Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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:

1. A complete medical history including medications, previous diseases and surgical procedures.

2. Evaluation of usual physical activity using the International Physical Activity Questionnaire (IPAQ) .

3. Minimental state examination .

4. Mininutritional assessment .

5. Measurement of weight, height, waist and hip circumference.

6. Measurement of body composition by double energy X ray absorptiometry in a General Electric iDEXA equipment.

7. 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.

8. Measurement of quadriceps isometric force using a quadriceps table as previously described .

9. Measurement of hand grip strength using a hand grip dynamometer.

10. 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:

1. The active group will receive creatine 5 g/day in one dose as a powder to be dissolved in water

2. 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:

1. A warm-up period of 15 minutes, consisting in walking and cycling in braked bicycle ergometers.

2. 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.

3. 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02188849
Study type Interventional
Source University of Chile
Contact
Status Completed
Phase Phase 3
Start date October 2014
Completion date August 2015

See also
  Status Clinical Trial Phase
Recruiting NCT05543980 - Leg Heat Therapy in Elderly Individuals Phase 2
Enrolling by invitation NCT03297632 - Improving Muscle Strength, Mass and Physical Function in Older Adults N/A
Completed NCT04207359 - Effects of Creatine Supplementation in Breast Cancer Survivors N/A
Completed NCT06216015 - Exercise Training and Kidney Transplantation N/A
Completed NCT04076982 - Effect of Supplementary Dietary Protein (21g Per Day) on Lean Mass and Strength in Sedentary, Adult Vegetarians N/A
Not yet recruiting NCT03662555 - Effect of Neuromuscular Electrical Stimulation Combined With Blood Flow Restriction on Muscular and Cardiovascular Function N/A
Completed NCT02530723 - Functional Changes and Power Training in Older Women. N/A
Completed NCT01743495 - CAPABLE for Frail Dually Eligible Older Adults N/A
Completed NCT01704976 - SR-WBV Training for Frail Elderly in the Skilling up Stage N/A
Completed NCT00183040 - HORMA: Hormonal Regulators of Muscle and Metabolism in Aging Phase 2
Recruiting NCT05073224 - Muscle Function After Childbirth N/A
Completed NCT04956705 - Vitamin D and Calcium Supplementation at Danish Nursing Homes N/A
Recruiting NCT03810768 - Metabolomics Study on Postoperative Intensive Care Acquired Muscle Weakness
Completed NCT00060970 - Evaluating Muscle Function After Ankle Surgery N/A
Completed NCT04546048 - The Early Strength Training Program in Post-transplant Liver Cases N/A
Completed NCT03628365 - Can Beta-Hydroxy-beta-Methylbutyrate Supplementation Counteract Muscle Catabolism in Critically Ill Patients? N/A
Completed NCT05056298 - Effect of Insole Added to Exercise in Patients With Bilateral Flexible Flatfoot N/A
Completed NCT02739464 - Effect of In-Patient Exercise Training on Length of Hospitalization in Burned Patients N/A
Completed NCT05497960 - Vivo Prediabetes Study: Online, Live, and Interactive Strength Training for Older Adults With Prediabetes N/A
Recruiting NCT05182086 - Improving Recovery After Critical Illness N/A