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出境医 / 临床实验 / Creatine Supplementation During Resistance Training for People Recovering From Stroke

Creatine Supplementation During Resistance Training for People Recovering From Stroke

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Stroke Dietary Supplement: Creatine monohydrate Dietary Supplement: Placebo Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel groups: creatine and placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Creatine Supplementation and Resistance Training in Stroke Survivors
Actual Study Start Date : May 30, 2019
Actual Primary Completion Date : December 30, 2019
Actual Study Completion Date : May 30, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Creatine
0.3 g/kg/d creatine for 7 days; 0.1 g/kg/d creatine for 63 days
Dietary Supplement: Creatine monohydrate
0.3 g/kg/day for 7 days; 0.1 g/kg/day for 63 days

Placebo Comparator: Placebo
0.3 g/kg/d placebo for 7 days; 0.1 g/kg/d placebo for 63 days
Dietary Supplement: Placebo
0.3 g/kg/day for 7 days; 0.1 g/kg/day for 63 days

Outcome Measures
Primary Outcome Measures :
  1. Walking ability [ Time Frame: Change from baseline to 10 weeks ]
    6-minute walk test (maximal distance)


Secondary Outcome Measures :
  1. Lean tissue mass [ Time Frame: Change from baseline to 10 weeks ]
    Lean tissue mass determined by DXA

  2. Leg muscle thickness [ Time Frame: Change from baseline to 10 weeks ]
    Knee extensor muscle thickness by ultrasound

  3. Arm muscle thickness [ Time Frame: Change from baseline to 10 weeks ]
    Biceps muscle thickness by ultrasound

  4. Leg strength [ Time Frame: Change from baseline to 10 weeks ]
    Leg press 1-repetition maximum

  5. Upper body strength [ Time Frame: Change from baseline to 10 weeks ]
    Chest press 1-repetition maximum

  6. Balance [ Time Frame: Change from baseline to 10 weeks ]
    Berg balance scale to measure balance. Includes 14 sub-scales which are summed. Scoring range is from 0 (worse) to 56 (best)

  7. Cognition [ Time Frame: Change from baseline to 10 weeks ]
    Montreal cognitive assessment to assess cognitive ability. Seven sub-scales which are summed. Scoring range is from 0 (worse) to 30 (best)

  8. Anxiety [ Time Frame: Change from baseline to 10 weeks ]
    General Anxiety Disorder Assessment to assess anxiety. Seven questions whose scores are summed. Scoring range is from 0 (least anxious) to 21 (most anxious)

  9. Depression [ Time Frame: Change from baseline to 10 weeks ]
    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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least 6 months post-stroke

Exclusion Criteria:

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

Locations
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Canada, Saskatchewan
Faculty of Kinesiology and Health Sciences, University of Regina
Regina, Saskatchewan, Canada, S4S 0A2
College of Kinesiology, University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N5B2
Sponsors and Collaborators
University of Saskatchewan
University of Regina
Investigators
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Principal Investigator: Philip Chilibeck, Ph.D. University of Saskatchewan
Principal Investigator: Darren Candow, Ph.D. University of Regina
Tracking Information
First Submitted Date  ICMJE May 6, 2019
First Posted Date  ICMJE May 8, 2019
Last Update Posted Date June 11, 2020
Actual Study Start Date  ICMJE May 30, 2019
Actual Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
Walking ability [ Time Frame: Change from baseline to 10 weeks ]
6-minute walk test (maximal distance)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2019)
  • Lean tissue mass [ Time Frame: Change from baseline to 10 weeks ]
    Lean tissue mass determined by DXA
  • Leg muscle thickness [ Time Frame: Change from baseline to 10 weeks ]
    Knee extensor muscle thickness by ultrasound
  • Arm muscle thickness [ Time Frame: Change from baseline to 10 weeks ]
    Biceps muscle thickness by ultrasound
  • Leg strength [ Time Frame: Change from baseline to 10 weeks ]
    Leg press 1-repetition maximum
  • Upper body strength [ Time Frame: Change from baseline to 10 weeks ]
    Chest press 1-repetition maximum
  • Balance [ Time Frame: Change from baseline to 10 weeks ]
    Berg balance scale to measure balance. Includes 14 sub-scales which are summed. Scoring range is from 0 (worse) to 56 (best)
  • Cognition [ Time Frame: Change from baseline to 10 weeks ]
    Montreal cognitive assessment to assess cognitive ability. Seven sub-scales which are summed. Scoring range is from 0 (worse) to 30 (best)
  • Anxiety [ Time Frame: Change from baseline to 10 weeks ]
    General Anxiety Disorder Assessment to assess anxiety. Seven questions whose scores are summed. Scoring range is from 0 (least anxious) to 21 (most anxious)
  • Depression [ Time Frame: Change from baseline to 10 weeks ]
    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)
Original Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
  • Lean tissue mass [ Time Frame: Change from baseline to 10 weeks ]
    Lean tissue mass determined by DXA
  • Leg muscle thickness [ Time Frame: Change from baseline to 10 weeks ]
    Knee extensor muscle thickness by ultrasound
  • Arm muscle thickness [ Time Frame: Change from baseline to 10 weeks ]
    Biceps muscle thickness by ultrasound
  • Leg strength [ Time Frame: Change from baseline to 10 weeks ]
    Leg press 1-repetition maximum
  • Upper body strength [ Time Frame: Change from baseline to 10 weeks ]
    Chest press 1-repetition maximum
  • Balance [ Time Frame: Change from baseline to 10 weeks ]
    Berg balance scale
  • Cognition [ Time Frame: Change from baseline to 10 weeks ]
    Montreal cognitive assessment
  • Anxiety [ Time Frame: Change from baseline to 10 weeks ]
    General Anxiety Disorder Assessment
  • Depression [ Time Frame: Change from baseline to 10 weeks ]
    CES-D Scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Creatine Supplementation During Resistance Training for People Recovering From Stroke
Official Title  ICMJE The Effect of Creatine Supplementation and Resistance Training in Stroke Survivors
Brief 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel groups: creatine and placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE
  • Dietary Supplement: Creatine monohydrate
    0.3 g/kg/day for 7 days; 0.1 g/kg/day for 63 days
  • Dietary Supplement: Placebo
    0.3 g/kg/day for 7 days; 0.1 g/kg/day for 63 days
Study Arms  ICMJE
  • Experimental: Creatine
    0.3 g/kg/d creatine for 7 days; 0.1 g/kg/d creatine for 63 days
    Intervention: 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
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 10, 2020)
8
Original Estimated Enrollment  ICMJE
 (submitted: May 6, 2019)
34
Actual Study Completion Date  ICMJE May 30, 2020
Actual Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • At least 6 months post-stroke

Exclusion Criteria:

  • creatine supplementation within the past 12 weeks
  • medications affecting muscle function within the past 12 weeks
  • kidney disorders
  • liver disorders
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03941678
Other Study ID Numbers  ICMJE 001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Phil Chilibeck, University of Saskatchewan
Study Sponsor  ICMJE University of Saskatchewan
Collaborators  ICMJE University of Regina
Investigators  ICMJE
Principal Investigator: Philip Chilibeck, Ph.D. University of Saskatchewan
Principal Investigator: Darren Candow, Ph.D. University of Regina
PRS Account University of Saskatchewan
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP