SarcopeniaNCT03573583
Time Course Adaptations Using Deuterated Creatine (D3Cr) Method
A study testing Resistance Training and Successful Aging in people with Sarcopenia, run by University of Florida at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Resistance Training and Successful Aging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2019to 1 Aug 2020
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 25Show fewer
- 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
- Currently enrolled in another randomized trial involving a pharmaceutical or lifestyle intervention. Observational studies are permitted
- Participation in progressive resistance exercise regimen ( ≥1 day/week) within the previous 6 months prior to screening.
- Weight change (intentional or not) over the last 6 months of > 5% of body or plan to lose or gain weight during the study
- Any other cardiovascular, pulmonary, orthopedic, neurologic, or other conditions that in the opinion of the local clinician would preclude participation and successful completion of the protocol
- Temporary Exclusion Criteria:
- Recent bacterial/viral infection (e.g. pneumonia) (< 2 weeks);
- Acute febrile illness in past 2 months;
- Severe hypertension, e.g., SBP > 200 mm Hg, DBP > 110 mm Hg
- Major surgery or fracture or hip/knee replacement (< 6 months);
- Hospitalization within the last 6 months ( Not ER visits)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UF Health at the University of Florida
Gainesville, Florida, 32610
UF Institute on Aging Clinical and Translational Research Building
Gainesville, Florida, 32611
About this study
Official title: Time Course Adaptations Using Deuterated Creatine (D3Cr) Method: A Pilot Study
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.
Read the detailed description
Muscle loss with age is considered to be an important cause of disability in older adults. However, current tools frequently used and recommended to measure muscle mass in trials have limitations: For example, DEXA (Dual-energy X-ray absorptiometry) and BIA (Bioelectrical impedance analysis)- both widely used in clinical trials cannot distinguish muscle tissue from non-muscle elements such as subcutaneous and intramuscular fat, skin, water and connective tissue.
Deuterated creatine (D3Cr) dilution is a novel promising method that provides an accurate measure of the functional contractile tissue, without including the non-contractile elements, by measuring total body creatine. Our preliminary cross-sectional results in men aged >65 years show functional muscle mass (FMM) assessed by D3-Cr to be significantly associated with performance outcomes and long-term outcomes, while DEXA showed no associations. However, these are observational data and cannot determine a causative role of muscle per se on functional outcomes.
Hence, the objective of the pilot study is to assess the feasibility of our proposed future study to evaluate the role of muscle mass on functional outcomes. Specifically, the pilot study will randomize moderate to low-functioning older adults to a resistance training program or successful aging health education program to assess recruitment yields, participant adherence, retention, training program design aspects, sample size, and the cost of the main trial. Further, the impact of these changes in FMM on short-term performance outcomes, such as strength, walking speed, SPPB, self-reported measures, and balance will be examined.
- Conditions
- Sarcopenia
- Being tested
- Resistance Training, Successful Aging
- Keywords
- muscle mass, muscle loss, Deuterated creatine (D3Cr) dilution, older adults, resistance training, physical function
- Medical subject headings
- Sarcopenia, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance TrainingBehavioural
Also called RT, Strength Training, Weight Training
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.
Successful AgingBehavioural
Also called HE, Health Education
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Successful Aging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Mass
Change in Muscle mass measured using D3Cr
Measured: Baseline and week 16
Secondary outcomes (3)
Appendicular Lean Mass (ALM)
Change in ALM by dual-energy x-ray absorptiometry (DEXA)
Measured: Baseline and week 16
Lean Body Mass (LBM)
Change in LBM assessed using DXA
Measured: Baseline, and Week 16
Correlation Between Changes in Muscle Mass
Correlation between longitudinal changes in D3 Cr muscle mass (MM) and DXA appendicular lean mass (ALM)
Measured: Baseline and Week 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start1 Feb 2019
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Todd Manini, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573583
- Sponsor's protocol ID
- IRB201801249 - N
- Other IDs
- P30AG028740
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2018
- Last updated
- 3 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36752568
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Course Adaptations Using Deuterated Creatine (D3Cr) Method: A Pilot Study
- ClinicalTrials.gov ID
- NCT03573583
- Acronym / sponsor ID
- IRB201801249 - N
- Conditions
- Sarcopenia
- Keywords
- muscle mass, muscle loss, Deuterated creatine (D3Cr) dilution, older adults, resistance training, physical function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 29 Jun 2018 (actual)
- Results
- Posted 3 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Muscle loss with age is considered to be an important cause of disability in older adults. However, current tools frequently used and recommended to measure muscle mass in trials have limitations: For example, DEXA (Dual-energy X-ray absorptiometry) and BIA (Bioelectrical impedance analysis)- both widely used in clinical trials cannot distinguish muscle tissue from non-muscle elements such as subcutaneous and intramuscular fat, skin, water and connective tissue.
Deuterated creatine (D3Cr) dilution is a novel promising method that provides an accurate measure of the functional contractile tissue, without including the non-contractile elements, by measuring total body creatine. Our preliminary cross-sectional results in men aged >65 years show functional muscle mass (FMM) assessed by D3-Cr to be significantly associated with performance outcomes and long-term outcomes, while DEXA showed no associations. However, these are observational data and cannot determine a causative role of muscle per se on functional outcomes.
Hence, the objective of the pilot study is to assess the feasibility of our proposed future study to evaluate the role of muscle mass on functional outcomes. Specifically, the pilot study will randomize moderate to low-functioning older adults to a resistance training program or successful aging health education program to assess recruitment yields, participant adherence, retention, training program design aspects, sample size, and the cost of the main trial. Further, the impact of these changes in FMM on short-term performance outcomes, such as strength, walking speed, SPPB, self-reported measures, and balance will be examined.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Resistance Training group (RT) | Experimental | Behavioral: Resistance TrainingThe 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 |
| Successful Aging | Active comparator | Behavioral: Successful AgingThe comparator group will meet for stretching and health education classes every 2-5 weeks up to 7 total visits. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (25 listed)
- 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
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 TrainingAlso: RT, Strength Training, Weight TrainingThe 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. | Behavioural | Resistance Training group (RT) |
| Successful AgingAlso: HE, Health EducationThe 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. | Behavioural | Successful Aging |
Primary outcome
Muscle Mass
Time frame: Baseline and week 16
Change in Muscle mass measured using D3Cr
3 secondary outcomes
Appendicular Lean Mass (ALM)
Time frame: Baseline and week 16
Lean Body Mass (LBM)
Time frame: Baseline, and Week 16
Correlation Between Changes in Muscle Mass
Time frame: Baseline and Week 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36752568Balachandran 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.
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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.
Todd Manini, PhD principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training and Successful Aging in people with Sarcopenia, run by University of Florida 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 25 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 3 Jul 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 3 Jul 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?
Muscle Mass (time frame: Baseline and week 16). 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 NCT03573583, 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 3 Jul 2024.