Trial Outcomes & Findings for Time Course Adaptations Using Deuterated Creatine (D3Cr) Method (NCT NCT03573583)
NCT ID: NCT03573583
Last Updated: 2024-07-03
Results Overview
Change in Muscle mass measured using D3Cr
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
Baseline and week 16
Results posted on
2024-07-03
Participant Flow
Participants were recruited from the community using flyers, posters, and mass mailings. The eligibility criteria included men and women aged 70 years or older, who were at high risk for mobility disability based on lower extremity functional limitations measured by the Short Physical Performance Battery (SPPB) with a score of 9 or lower out of 12, and not participating in a structured exercise program, and not using strength exercises in the past 6 months.
A total of 54 participants were assessed for eligibilty and 33 were excluded ( 23 not meeting inclusion criteria (18 SPPB out of range) and 10 withdrew pre-randomization). Twenty-one participants met eligibility criteria and were subsequently randomized into 2 groups
Participant milestones
| Measure |
Resistance Training Group (RT)
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
Resistance 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 Aging
The comparator group will meet for stretching and health education classes every 2-5 weeks up to 7 total visits.
Successful Aging: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
COMPLETED
|
8
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Resistance Training Group (RT)
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
Resistance 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 Aging
The comparator group will meet for stretching and health education classes every 2-5 weeks up to 7 total visits.
Successful Aging: 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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Time Course Adaptations Using Deuterated Creatine (D3Cr) Method
Baseline characteristics by cohort
| Measure |
Resistance Training Group (RT)
n=10 Participants
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
Resistance 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 Aging
n=11 Participants
The comparator group will meet for stretching and health education classes every 2-5 weeks up to 7 total visits.
Successful Aging: 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.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
80.4 years
STANDARD_DEVIATION 5.8 • n=99 Participants
|
83.6 years
STANDARD_DEVIATION 5.4 • n=107 Participants
|
82 years
STANDARD_DEVIATION 5.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Short Physical Performance Battery Score
|
6.7 units on a scale
STANDARD_DEVIATION 0.8 • n=99 Participants
|
6.9 units on a scale
STANDARD_DEVIATION 1.6 • n=107 Participants
|
6.8 units on a scale
STANDARD_DEVIATION 1.2 • n=206 Participants
|
|
Body Mass Index (BMI)
|
30 kg/m^2.
STANDARD_DEVIATION 3.3 • n=99 Participants
|
30 kg/m^2.
STANDARD_DEVIATION 3.3 • n=107 Participants
|
30 kg/m^2.
STANDARD_DEVIATION 3.3 • n=206 Participants
|
|
D3Cr Muscle Mass
|
17.3 Kg
STANDARD_DEVIATION 4.2 • n=99 Participants
|
18 Kg
STANDARD_DEVIATION 4.9 • n=107 Participants
|
17.65 Kg
STANDARD_DEVIATION 4.6 • n=206 Participants
|
|
DXA Appendicular Lean Mass
|
16.4 kg
STANDARD_DEVIATION 4.2 • n=99 Participants
|
17.6 kg
STANDARD_DEVIATION 4.6 • n=107 Participants
|
17 kg
STANDARD_DEVIATION 4.4 • n=206 Participants
|
|
DXA Lean Body Mass
|
44.2 Kg
STANDARD_DEVIATION 11.3 • n=99 Participants
|
42.2 Kg
STANDARD_DEVIATION 8.9 • n=107 Participants
|
43.2 Kg
STANDARD_DEVIATION 10.1 • n=206 Participants
|
|
DXA Fat Mass
|
35.8 Kg
STANDARD_DEVIATION 8.3 • n=99 Participants
|
34.4 Kg
STANDARD_DEVIATION 5.2 • n=107 Participants
|
35.1 Kg
STANDARD_DEVIATION 6.75 • n=206 Participants
|
|
Number of Participants with College Education or Higher
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Number of Participants taking Medications for High Blood Pressure
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Number of Participants taking Medications for Diabetes
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Number of Participants taking Medications for High Cholesterol
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Number of Partcipants who had Cancer.
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Number of participants with Lung Disease
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Number of Partcipants who had a Stroke
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Number of Partcipants who had Myocardial Infarction or Major Heart Surgery
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and week 16Change in Muscle mass measured using D3Cr
Outcome measures
| Measure |
Resistance Training Group (RT)
n=10 Participants
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
Resistance 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 Aging
n=11 Participants
The comparator group will meet for stretching and health education classes every 2-5 weeks up to 7 total visits.
Successful Aging: 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.
|
|---|---|---|
|
Muscle Mass
|
3.47 Kg
Standard Deviation 2.01
|
1.19 Kg
Standard Deviation 1.70
|
SECONDARY outcome
Timeframe: Baseline and week 16Change in ALM by dual-energy x-ray absorptiometry (DEXA)
Outcome measures
| Measure |
Resistance Training Group (RT)
n=10 Participants
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
Resistance 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 Aging
n=11 Participants
The comparator group will meet for stretching and health education classes every 2-5 weeks up to 7 total visits.
Successful Aging: 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.
|
|---|---|---|
|
Appendicular Lean Mass (ALM)
|
0.81 Kg
Standard Deviation 0.68
|
-0.23 Kg
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: Baseline, and Week 16Change in LBM assessed using DXA
Outcome measures
| Measure |
Resistance Training Group (RT)
n=10 Participants
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
Resistance 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 Aging
n=11 Participants
The comparator group will meet for stretching and health education classes every 2-5 weeks up to 7 total visits.
Successful Aging: 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.
|
|---|---|---|
|
Lean Body Mass (LBM)
|
1.10 Kg
Standard Deviation 1.44
|
-0.19 Kg
Standard Deviation 0.93
|
SECONDARY outcome
Timeframe: Baseline and Week 15Population: We want to analyze the correlation between DXA ALM and D3Cr muscle mass. Hence, the two groups are combined to calculate the correlation of DXA ALM compared to D3Cr muscle mass in all the participants rather than individual groups.
Correlation between longitudinal changes in D3 Cr muscle mass (MM) and DXA appendicular lean mass (ALM)
Outcome measures
| Measure |
Resistance Training Group (RT)
n=18 Participants
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
Resistance 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 Aging
The comparator group will meet for stretching and health education classes every 2-5 weeks up to 7 total visits.
Successful Aging: 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.
|
|---|---|---|
|
Correlation Between Changes in Muscle Mass
|
0.19 Pearson Correlation Coefficient
Interval -0.35 to 0.64
|
—
|
Adverse Events
Resistance Training Group (RT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Successful Aging
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place