Creatine Supplementation During Resistance Training for People Recovering From Stroke

NCT03941678 | Completed

• 1 other identifier: 001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Walking ability

  6-minute walk test (maximal distance)

  Change from baseline to 10 weeks

Secondary Outcomes (9)

• Lean tissue mass

  Change from baseline to 10 weeks

• Leg muscle thickness

  Change from baseline to 10 weeks

• Arm muscle thickness

  Change from baseline to 10 weeks

• Leg strength

  Change from baseline to 10 weeks

• Upper body strength

  Change from baseline to 10 weeks

Study Arms (2)

Creatine

EXPERIMENTAL

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

Dietary Supplement: Creatine monohydrate

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Creatine monohydrate DIETARY_SUPPLEMENT

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

Creatine

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 6 months post-stroke

You may not qualify if:

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

Sponsors & Collaborators

• University of Saskatchewan: lead
• University of Regina: collaborator

Study Sites (2)

Faculty of Kinesiology and Health Sciences, University of Regina

Regina, Saskatchewan, S4S 0A2, Canada

Location

College of Kinesiology, University of Saskatchewan

Saskatoon, Saskatchewan, S7N5B2, Canada

Location

MeSH Terms

Conditions

Stroke

Interventions

Creatine

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Philip Chilibeck, Ph.D.

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

• Darren Candow, Ph.D.

  University of Regina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Parallel groups: creatine and placebo

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 8, 2019
• Study Start: May 30, 2019
• Primary Completion: December 30, 2019
• Study Completion: May 30, 2020
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)