Early Rehabilitation After Total Hip Replacement

Osteoarthritis, Hip Clinical Trial

Official title:

Early Rehabilitation After Toal Hip Replacement. -Effect of Supervised Progressive Resistance Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01214954
• Other study ID #: M-20090231
• Status: Completed
• Phase: N/A
• First received: September 17, 2010
• Last updated: November 21, 2013
• Start date: September 2010
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether supervised progressive resistance training is effective in the early phase after Total Hip Replacement. The investigators hypothesise that 10 weeks of supervised, progressive resistance training immediately after discharge will lead to increased functional performance, muscle strength and muscle power compared to standard rehabilitation consisting of home-based exercise.

Description:

After total hip replacement (THR) surgery there is a documented deficit in muscle strength and functional performance. There is a lack of evidence concerning the effectiveness of postoperative physiotherapy and training, however a few small studies have shown promising effect of resistance training.

The present study will provide new and important knowledge concerning the effect of different rehabilitation strategies after THR. This might lead to a change in the rehabilitation regimes and faster and better recovery after THR surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: November 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Total hip replacement for osteoarthrosis

• Living within 30 km from the hospital

• Motivated to attend training 2 times/week in 10 weeks

• Reduced functional ability measured as: HOOS score < 67

• written informed consent

Exclusion Criteria:

• Comorbidities such as cancer, neuromuscular diseases, heart diseases etc.

• Cognitive impairment

• Body mass index > 35

• Resurfacing prosthesis

• Scheduled additional prosthetic surgery in lower extremity within 6 months

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, Hip

Intervention

Other:
• Supervised progressive resistance training
Resistance training 2 times/week initiated within the first week after total hip replacement. The training is supervised by physiotherapists and individually progressed.
• Control group
Standard rehabilitation consisting of home-based exercises with 2 postoperative instructions by a physiotherapist.

Locations

Country	Name	City	State
Denmark	Silkeborg Regional Hospital	Silkeborg

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Regionshospitalet Silkeborg

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leg extension power	The power in leg extension is measured using the Nottingham leg extension power rig. Data is provided in watt and adjusted for bodyweight (watt/kg)	10 weeks postoperative	No
Secondary	Walking speed	Maximal walking speed measured over 20 m.	4 weeks postoperative	No
Secondary	Sit-to-stand	The maximal number of rises from a chair within 30 seconds	10 weeks postoperative	No
Secondary	Stair test	The time taken to ascend 18 steps as fast as possible	10 weeks postoperative	No
Secondary	Hip Osteoarthritis Outcome Score (HOOS)	Questionnaire. A disease-specific patient reported outcome measure of function, pain, sport/recreation and quality of life related to the hip.	6 months postoperative	No
Secondary	Walking speed	Maximal walking speed measured over 20 m.	10 weeks	No
Secondary	Walking speed	Maximal walking speed measured over 20 m.	6 months postoperative	No
Secondary	Leg extension power	The power in leg extension is measured using the Nottingham leg extension power rig. Data is provided in watt and adjusted for bodyweight (watt/kg)	6 months postoperative	No
Secondary	Sit-to-stand	The maximal number of rises from a chair within 30 seconds	6 months postoperative	No
Secondary	Stair test	The time taken to ascend 18 steps as fast as possible	6 months postoperative	No
Secondary	Hip Osteoarthritis Outcome Score (HOOS)	Questionnaire. A disease-specific patient reported outcome measure of function, pain, sport/recreation and quality of life related to the hip.	2 weeks postoperative	No
Secondary	Hip Osteoarthritis Outcome Score (HOOS)	Questionnaire. A disease-specific patient reported outcome measure of function, pain, sport/recreation and quality of life related to the hip.	4 weeks postoperative	No
Secondary	Hip Osteoarthritis Outcome Score (HOOS)	Questionnaire. A disease-specific patient reported outcome measure of function, pain, sport/recreation and quality of life related to the hip.	6 weeks postoperative	No
Secondary	Isometric muscle strength	Test of isometric muscle strength in hip abduction and hip flexion using hand-held dynamometry	4 weeks postoperative	No
Secondary	Isometric muscle strength	Test of isometric muscle strength in hip abduction and hip flexion using hand-held dynamometry	10 weeks postoperative	No
Secondary	Isometric muscle strength	Test of isometric muscle strength in hip abduction and hip flexion using hand-held dynamometry	6 months postoperative	No
Secondary	Gait quality	Instrumented gait analysis using a combined accelerometer and gyro-sensor in 20 meter walk test and stair climb test. The purpose is to measure asymmetry between limps during walking and stair climbing and compare the two groups according to these variables. This outcome measure is performed on a subgroup of participants (n=26, 13 in each group)	10 weeks postoperative	No
Secondary	Gait quality	Instrumented gait analysis using a combined accelerometer and gyro-sensor in 20 meter walk test and stair climb test. The purpose is to measure asymmetry between limps during walking and stair climbing and compare the two groups according to these variables. This outcome measure is performed on a subgroup of participants (n=26, 13 in each group)	6 months postoperative	No
Secondary	Hip Osteoarthritis Outcome Score (HOOS)	Questionnaire. A disease-specific patient reported outcome measure of function, pain, sport/recreation and quality of life related to the hip.	10 weeks postoperative	No
Secondary	Hip Osteoarthritis Outcome Score (HOOS)	Questionnaire. A disease-specific patient reported outcome measure of function, pain, sport/recreation and quality of life related to the hip.	1 year postoperative	No