CClinicalTrials.gg
CompletedNCT03941678Updated Jun 11, 2020

Creatine Supplementation During Resistance Training for People Recovering From Stroke

An interventional study of Creatine monohydrate and Placebo in Stroke, sponsored by University of Saskatchewan. Completed at 2 sites in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-11.

Sponsored by University of Saskatchewan · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Stroke

Browse trials for

03

In context

Stroke

7,287 studies on the registry are indexed under Stroke; 2,006 are open to participants now.

This study's enrollment of 8 is below the median of 50 across 5,370 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

University of Saskatchewan is the lead sponsor of 237 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • At least 6 months post-stroke

Exclusion criteria

Exclusion Criteria:

  • creatine supplementation within the past 12 weeks
  • medications affecting muscle function within the past 12 weeks
  • kidney disorders
  • liver disorders
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Creatine

    0.3 g/kg/d creatine for 7 days; 0.1 g/kg/d creatine for 63 days

    Dietary Supplement: Creatine monohydrate

  • Placebo comparator
    Placebo

    0.3 g/kg/d placebo for 7 days; 0.1 g/kg/d placebo for 63 days

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementCreatine monohydrate

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

  • Dietary supplementPlacebo

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

06

What researchers measure

Primary outcomes

  1. Walking ability

    6-minute walk test (maximal distance)

    Time frame: Change from baseline to 10 weeks

Secondary outcomes

  1. Lean tissue mass

    Lean tissue mass determined by DXA

    Time frame: Change from baseline to 10 weeks

  2. Leg muscle thickness

    Knee extensor muscle thickness by ultrasound

    Time frame: Change from baseline to 10 weeks

  3. Arm muscle thickness

    Biceps muscle thickness by ultrasound

    Time frame: Change from baseline to 10 weeks

  4. Leg strength

    Leg press 1-repetition maximum

    Time frame: Change from baseline to 10 weeks

  5. Upper body strength

    Chest press 1-repetition maximum

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: Change from baseline to 10 weeks

07

Study locations

2 sites
  • Faculty of Kinesiology and Health Sciences, University of Regina
    Regina, Saskatchewan S4S 0A2, Canada
  • College of Kinesiology, University of Saskatchewan
    Saskatoon, Saskatchewan S7N5B2, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03941678
Lead sponsor
University of Saskatchewan
Collaborators
University of Regina
Responsible party
Phil Chilibeck (Professor, University of Saskatchewan) — Principal investigator
First posted
May 8, 2019
Start date
May 30, 2019
Primary completion
Dec 30, 2019
Completion
May 30, 2020
Last update
Jun 11, 2020

Study contacts

Philip Chilibeck, Ph.D.
principal investigator · University of Saskatchewan
Darren Candow, Ph.D.
principal investigator · University of Regina

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion