Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000411842
Ethics application status
Approved
Date submitted
6/04/2012
Date registered
12/04/2012
Date last updated
12/04/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Eccentric resistance ergometry in knee osteoarthritis rehabilitation: a randomized clinical trial
Scientific title
The effects of adding eccentric ergometry to standard physiotherapy management on quadriceps strength and physical function in individuals with knee osteoarthritis: a randomized clinical study.
Secondary ID [1] 280279 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
EUREKA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Impairments in lower limb muscular performance in symptomatic knee osteoarthritis. 286235 0
Condition category
Condition code
Musculoskeletal 286451 286451 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 286466 286466 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients randomized to the intervention arm would receive standard physiotherapy treatment and they will exercise on an eccentric ergometer. Both Physiotherapy and ergometry training will be delivered individually. Standard physiotherapy treatment would be delivered by experienced Physiotherapists. Specifically, the standard Physiotherapy treatment comprises a combination of manual therapy and therapeutic exercises. For the manual therapy component, the techniques chosen comprise passive physiological and accessory movements, muscle stretching, and soft tissue mobilization. These techniques will be applied by the treating physiotherapists in accordance to their assessment findings. For the therapeutic-exercises component, the exercises will be supervised by the treating physiotherapists and the exercises consist of (i) active range-of-motion exercises, (ii) muscle strengthening exercises, and (iii) balance and functional training. All manual therapy techniques and therapeutic exercises would be progressed only if the symptoms and signs of OA (pain, knee effusion, and muscle soreness) are decreasing.

Eccentric ergometry training involves cycling on an eccentric ergometer. Exercise intensity will be determined by the Borg’s rating of perceived exertion (RPE) scale. Dosage will be 15 minutes per session. In the absence of increased knee pain, effusion, or excessive fatigue, the patients are allowed to gradually progress from an initial RPE rating of "very very light intensity" on the first session to an RPE rating of “hard intensity" in the subsequent sessions.

Physiotherapy treatment will be delivered twice weekly for the first 3 weeks and once weekly for the next 5 weeks. Each treatment session is 30mins in duration.

Patients will train twice weekly on the eccentric ergometer and each session is 15mins in duration.
Intervention code [1] 284630 0
Rehabilitation
Comparator / control treatment
Patients randomized to the comparator arm would receive standard physiotherapy treatment and they would exercise on a concentric ergometer. Both Physiotherapy and ergometry training will be delivered individually.Standard physiotherapy treatment follows that for the intervention arm.

Concentric ergometry training involves cycling on an concentric ergometer. Exercise intensity will be determined by the Borg’s rating of perceived exertion (RPE) scale. Dosage will be 15 minutes per session. In the absence of increased knee pain, effusion, or excessive fatigue, the patients are allowed to gradually progress from an initial RPE rating of "very very light intensity" on the first session to an RPE rating of “hard intensity" in the subsequent sessions.

Physiotherapy treatment will be delivered twice weekly for the first 3 weeks and once weekly for the next 5 weeks. Each treatment session is 30mins in duration.

Patients will train twice weekly on the concentric ergometer and each session is 15mins in duration.
Control group
Active

Outcomes
Primary outcome [1] 286902 0
Isometric knee extensor torque output measured by an isokinetic dynamometer
Timepoint [1] 286902 0
Baseline assessment and 8 weeks post randomization
Primary outcome [2] 286903 0
Stopwatch-timed fast paced gait speed over a 10-metre course
Timepoint [2] 286903 0
Baseline assessment and 8 weeks post randomization
Secondary outcome [1] 296951 0
Medical Outcomes Survey Short Form-36 (SF-36) physical function and bodily pain
Timepoint [1] 296951 0
Baseline assessment and 8 weeks post randomization
Secondary outcome [2] 296952 0
Knee pain intensity measured by the numeric pain rating scale
Timepoint [2] 296952 0
Baseline assessment and 8 weeks post randomization
Secondary outcome [3] 296954 0
Standing balance as measured using a Nintendo Wii Balance Board
Timepoint [3] 296954 0
Baseline assessment and 8 weeks post randomization
Secondary outcome [4] 296955 0
Bridging (supine position) performance as measured using a Nintendo Wii Balance Board
Timepoint [4] 296955 0
Baseline assessment and 8 weeks post randomization
Secondary outcome [5] 296956 0
Knee passive range-of-motion as measured using goniometry
Timepoint [5] 296956 0
Baseline assessment and 8 weeks post randomization

Eligibility
Key inclusion criteria
(i) Patients with primary medial tibiofemoral OA

(ii) Knee flexion range of motion greater or equal to 100 degrees
Minimum age
50 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Patellofemoral joint symptoms overshadowing tibiofemoral symptoms, as determined from clinical examination

(2) Current or past (within 4 weeks) oral corticosteroid use;

(3) Systemic arthritic conditions;

(4) A previous history of hip or knee joint replacement or tibial osteotomy

(5i) Inability to ambulate 10 metres without a gait aid.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be identified and recruited from the outpatient orthopaedic clinic of a large tertiary institution in Singapore. Once the participant has provided written informed consent, pre-intervention testing would be performed and participants will be randomised into one of two groups: (i) standard Physiotherapy management and cycling on an eccentric ergometer and (ii) standard Physiotherapy management and cycling on a concentric ergometer.

The randomisation schedule will be prepared by a research physiotherapist who is not involved in the study. He will be the only person with access to the schedule, which will be kept in a locked location. To conceal randomisation, consecutively numbered, sealed, opaque envelopes will be used and maintained centrally.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed by random permuted blocks stratified according to gender.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
None
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 4242 0
Singapore
State/province [1] 4242 0
NA

Funding & Sponsors
Funding source category [1] 285054 0
Government body
Name [1] 285054 0
Singhealth Foundation Start-Up Grant
Country [1] 285054 0
Singapore
Primary sponsor type
Hospital
Name
Singapore General Hospital
Address
SINGAPORE GENERAL HOSPITAL
Outram Road
Singapore 169608
Tel: 6222 3322
Fax: 6224 9221
Country
Singapore
Secondary sponsor category [1] 283918 0
None
Name [1] 283918 0
Address [1] 283918 0
Country [1] 283918 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287061 0
SGH Institutional Review Board
Ethics committee address [1] 287061 0
Ethics committee country [1] 287061 0
Singapore
Date submitted for ethics approval [1] 287061 0
31/03/2010
Approval date [1] 287061 0
30/04/2010
Ethics approval number [1] 287061 0
CIRB2010/232/D

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34026 0
Address 34026 0
Country 34026 0
Phone 34026 0
Fax 34026 0
Email 34026 0
Contact person for public queries
Name 17273 0
Yong-Hao Pua
Address 17273 0
Physiotherapy Department
Block 1 Level 1
Singapore General Hospital
Outram Road
Singapore 169608
Country 17273 0
Singapore
Phone 17273 0
+65 90188129
Fax 17273 0
Email 17273 0
[email protected]
Contact person for scientific queries
Name 8201 0
Yong-Hao Pua
Address 8201 0
Physiotherapy Department
Block 1 Level 1
Singapore General Hospital
Outram Road
Singapore 169608
Country 8201 0
Singapore
Phone 8201 0
+65 90188129
Fax 8201 0
Email 8201 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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