Preoperative Strength Training in Patients With Total Knee Arthroplasty

Osteoarthritis, Knee Clinical Trial

Official title:

Effect of Preoperative Strength Training on Postoperative Quadriceps Strength and Ability of Function in Patients With Total Knee Arthroplasty in Fast Track Regi

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01647243
• Other study ID #: M-20110181
• Status: Recruiting
• Phase: N/A
• First received: July 13, 2012
• Last updated: July 20, 2012
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: July 2012
• Source: University of Aarhus
• Contact: Birgit Sørensen Skoffer, MPH
• Phone: +45 50 42 28 30
• Email: BSkoffer[@]dadlnet.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate if preoperative strength training will result in faster recovery and higher level of function six weeks after total knee arthroplasty (TKA).

Description:

Reduced strength of the quadriceps muscle is a common clinical finding in patients with Knee Osteoarthritis and this seems to play a central role in the development of the disease. The strength of the quadriceps muscle have been shown to be reduced by 20-40% as compared to age-matched healthy controls and this decrease in muscle strength have been closely associated with a reduced level of function and increase of pain. Furthermore, it has been demonstrated that the preoperative strength of the quadriceps muscle in patients undergoing TKA, is associated with the level of function one year after surgery. Compared to the level before the operation, an additional operation-induced reduction of the strength of the quadriceps muscle up to 60% as has been demonstrated. Presumably, an optimizing of the strength of the quadriceps muscle could counteract the impact of the expected postoperative loss of muscle strength to such an extent that the loss will be of less clinical significance. It is hypothesized that an optimizing of the strength of the quadriceps muscle may have a favorable effect on the postoperative rehabilitation program and shorten the period of convalescence.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Planned TKA at the Aarhus University Hospital or Region Hospital Silkeborg,

• Living in Aarhus Municipality,

• Primary knee osteoarthritis or secondary osteoarthritis after meniscectomy or ligament injury

Exclusion Criteria:

• Unstable blood pressure,

• Neuromuscular or neurodegenerative disease,

• Comprehension or dementia problems

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Preoperative strength training
Progressive strength training on group basis (not more than 3 subjects) 3 sessions weekly starting 4 weeks before the operation, in total 12 sessions Strength training 3 sessions weekly 4 weeks postsurgery

Locations

Country	Name	City	State
Denmark	Aarhus University hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome: Sit-to-stand test	Ability of function test	Change from Baseline 6 weeks preoperative in Sit-to-Stand at 6 weeks postoperative	No
Secondary	Isokinetic: Quadriceps 60 gr./sek	Muscle strength test in dynamometer	6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation	No
Secondary	Isokinetic: Hamstrings 60 gr./sek	Muscle strength test in dynamometer	6 weeks and 1 week before the operation, 1 week, 6 weeks 12 weeks and 1 year after the operation	No
Secondary	Isometric: Quadriceps (70 gr. flexion)	Muscle strength test in dynamometer	6 weeks and 1 week before the operation and 11 week, 6 weeks, 12 weeks and 1 year after the operation	No
Secondary	Isometric: Hamstrings (20 gr. flexion)	Muscle strength test in dynamometer	6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation	No
Secondary	Rate of force development (flexion and extension)	Muscle test in dynamometer	6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation	No
Secondary	Timed Up and Go	Ability of function test	6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation	No
Secondary	10 meter walk test	Ability of function test	6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation	No
Secondary	6 minute walk test	Ability of function test	6 weeks and 1 week before operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation	No
Secondary	Knee injury and Osteoarthritis Outcome Score (KOOS)	Disease-specific questionnaire	6 weeks and 1 week before operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation	No
Secondary	Oxford Knee Score (OKS)	Disease-specific questionnaire	6 weeks before the operation and 6 weeks after	No
Secondary	EuroQol-5 dimensions (EQ-5D)	Generic questionnaire for self-rated health	6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation	No
Secondary	Short-Form Health Survey (SF 12)	Generic questionnaire for self-rated health	6 weeks before the operation and 1 year after	No
Secondary	Background data questionnaire	Questionnaire about pain, medicine use, alcohol intake, smoking, education, job	6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation	No
Secondary	Range of motion of the knee	Extension of the knee Flexion of the knee	6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation	No
Secondary	Body mass index	Weight/height2	6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation	No