The UNCODE Study: Unravelling the Neural Contributors Of Dynapenia in Elders

NCT02505529 | Completed

• 2 other identifiers: 14F038R01AG044424
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief 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 (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.

Conditions

Aging

Keywords

Aging; Muscle; Weakness; Sarcopenia; Dynapenia

Outcome Measures

Primary Outcomes (2)

• Motor cortical excitability

  Obtained using transcranial magnetic stimulation

  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

  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

  Change from baseline measure after 12-weeks for resistance exercise group and 6-weeks for mental imagery and control groups.

• Stair climb power

  Change from baseline measure after 12-weeks for resistance exercise group and 6-weeks for mental imagery and control groups.

• Motor unit discharge characteristics

  Change from baseline measure after 12-weeks for resistance exercise group and 6-weeks for mental imagery and control groups.

• Memory

  Change from baseline measure after 12-weeks for resistance exercise group and 6-weeks for mental imagery and control groups.

• Motor jerkiness

  Change from baseline measure after 12-weeks for resistance exercise group and 6-weeks for mental imagery and control groups.

Study Arms (3)

Resistance Exercise Training

EXPERIMENTAL

12-weeks of high-intensity, progressive resistance exercise training (3x/wk).

Other: Resistance Exercise Training

Mental Imagery

EXPERIMENTAL

6-weeks of mental imagery of strong muscle contractions and mobility tasks (5x/wk).

Other: Mental Imagery

Control Group

NO INTERVENTION

6-weeks of no change in lifestyle.

Interventions

Resistance Exercise Training OTHER

Behavioral interventions of resistance exercise

Resistance Exercise Training

Mental Imagery OTHER

Behavioral intervention of mental imagery

Mental Imagery

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Ohio University: lead
• National Institute on Aging (NIA): collaborator
• University of Florida: collaborator
• Holzer Health System: collaborator

Study Sites (1)

Ohio Musculoskeletal and Neurological Institute (OMNI) at Ohio University

Athens, Ohio, 45701, United States

Location

Related Publications (2)

• 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.

  PMID: 37624389 DERIVED

• Wages 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.

  PMID: 32723298 DERIVED

Related Links

• Ohio Musculoskeletal and Neurological Institute (OMNI) Website

MeSH Terms

Conditions

Asthenia; Sarcopenia

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Brian C Clark, PhD

  Ohio University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2015
• First Posted: July 22, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 13, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)