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| ID | Type | Description | Link |
|---|---|---|---|
| Creatine INTA | Other Identifier | INTA U de Chile |
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To determine, in a double blind trial, the effects of creatine supplementation during 12 weeks on muscle mass and function of community living older women subjected to resistance training. Material and methods: Fifty healthy older women will be selected for the study. All participants will be subjected to a progressive resistance training program using elastic bands and weights, consisting in three sessions per week lasting 1 hour. Participant will be randomly allocated in a double blind fashion, to receive creatine 5 g per day or an identical placebo. The training and supplementation period will last 12 weeks. At baseline and at the end of the study, body composition will be measured by dual energy x-ray absorptiometry, rectus femoris cross sectional height and surface will be measured by ultrasound, quadriceps strength will be measured in a quadriceps table and 12 minutes' walk will be assessed. The main outcome measure will be quadriceps cross sectional height. Expected results: We expect that creatine supplementation will increase rectus femoris height over and above the effect of resistance training.
Healthy women of middle and low socioeconomic level, living in the community and aged between 60 and 75 years, will be invited to participate in this study.
At baseline and after signing an informed consent form, the following assessments will be carried out:
After performing the baseline assessment, participants will be randomized in one of two groups, balancing by age and nutritional status, using a double blind design:
The active prescription and the placebo will be identified by a unique numeric code. The codes will be known by an external professional, not involved in the research. In case of adverse events, the opening of a specific patient code of a will be requested to this professional, who will decide the pertinence of the request. Thus, even breaking one code, the double blind will be maintained for the rest of participants
All participants will be incorporated to an exercise training program, that will last 12 weeks, with three sessions per week. Each exercise session will consist of:
The attendance of participants to each session, their level of engagement with the exercise protocol and the overall Borg score will be recorded. All adverse events will be also recorded following good clinical practice guidelines Every two weeks, a new supply of the research prescription will be delivered. Participants will be requested to return the unused sachets to have an approximate assessment of compliance.
At the end of 12 weeks of intervention, all the assessments done at baseline will be repeated.
All the information of participants will be recorded in encrypted INTERNET databases. Only researchers will have access to the information, but participants will be informed about the results of all assessments.
Main outcome measure and calculation of sample size:
The main outcome will be rectus femoris cross sectional height. According to previously published results, this parameter increases from 20 ± 3.2 to 24.3 ± 3.8 mm after a training period of 12 weeks . If we expect a 15% difference in rectus femoris cross sectional height at the end of the intervention period, we would require 19 participants per group to obtain differences with an α of 0.05 and a power of 0.8- Considering an attrition rate of 30% during training, we would require 25 participants per group.
Analysis of results:
An intention to treat analysis will be performed. Also a safety analysis will also be carried out, considering all participants that took at least one dose of creatine or placebo. According to the normality of variable distribution, parametric or non-parametric tests will be used to analyze differences.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Creatine | Experimental | Creatine 5 g/ day |
|
| Placebo | Placebo Comparator | Maltodextrin 5 g/day to be dissolved in water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resistance exercise training | Other | All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant. |
| Measure | Description | Time Frame |
|---|---|---|
| Rectus Femoris Cross Sectional Height | Measurement of rectus femoris cross sectional height in the mid thigh by ultrasound | Twelve weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quadriceps Isometric Strength | Measurement of quadriceps isometric force using a quadriceps table | Twelve weeks |
| Twelve Minutes Walk | Measurement of the distance that a participant can walk during 12 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Creatinine | Serum creatinine levels | Twelve weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandra Hirsch, MD | INTA University of Chile | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INTA University of Chile | Santiago | Metropolitan | 7830489 | Chile |
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| ID | Title | Description |
|---|---|---|
| FG000 | Creatine | Creatine 5 g/ day Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant. Creatine: Creatine powder 5 g day |
| FG001 | Placebo | Maltodextrin 5 g/day to be dissolved in water Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Creatine | Creatine 5 g/ day Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant. Creatine: Creatine powder 5 g day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rectus Femoris Cross Sectional Height | Measurement of rectus femoris cross sectional height in the mid thigh by ultrasound | Posted | Mean | Standard Deviation | cm | Twelve weeks |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Creatine | Creatine 5 g/ day Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant. Creatine: Creatine powder 5 g day |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Falls | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sandra Hirsch MD | Institute of Nutrition and Food Technology University of Chile | +56 229781485 | shirsch@inta.uchile.cl |
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| ID | Term |
|---|---|
| D018908 | Muscle Weakness |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| D003401 | Creatine |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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|
| Creatine | Drug | Creatine powder 5 g day |
|
| Twelve weeks |
| BG001 | Placebo | Maltodextrin 5 g/day to be dissolved in water Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Maltodextrin 5 g/day to be dissolved in water Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant. |
|
|
| Secondary | Quadriceps Isometric Strength | Measurement of quadriceps isometric force using a quadriceps table | Posted | Mean | Standard Deviation | Newtons | Twelve weeks |
|
|
|
| Secondary | Twelve Minutes Walk | Measurement of the distance that a participant can walk during 12 minutes | Posted | Mean | Standard Deviation | meters | Twelve weeks |
|
|
|
| Other Pre-specified | Serum Creatinine | Serum creatinine levels | Posted | Mean | Standard Deviation | mg/dl | Twelve weeks |
|
|
|
| 0 |
| 25 |
| 11 |
| 22 |
| EG001 | Placebo | Maltodextrin 5 g/day to be dissolved in water Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant. | 0 | 25 | 8 | 17 |
| Gastroinftestinal symptoms | Gastrointestinal disorders | Systematic Assessment |
|
| Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fever | Infections and infestations | Systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |