Muscle WeaknessPhase 3NCT02188849
Effects of Creatine Supplementation on Muscle Mass and Function Among Older Women Subjected to Resistance Training
A Phase 3 study testing Resistance exercise training and Creatine in people with Muscle Weakness, run by University of Chile at 1 site in Chile.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Weakness
- What is being tested?
- Resistance exercise training and Creatine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChile
- Study dates
- Oct 2014to Aug 2015
- Phase
- Phase 3
- 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 60 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Absence of a significant disability, defined as the capacity to reach the health center by their own means with the use of any aid such as canes or wheelchairs
- Absence of disabling diseases such as cardiac, respiratory, liver or kidney failure or active cancer
- Absence of decompensated diabetes mellitus of hypertension. Diabetic patients with repeated fasting blood glucose levels below 120 mg/dl and a glycosylated hemoglobin below 7% will be allowed to participate. Hypertensive patients in treatment with a blood pressure (measured in at least two occasions) below 140/90 mm Hg will also be allowed.
Who cannot join
- Smoking or excessive consumption of alcohol
- Use of medications that can cause muscle dysfunction or limit exercise capacity such as adrenal steroids, chemotherapeutic agents, statins in high doses (ie more than 40 mg/day of atorvastatin) or muscle relaxants.
- Having a severe osteoarticular disease such as rheumatoid arthritis or severe osteoarthritis, with precludes participating in an exercise training program.
- Recent use of ergogenic supplements such as creatine.
- Being engaged in an active exercise training program.
- Being illiterate or having a level of cognitive dysfunction that precludes the free signature of a written informed consent to participate in the study.
- Any personal or socioeconomic condition that, in opinion of the research team, will hamper the correct compliance of the participant with the research program.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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:
- A complete medical history including medications, previous diseases and surgical procedures.
- Evaluation of usual physical activity using the International Physical Activity Questionnaire (IPAQ) .
- Minimental state examination .
- Mininutritional assessment .
- Measurement of weight, height, waist and hip circumference.
- Measurement of body composition by double energy X ray absorptiometry in a General Electric iDEXA equipment.
- Measurement of rectus femoris cross sectional height using a General Electric LogiQ ultrasonographer. Measurements will be made with the participant in supine position and the tight relaxed. The mid-point between the superior anterior iliac spine and the superior border to the patella will be the measurement point.
- Measurement of quadriceps isometric force using a quadriceps table as previously described .
- Measurement of hand grip strength using a hand grip dynamometer.
- Measurement of 12 minutes walking capacity .
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 group will receive creatine 5 g/day in one dose as a powder to be dissolved in water
- The control group will receive a placebo of similar aspect and taste as creatine.
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:
- A warm-up period of 15 minutes, consisting in walking and cycling in braked bicycle ergometers.
- 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.
- An elongation period lasting 10 minutes that will include elongation in mats and exercise balls.
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.
- Conditions
- Muscle Weakness
- Being tested
- Resistance exercise training, Creatine
- Keywords
- creatine, resistance training, older women, muscle strength
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exercise trainingOther
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.
CreatineDrug
Creatine powder 5 g day
| Study group | Role | What they receive |
|---|---|---|
| Creatine | Experimental | Creatine 5 g/ day Receives: Other: Resistance exercise training; Drug: Creatine |
| Placebo | Placebo comparator | Maltodextrin 5 g/day to be dissolved in water Receives: Other: Resistance exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rectus Femoris Cross Sectional Height
Measurement of rectus femoris cross sectional height in the mid thigh by ultrasound
Measured: Twelve weeks
Secondary outcomes (2)
Quadriceps Isometric Strength
Measurement of quadriceps isometric force using a quadriceps table
Measured: Twelve weeks
Twelve Minutes Walk
Measurement of the distance that a participant can walk during 12 minutes
Measured: Twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startOct 2014
- Primary completionJul 2015
- Study completionAug 2015
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.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Bunout, University of Chile
- Investigators
- Sandra Hirsch, MD, Study director, INTA University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188849
- Sponsor's protocol ID
- Creatine elderly
- Other IDs
- Creatine INTA
- Status last verified
- Oct 2015
- First submitted
- 10 Jul 2014
- Last updated
- 30 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Creatine Supplementation on Muscle Mass and Function Among Older Women Subjected to Resistance Training
- ClinicalTrials.gov ID
- NCT02188849
- Acronym / sponsor ID
- Creatine elderly
- Conditions
- Muscle Weakness
- Keywords
- creatine, resistance training, older women, muscle strength
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 14 Jul 2014 (estimated)
- Results
- Posted 30 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- A complete medical history including medications, previous diseases and surgical procedures.
- Evaluation of usual physical activity using the International Physical Activity Questionnaire (IPAQ) .
- Minimental state examination .
- Mininutritional assessment .
- Measurement of weight, height, waist and hip circumference.
- Measurement of body composition by double energy X ray absorptiometry in a General Electric iDEXA equipment.
- Measurement of rectus femoris cross sectional height using a General Electric LogiQ ultrasonographer. Measurements will be made with the participant in supine position and the tight relaxed. The mid-point between the superior anterior iliac spine and the superior border to the patella will be the measurement point.
- Measurement of quadriceps isometric force using a quadriceps table as previously described .
- Measurement of hand grip strength using a hand grip dynamometer.
- Measurement of 12 minutes walking capacity .
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 group will receive creatine 5 g/day in one dose as a powder to be dissolved in water
- The control group will receive a placebo of similar aspect and taste as creatine.
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:
- A warm-up period of 15 minutes, consisting in walking and cycling in braked bicycle ergometers.
- 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.
- An elongation period lasting 10 minutes that will include elongation in mats and exercise balls.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Creatine | Experimental | Other: Resistance exercise training, Drug: CreatineCreatine 5 g/ day |
| Placebo | Placebo comparator | Other: Resistance exercise trainingMaltodextrin 5 g/day to be dissolved in water |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Absence of a significant disability, defined as the capacity to reach the health center by their own means with the use of any aid such as canes or wheelchairs
- Absence of disabling diseases such as cardiac, respiratory, liver or kidney failure or active cancer
- Absence of decompensated diabetes mellitus of hypertension. Diabetic patients with repeated fasting blood glucose levels below 120 mg/dl and a glycosylated hemoglobin below 7% will be allowed to participate. Hypertensive patients in treatment with a blood pressure (measured in at least two occasions) below 140/90 mm Hg will also be allowed.
Key exclusion criteria (7 listed)
- Smoking or excessive consumption of alcohol
- Use of medications that can cause muscle dysfunction or limit exercise capacity such as adrenal steroids, chemotherapeutic agents, statins in high doses (ie more than 40 mg/day of atorvastatin) or muscle relaxants.
- Having a severe osteoarticular disease such as rheumatoid arthritis or severe osteoarthritis, with precludes participating in an exercise training program.
- Recent use of ergogenic supplements such as creatine.
- Being engaged in an active exercise training program.
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 exercise trainingAll 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. | Other | Creatine, Placebo |
| CreatineCreatine powder 5 g day | Drug | Creatine |
Primary outcome
Rectus Femoris Cross Sectional Height
Time frame: Twelve weeks
Measurement of rectus femoris cross sectional height in the mid thigh by ultrasound
2 secondary outcomes
Quadriceps Isometric Strength
Time frame: Twelve weeks
Twelve Minutes Walk
Time frame: Twelve weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sandra Hirsch, MD study director
INTA University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Resistance exercise training and Creatine in people with Muscle Weakness, run by University of Chile at 1 site in Chile.
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 3 inclusion and 7 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 30 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2015). 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?
Rectus Femoris Cross Sectional Height (time frame: Twelve weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2015.