
Obtained based an the ratio of voluntary to electrically stimulated muscle forces
Measured: Change from baseline measure after 12-weeks for resistance exercise group and 6-weeks for mental imagery and control groups.
Secondary outcomes (5)
White matter hyper intensities
Obtained from brain MRI's
Measured: Change from baseline measure after 12-weeks for resistance exercise group and 6-weeks for mental imagery and control groups.
Stair climb power
Time to ascend a flight of stairs
Measured: Change from baseline measure after 12-weeks for resistance exercise group and 6-weeks for mental imagery and control groups.
Motor unit discharge characteristics
Obtained using decomposition EMG
Measured: Change from baseline measure after 12-weeks for resistance exercise group and 6-weeks for mental imagery and control groups.
Memory
Memory assessed via the Repeatable Battery for the Assessment of Neuropsychological Status
Measured: Change from baseline measure after 12-weeks for resistance exercise group and 6-weeks for mental imagery and control groups.
Motor jerkiness
Amount of variability in movement acceleration
Measured: Change from baseline measure after 12-weeks for resistance exercise group and 6-weeks for mental imagery and control groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), University of Florida, Holzer Health System
- Responsible party
- Sponsor
- Investigators
- Brian C Clark, PhD, Principal investigator, Ohio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505529
- Sponsor's protocol ID
- 14F038
- Other IDs
- R01AG044424
- Status last verified
- Mar 2019
- First submitted
- 20 Jul 2015
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Tavoian D, Clark BC, Clark LA, Wages NP, Russ DW. Comparison of strategies for assessment of rate of torque development in older and younger adults. Eur J Appl Physiol. 2024 Feb;124(2):551-560. doi: 10.1007/s00421-023-05299-w. Epub 2023 Aug 25.
PubMed 37624389Wages NP, Simon JE, Clark LA, Amano S, Russ DW, Manini TM, Clark BC. Relative contribution of muscle strength, lean mass, and lower extremity motor function in explaining between-person variance in mobility in older adults. BMC Geriatr. 2020 Jul 28;20(1):255. doi: 10.1186/s12877-020-01656-y.
PubMed 32723298
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanisms of Dynapenia
- ClinicalTrials.gov ID
- NCT02505529
- Acronym / sponsor ID
- 14F038
- Conditions
- Aging
- Keywords
- Aging, Muscle, Weakness, Sarcopenia, Dynapenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), University of Florida, Holzer Health System
- Study start
- Jul 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 22 Jul 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 UNCODE Study seeks to better identify the neurological causes of muscle weakness associated with advancing age. The main study consists of 4 laboratory-based testing sessions that involve testing muscle strength and physical and cognitive function as well as a battery of tests to 1) quantify brain excitability (using non-invasive transcranial magnetic stimulation), 2) modulate brain excitability (using non-invasive transcranial direct current stimulation), 3) spinal motor nerve firing characteristics, and 4) brain structure and function characteristics based on magnetic resonance images of the brain. Additionally, three option sub-studies are also available for enrollment. The first is a genetics sub-study where a cheek swab will be used to examine associations between certain genes and the physiological and functional measures obtained from the main study. The other two sub-studies are interventions. The first sub-study is a progressive resistance exercise training study where study participants will undergo 12-weeks of exercise training (3x/wk) and at the completion of the exercise training the measures obtained in the main study will be re-assessed. The other sub-study is a mental imagery sub-study where subjects are randomly assigned to perform a mental imagery training program consisting of imaging strong muscle contractions and mobility tasks (5x/wk) or to serve as a control (i.e., to not modify lifestyle) for 6-weeks. At the completion of the respective intervention period the measures obtained in the main study will be re-assessed.
Detailed description
The UNCODE Study seeks to better identify the neurological causes of muscle weakness associated with advancing age. The main study consists of 4 laboratory-based testing sessions that involve testing muscle strength and physical and cognitive function as well as a battery of tests to 1) quantify brain excitability (using single and paired pulse transcranial magnetic stimulation of the upper and lower extremity muscles), 2) modulate brain excitability of the upper extremity muscles (using non-invasive transcranial direct current stimulation), 3) spinal motor nerve firing characteristics using decomposition surface electromyography, and 4) brain structure and function characteristics based on magnetic resonance images of the brain. Additionally, three optional sub-studies are also available for enrollment. The first is a genetics sub-study where a cheek swab will be used to examine associations between certain genes (APOE-4 allele) and the physiological and functional measures obtained from the main study. The other two sub-studies are interventions. The first sub-study is a progressive resistance exercise training study where study participants will undergo 12-weeks of exercise training (3x/wk) and at the completion of the exercise training the measures obtained in the main study will be re-assessed. The other sub-study is a mental imagery sub-study where subjects are randomly assigned to perform a mental imagery training program consisting of imaging strong muscle contractions and mobility tasks (5x/wk) or to serve as a control (i.e., to not modify lifestyle) for 6-weeks. At the completion of the respective intervention period the measures obtained in the main study will be re-assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Resistance Exercise Training | Experimental | Other: Resistance Exercise Training12-weeks of high-intensity, progressive resistance exercise training (3x/wk). |
| Mental Imagery | Experimental | Other: Mental Imagery6-weeks of mental imagery of strong muscle contractions and mobility tasks (5x/wk). |
| Control Group | No intervention | –6-weeks of no change in lifestyle. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 60+ 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 16.0 and 40.0 kg/m2.
- With no condition that would limit participation in supervised resistance training exercise based on the Physical Activity Readiness Questionnaire (PAR-Q) (for the "Resistance Exercise Training Sub-Study only).
- Willingness to maintain current diet and adhere to the intervention programs described for the sub-studies (if applicable) and willing to undergo all testing procedures.
- Able to read, understand, and complete study-related questionnaires
Key exclusion criteria (31 listed)
- Failure to provide informed consent.
- Any activity of daily living (ADL) disability (difficulty feeding, dressing, continence, bathing, toileting, and transferring).
- Lives in a nursing home; persons living in assisted or independent housing will not be excluded.
- Cognitive impairment, defined as a known diagnosis of dementia or Modified Mini-Mental State exam score <24
- Known neuromuscular or neurological conditions affecting somatosensory or motor function or control (e.g., hemiplegia, multiple sclerosis, peripheral neuropathy, Parkinson's 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 Exercise TrainingBehavioral interventions of resistance exercise | Other | Resistance Exercise Training |
| Mental ImageryBehavioral intervention of mental imagery | Other | Mental Imagery |
Primary outcome
Motor cortical excitability
Time frame: Change from baseline measure after 12-weeks for resistance exercise group and 6-weeks for mental imagery and control groups.
Obtained using transcranial magnetic stimulation
Voluntary activation
Time frame: Change from baseline measure after 12-weeks for resistance exercise group and 6-weeks for mental imagery and control groups.
Obtained based an the ratio of voluntary to electrically stimulated muscle forces
5 secondary outcomes
White matter hyper intensities
Time frame: Change from baseline measure after 12-weeks for resistance exercise group and 6-weeks for mental imagery and control groups.
Stair climb power
Time frame: Change from baseline measure after 12-weeks for resistance exercise group and 6-weeks for mental imagery and control groups.
Motor unit discharge characteristics
Time frame: Change from baseline measure after 12-weeks for resistance exercise group and 6-weeks for mental imagery and control groups.
Memory
Time frame: Change from baseline measure after 12-weeks for resistance exercise group and 6-weeks for mental imagery and control groups.
Motor jerkiness
Time frame: Change from baseline measure after 12-weeks for resistance exercise group and 6-weeks for mental imagery and control groups.
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 13 Mar 2019.
- Derived from this study: PubMed 37624389Tavoian D, Clark BC, Clark LA, Wages NP, Russ DW. Comparison of strategies for assessment of rate of torque development in older and younger adults. Eur J Appl Physiol. 2024 Feb;124(2):551-560. doi: 10.1007/s00421-023-05299-w. Epub 2023 Aug 25.
- Derived from this study: PubMed 32723298Wages NP, Simon JE, Clark LA, Amano S, Russ DW, Manini TM, Clark BC. Relative contribution of muscle strength, lean mass, and lower extremity motor function in explaining between-person variance in mobility in older adults. BMC Geriatr. 2020 Jul 28;20(1):255. doi: 10.1186/s12877-020-01656-y.
- Ohio Musculoskeletal and Neurological Institute (OMNI) WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
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 principal investigator
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 Exercise Training and Mental Imagery in people with 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 31 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 13 Mar 2019. 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?
Motor cortical excitability (time frame: Change from baseline measure after 12-weeks for resistance exercise group and 6-weeks for mental imagery and control groups.). 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 NCT02505529, which also lists 2 linked publications.
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 13 Mar 2019.