NCT00749983

Brief Summary

The purpose of this study is to determine whether creatine associated or not to exercise training can improve physical performance in patients with knee osteoarthritis and fibromyalgia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable knee-osteoarthritis

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

September 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2008

Completed
9 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

October 2, 2012

Status Verified

October 1, 2012

Enrollment Period

3.1 years

First QC Date

September 9, 2008

Last Update Submit

October 1, 2012

Conditions

Knee OsteoarthritisFibromyalgia

Outcome Measures

Primary Outcomes (1)

  • Physical function

    Assessed by the timed-stands test

    12 weeks

Secondary Outcomes (4)

  • Strength

    12 weeks

  • Quality of life

    12 weeks

  • Body composition

    12 weeks

  • Renal function

    12 weeks

Study Arms (2)

1

EXPERIMENTAL

creatine intake

Dietary Supplement: Creatine supplementation

2

PLACEBO COMPARATOR

placebo (dextrose) intake

Dietary Supplement: Dextrose supplementation

Interventions

Creatine supplementationDIETARY_SUPPLEMENT
1
Dextrose supplementationDIETARY_SUPPLEMENT
2

Eligibility Criteria

Age25 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fulfill ACR criteria of knee osteoarthritis
  • Fulfill ACR criteria of fibromyalgia

You may not qualify if:

  • Athletes
  • Drugs stable for at least three months before entering the study
  • No limitations to resistance training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo School of Medicine

São Paulo, São Paulo, 01246903, Brazil

Location

MeSH Terms

Conditions

Osteoarthritis, KneeFibromyalgia

Interventions

Creatine

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesMuscular DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

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

Study Record Dates

First Submitted

September 9, 2008

First Posted

September 10, 2008

Study Start

June 1, 2009

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

October 2, 2012

Record last verified: 2012-10

Locations

BR(1)