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StrokeNCT03941678

Creatine Supplementation During Resistance Training for People Recovering From Stroke

A study testing Creatine monohydrate in people with Stroke, run by University of Saskatchewan at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Creatine monohydrate is important for sustaining phosphocreatine stores in tissues such as muscle and brain. Phosphocreatine is an important source of energy in these tissues. Supplementation with creatine monohydrate is effective in healthy and clinical populations for improving muscle and brain function. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Stroke
What is being tested?
Creatine monohydrate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
8 participants
Where
2 sitesCanada
Study dates
30 May 2019to 30 May 2020
Phase
Interventional
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • At least 6 months post-stroke

Who cannot join

  • creatine supplementation within the past 12 weeks
  • medications affecting muscle function within the past 12 weeks
  • kidney disorders
  • liver disorders

Trial locations and contacts

2 sites in 1 country.

Canada2 sites
  • Faculty of Kinesiology and Health Sciences, University of Regina

    Regina, Saskatchewan, S4S 0A2

  • College of Kinesiology, University of Saskatchewan

    Saskatoon, Saskatchewan, S7N5B2

Other trials in Canada

About this study

Official title: The Effect of Creatine Supplementation and Resistance Training in Stroke Survivors

Creatine monohydrate is important for sustaining phosphocreatine stores in tissues such as muscle and brain. Phosphocreatine is an important source of energy in these tissues. Supplementation with creatine monohydrate is effective in healthy and clinical populations for improving muscle and brain function. The purpose of our study is to determined whether creatine supplementation is effective during resistance training for improving muscle and brain function in people recovering from stroke.

Read the detailed description

The purpose of this study is to determine the effects of creatine supplementation and supervised resistance training in stroke survivors. It is hypothesized that creatine supplementation and resistance training will increase whole-body lean tissue mass, limb muscle thickness, muscle strength, tasks of functionality and cognition and decrease symptoms of depression and anxiety compared to placebo and resistance training.

Stroke is characterized by an abrupt disturbance in cerebral circulation causing a neurological deficit. It is a major cause of adult neurological disability in North America, often resulting in significant muscle loss, weakness and functional limitations. Disability associated with stroke limits independent living and social participation in at least half of all stroke survivors. A sedentary lifestyle after stroke can increase the risk for recurrent stroke, cardiovascular disease, and diabetes mellitus. All factors may adversely affect independence and quality of life. The majority of stroke survivors have residual impairments such as hemiparesis, spasticity, cognitive dysfunction, and aphasia, with full recovery reached in a small portion of these individuals. One of the major consequences of these impairments is physical inactivity which inevitably contributes to muscle loss, decreased muscle function (i.e. strength, endurance) and impaired functionality. One intervention which may help improve muscle mass, muscle function and functionality in stroke survivors is supervised resistance training. Resistance training does not lead to muscle spasticity in stroke survivors and has been shown to improve the ability to perform activities of daily living. Another intervention which may be beneficial for stroke survivors is creatine supplementation. Creatine has been shown to increase muscle mass, muscle function and tasks of functionality when combined with resistance training, possibly by influencing cellular hydration status, high-energy phosphate metabolism, muscle protein kinetics, satellite cells, anabolic growth factors, and inflammation. Creatine has also shown promise for improving cognition and symptoms of depression and anxiety; however, no study has examined the combined effects of creatine supplementation and resistance training in stroke survivors.

The study will be a double-blind, repeated measures design. In order to minimize group differences, participants will be matched according to age, gender, and type of stroke and then be randomized on a 1:1 basis to one of two groups, creatine monohydrate or placebo (corn-starch maltodextrin). Creatine and placebo will be similar in taste, color, texture and appearance. A research assistant will be responsible for randomization and another research assistant will prepare study kits. Each study kit will contain the participants supplement for the duration of the study, detailed supplementation instructions, as well as measuring spoons. For days 1-7, participants will ingest 0.3g/kg of creatine or placebo (0.075 g/kg x 4 times daily). This creatine dosing strategy has been shown to be effective for increasing intramuscular creatine stores. For subsequent days, participants will consume 0.1 g/kg/day of creatine or placebo as this creatine dosage is effective for increasing muscle mass. On training days, participants will consume their supplement within 5 minutes after each training session. On non-training days, supplements will be consumed at the participants leisure. Adherence with creatine supplementation, placebo, and resistance training will be assessed by training and supplementation compliance logs. A retrospective treatment identification will be administered to all participants upon completion of the study in order to assess whether participants thought they were administered creatine, placebo, or unsure about what supplement they consumed.

