NCT02290275

Brief Summary

The goal of this research project is to determine the effectiveness of creatine supplementation and supported low-load walking exercise for managing systemic inflammatory biomarkers and joint symptoms in individuals diagnosed with chronic symptomatic knee osteoarthritis. The central hypothesis of this investigation is that creatine supplementation and exercise will significantly lower systemic biomarkers of inflammation in patients diagnosed with knee osteoarthritis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 14, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 16, 2016

Status Verified

May 1, 2016

Enrollment Period

1.2 years

First QC Date

November 10, 2014

Last Update Submit

May 12, 2016

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

  • C-reactive protein

    12 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

The subjects in this arm will receive 20 grams of a placebo (maltodextrin) for 1 week and then 5 grams of placebo (maltodextrin) for 11 weeks in addition to their regular diets.

Dietary Supplement: placebo (maltodextrin)

Creatine

EXPERIMENTAL

The subjects in this arm will receive 20 grams of creatine for 1 week and then 5 grams of creatine for 11 weeks in addition to their regular diets.

Dietary Supplement: Creatine

Walking Exercise

EXPERIMENTAL

The subjects in this arm will receive a walking exercise program on a motorized treadmill where they will walk for 30 minutes at 3.1 mph, 3 days per week for 12 weeks.

Other: Walking Exercise

Interventions

CreatineDIETARY_SUPPLEMENT

Subjects will supplement their regular diet with 20 grams of creatine for 1 week and then 5 grams of creatine for the following 11 weeks.

Creatine
Walking ExerciseOTHER

Subjects will walk on a specialized treadmill that lowers the impact of walking by taking up to 80% of their body weight away. The subjects will exercise by walking on this treadmill at 3.1 mph, 3 days per week for 30 minutes per day for 12 weeks.

Walking Exercise
placebo (maltodextrin)DIETARY_SUPPLEMENT

Subjects will supplement their regular diet with 20 grams of maltodextrin for 1 week and then 5 grams of maltodextrin for the following 11 weeks.

Placebo

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (1) Ages 45-65; (2) Body mass index (BMI) over 25 kg/m2; (3) Knee pain when performing normal activities of daily living (walking, squatting, or kneeling); (4) Kellgren \& Lawrence grades II \& III radiographic evidence of mild to moderate knee osteoarthritis in one or both knees.

You may not qualify if:

  • (1) Radiographic evidence of severe knee osteoarthritis; (2) History of traumatic hip, knee, or ankle injury or surgery; (3) Use of crutches or a walking aid during ambulation; (3) History of medical conditions that prevent physical activity; (4) Unable to provide consent due to language barrier or mental status; (5) History of diabetes, cardiovascular disease, or screen positive for ankylosing spondylitis, psoriatic arthritis, chronic reactive arthritis, or renal problems requiring peritoneal dialysis or hemodialysis; (6) Unwillingness or inability to return for follow-up appointments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alison Longo

Winnipeg, Manitoba, R3M 3E4, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Creatinemaltodextrin

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Stephen M Cornish, PhD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 10, 2014

First Posted

November 14, 2014

Study Start

January 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

May 16, 2016

Record last verified: 2016-05

Locations

CA(1)