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Creatine Supplementation During Resistance Training for People Recovering From Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Creatine monohydrate
Placebo
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of Kinesiology and Health Sciences, University of Regina
  • College of Kinesiology, University of Saskatchewan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Creatine

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Walking ability
6-minute walk test (maximal distance)

Secondary Outcome Measures

Lean tissue mass
Lean tissue mass determined by DXA
Leg muscle thickness
Knee extensor muscle thickness by ultrasound
Arm muscle thickness
Biceps muscle thickness by ultrasound
Leg strength
Leg press 1-repetition maximum
Upper body strength
Chest press 1-repetition maximum
Balance
Berg balance scale to measure balance. Includes 14 sub-scales which are summed. Scoring range is from 0 (worse) to 56 (best)
Cognition
Montreal cognitive assessment to assess cognitive ability. Seven sub-scales which are summed. Scoring range is from 0 (worse) to 30 (best)
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)
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)

Full Information

First Posted
May 6, 2019
Last Updated
June 10, 2020
Sponsor
University of Saskatchewan
Collaborators
University of Regina
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1. Study Identification

Unique Protocol Identification Number
NCT03941678
Brief Title
Creatine Supplementation During Resistance Training for People Recovering From Stroke
Official Title
The Effect of Creatine Supplementation and Resistance Training in Stroke Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
May 30, 2019 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
May 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan
Collaborators
University of Regina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel groups: creatine and placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Creatine
Arm Type
Experimental
Arm Description
0.3 g/kg/d creatine for 7 days; 0.1 g/kg/d creatine for 63 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0.3 g/kg/d placebo for 7 days; 0.1 g/kg/d placebo for 63 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Creatine monohydrate
Intervention Description
0.3 g/kg/day for 7 days; 0.1 g/kg/day for 63 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
0.3 g/kg/day for 7 days; 0.1 g/kg/day for 63 days
Primary Outcome Measure Information:
Title
Walking ability
Description
6-minute walk test (maximal distance)
Time Frame
Change from baseline to 10 weeks
Secondary Outcome Measure Information:
Title
Lean tissue mass
Description
Lean tissue mass determined by DXA
Time Frame
Change from baseline to 10 weeks
Title
Leg muscle thickness
Description
Knee extensor muscle thickness by ultrasound
Time Frame
Change from baseline to 10 weeks
Title
Arm muscle thickness
Description
Biceps muscle thickness by ultrasound
Time Frame
Change from baseline to 10 weeks
Title
Leg strength
Description
Leg press 1-repetition maximum
Time Frame
Change from baseline to 10 weeks
Title
Upper body strength
Description
Chest press 1-repetition maximum
Time Frame
Change from baseline to 10 weeks
Title
Balance
Description
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
Title
Cognition
Description
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
Title
Anxiety
Description
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
Title
Depression
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Chilibeck, Ph.D.
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Darren Candow, Ph.D.
Organizational Affiliation
University of Regina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Kinesiology and Health Sciences, University of Regina
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4S 0A2
Country
Canada
Facility Name
College of Kinesiology, University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N5B2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Creatine Supplementation During Resistance Training for People Recovering From Stroke

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