Time Course Adaptations Using Deuterated Creatine (D3Cr) Method

NCT03573583 | Completed Results DMC

• 2 other identifiers: IRB201801249 - NP30AG028740
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief Summary

The pilot study is to assess the feasibility of using a new method to measure muscle mass called Deuterated Creatine (D3Cr) method and thereby understand the role of muscle mass on functional outcomes in older adults.

Conditions

Sarcopenia

Keywords

muscle mass; muscle loss; Deuterated creatine (D3Cr) dilution; older adults; resistance training; physical function

Outcome Measures

Primary Outcomes (1)

• Muscle Mass

  Change in Muscle mass measured using D3Cr

  Baseline and week 16

Secondary Outcomes (3)

• Appendicular Lean Mass (ALM)

  Baseline and week 16

• Lean Body Mass (LBM)

  Baseline, and Week 16

• Correlation Between Changes in Muscle Mass

  Baseline and Week 15

Study Arms (2)

Resistance Training group (RT)

EXPERIMENTAL

The resistance training intervention will include a full body, resistance training performed three days per week.The intensity, volume, tempo, and progression will be based on the Federal Physical Activity guidelines

Behavioral: Resistance Training

Successful Aging

ACTIVE COMPARATOR

The comparator group will meet for stretching and health education classes every 2-5 weeks up to 7 total visits.

Behavioral: Successful Aging

Interventions

Resistance Training BEHAVIORAL

The intensity, volume, tempo, and progression will be based on the Federal Physical Activity guidelines. The resistance training exercises will include mainly multi-joint exercises using selectorized machines. Each session will include upper body exercises (Chest Press, Shoulder Press, Seated Rows, Bicep curls, and Tricep Extensions) and lower body exercises (Leg Press, Leg Extension and Leg Curls, and Calf raise) that will be tailored to the participant needs.

Also known as: RT, Strength Training, Weight Training

Resistance Training group (RT)

Successful Aging BEHAVIORAL

The successful aging will attend stretching and health lectures as a group . The topics might include, medication management, disease management (e.g. blood pressure, diabetes, arthritis, dementia, pain management, diet) and other health related matters.

Also known as: HE, Health Education

Successful Aging

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• men and women aged 70 or greater
• at high risk for mobility disability based on lower extremity functional limitations measured by Short Physical Performance battery (SPPB) with a score ≤ 8 out of 12
• could safely participate in the resistance training intervention as determined by medical history and physical examination.
• willing to give informed consent to be randomized to either the resistance training group or successful aging heath education comparison group and willing to follow the study protocol

You may not qualify if:

• Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina
• Myocardial infarction, major heart surgery, stroke, deep vein thrombosis, or pulmonary embolus in the past 6 months
• Lung disease requiring either oral or injected steroids, or the use of supplemental oxygen
• Short, portable mental status questionnaire with 3 or more errors
• Severe arthritis (either osteoarthritis or rheumatoid arthritis) that severely limits mobility
• Severe lower back or shoulder pain that can worsen with weight lifting exercises.
• Cancer requiring treatment in the past 1 year (Melanomas excluded)
• Any present or recent history of severe psychiatric illness including depression that might preclude providing informed consent, safe participation, or compliance (self-report and investigator judgement
• Development of chest pain or severe shortness of breath on the 400 m self-paced walk test
• Parkinson's disease or other serious neurological disorders; renal disease requiring dialysis; other illness of such severity that life expectancy is considered to be less than 12 months
• Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
• Current consumption of more than 14 alcoholic drinks per week
• Uncontrolled hypertension (systolic blood pressure \> 200 mm Hg and/or diastolic blood pressure \>110 mm Hg)
• Currently on testosterone, Dehydroepiandrosterone (DHEA), or anabolic steroids.
• Undergoing physical therapy involving the lower extremities

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

UF Health at the University of Florida

Gainesville, Florida, 32610, United States

Location

UF Institute on Aging Clinical and Translational Research Building

Gainesville, Florida, 32611, United States

Location

Related Publications (1)

• Balachandran AT, Evans WJ, Cawthon PM, Wang Y, Shankaran M, Hellerstein MK, Qiu P, Manini T. Comparing D3-Creatine Dilution and Dual-Energy X-ray Absorptiometry Muscle Mass Responses to Strength Training in Low-Functioning Older Adults. J Gerontol A Biol Sci Med Sci. 2023 Aug 27;78(9):1591-1596. doi: 10.1093/gerona/glad047.

  PMID: 36752568 RESULT

MeSH Terms

Conditions

Sarcopenia; Muscular Atrophy

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

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

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

Limitations and Caveats

Our study has several limitations. First, the sample size was relatively small. Clearly, the study needs to be replicated with a larger sample to make definitive statements. Although it is considered a strength in some respects, the results are only applicable to low-functioning older adults. Additional measures of body composition were not included, but would have allowed additional comparisons (eg, whole-body MRI or a 4-compartment model) with D3Cr.

Results Point of Contact

• Title: Todd Manini
• Organization: University of Florida

tmanini@ufl.edu

(352) 273-5914

Study Officials

• Todd Manini, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: To ensure concealment of the allocation, the randomization procedures will be performed by an investigator who are not involved in the assessments. The team assessing study outcomes will be masked to intervention assignment.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The pilot study will be single-blind, parallel group, randomized controlled trial of 24 moderate to low functioning participants randomized in a 1:1 allocation ratio to a high-intensity Resistance Training group (RT) or a Successful Aging Health Education comparator group (HE) for 14 weeks.

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: June 29, 2018
• Study Start: February 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: July 3, 2024
• Results First Posted: July 3, 2024

Record last verified: 2024-06

Locations

US (2)