The dependent variables that will be measured at baseline and after the intervention include: (1) whole-body lean tissue mass (dual energy x-ray absorptiometry) (2) muscle thickness (elbow and knee flexors and extensors; ultrasonography), (3) muscle strength (1-repetition maximum leg press and chest press), (4) tasks of functionality (berg balance scale, 6-minute walk test) (5) cognition (Montreal Cognitive Assessment), (6) depression (The Center for Epidemiologic Studies- Depression Scale) and anxiety (Generalized Anxiety Disorder 7-item). Participants will also complete a 3-day food log at baseline and during the last week of supplementation and training to determine whether total calories consumed as well as macronutrient intake changed over the duration of the study. Participants will be instructed to record all food and beverages consumption during these 3 days. Food records will be analyzed using MyFitnessPal.

Conditions
Stroke
Being tested
Creatine monohydrate, Placebo
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Creatine monohydrateDietary supplement

    0.3 g/kg/day for 7 days; 0.1 g/kg/day for 63 days

  • PlaceboDietary supplement

    0.3 g/kg/day for 7 days; 0.1 g/kg/day for 63 days

Study groups in NCT03941678
Study groupRoleWhat they receive
CreatineExperimental0.3 g/kg/d creatine for 7 days; 0.1 g/kg/d creatine for 63 days
Receives: Dietary Supplement: Creatine monohydrate
PlaceboPlacebo comparator0.3 g/kg/d placebo for 7 days; 0.1 g/kg/d placebo for 63 days
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Walking ability

    6-minute walk test (maximal distance)

    Measured: Change from baseline to 10 weeks

Secondary outcomes (9)
  1. Lean tissue mass

    Lean tissue mass determined by DXA

    Measured: Change from baseline to 10 weeks

  2. Leg muscle thickness

    Knee extensor muscle thickness by ultrasound

    Measured: Change from baseline to 10 weeks

  3. Arm muscle thickness

    Biceps muscle thickness by ultrasound

    Measured: Change from baseline to 10 weeks

  4. Leg strength

    Leg press 1-repetition maximum

    Measured: Change from baseline to 10 weeks

  5. Upper body strength

    Chest press 1-repetition maximum

    Measured: Change from baseline to 10 weeks

  6. Balance

    Berg balance scale to measure balance. Includes 14 sub-scales which are summed. Scoring range is from 0 (worse) to 56 (best)

    Measured: Change from baseline to 10 weeks

  7. Cognition

    Montreal cognitive assessment to assess cognitive ability. Seven sub-scales which are summed. Scoring range is from 0 (worse) to 30 (best)

    Measured: Change from baseline to 10 weeks

  8. Anxiety

    General Anxiety Disorder Assessment to assess anxiety. Seven questions whose scores are summed. Scoring range is from 0 (least anxious) to 21 (most anxious)

    Measured: Change from baseline to 10 weeks

  9. Depression

    Center for Epidemiologic Depression (CES-D) Scale to assess depression. Twenty questions whose scores are summed. Scoring range is from 0 (least depressed) to 60 (most depressed)

    Measured: Change from baseline to 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2019
  2. Study start30 May 2019
  3. Primary completion30 Dec 2019
  4. Study completion30 May 2020

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel groups: creatine and placebo
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03941678
Sponsor's protocol ID
001
Status last verified
Jun 2020
First submitted
6 May 2019
Last updated
11 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Creatine monohydrate in people with Stroke, run by University of Saskatchewan at 2 sites in Canada.

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 1 inclusion and 4 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 11 Jun 2020. 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 Canada. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Walking ability (time frame: Change from baseline to 10 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 11 Jun 2020.

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