Exercises in the Post-operative Rehabilitation of THA
Primary Purpose
Hip Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Rehabilitation exercises
Postoperative guidance
Sponsored by
About this trial
This is an interventional treatment trial for Hip Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Referred by orthopedic doctors of the city of Porto Alegre, Rio Grande do Sul, Brazil;
- Between 30-60 days of unilateral total hip arthroplasty (cemented and hybrid prostheses) postoperative phase;
- Read and consent to the Free and Informed Consent Form and understood the guidelines necessary to carry out the evaluations proposed in this research.
Exclusion Criteria:
- Performing a surgical procedure, in the last six months, in other articular joints in the lower limbs;
- previous surgical procedures in the coxofemoral joint;
- surgical procedures and osteoarticular diseases in the lumbar spine;
- osteoarticular diseases in lower limb joints;
- muscle injuries in lower limbs;
- presence of signs or symptoms of osteoarthritis in the contralateral hip;
- postoperative complications such as prosthesis dislocation, deep venous thrombosis, periarticular fractures and neural lesions;
- intra-articular injection of corticosteroids in the lower limbs during the last six months;
- cardiovascular diseases with presence of disability, such as severe dyspnea and uncontrolled arterial hypertension;
- presence of neurological diseases.
Sites / Locations
- Federal Health Science University of Porto AlegreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
Rehabilitation Exercises Group 1 will be submitted to an exercise protocol based on muscle strength training, with duration of 6 weeks and frequency of two weekly sessions, lasting 45 minutes.
Postoperative guidance Group 2 will receive an orientation booklet and weekly links from researchers to address possible questions.
Outcomes
Primary Outcome Measures
6 Weeks Post-Intervention Muscle Strength
Muscle strength will be measured by a portable dynamometer and represented as muscle torque (N.m).
Secondary Outcome Measures
Functional Capacity (TUG)
Functional capacity will be evaluated through the timed up and go test.
Functional Capacity (HHS)
Functional capacity will be evaluated through the harris hip score questionnaire.
Hip Range of Motion
Hip range of motion will be measured with a flexometer and presented in degrees of movement.
Pain in the operated hip (last seven days)
The patient will be asked about pain felt in the operated hip within the last 7 days. Pain will be assessed with the numeric pain scale and will be represented by the number selected by the patient.
1 Week Post-Intervention Muscle Strength
Muscle strength will be measured by a portable dynamometer and represented as muscle torque (N.m).
Pre-Intervention Muscle Strength
Muscle strength will be measured by a portable dynamometer and represented as muscle torque (N.m)
Full Information
NCT ID
NCT03208829
First Posted
July 1, 2017
Last Updated
April 4, 2020
Sponsor
Federal University of Health Science of Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT03208829
Brief Title
Exercises in the Post-operative Rehabilitation of THA
Official Title
Effects of an Exercise Program Based on Muscle Strengthening in the Rehabilitation of Individuals Undergoing Total Hip Arthroplasty: a Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 4, 2018 (Actual)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Health Science of Porto Alegre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Subjects submitted to unilateral THA will be randomized into two rehabilitation groups. One group will receive a booklet with guidelines for postoperative care, while the other group will participate in face-to-face sessions with exercises with emphasis on muscle strengthening.
Detailed Description
Individuals with osteoarthritis (OA) of the hip submitted to total hip arthroplasty (THA) may present alterations in their functional capacity, and associated, among other aspects, the reduction in muscle strength. Our overall objective is to compare the effects of an exercise program based on training of muscular strength to orientations and functional home exercises in patients submitted to THA, as well as to compare the outcomes of both groups with those of healthy individuals. Individuals with THA will be randomly assigned to two groups. One group will receive face-to-face treatment (G1) and the other will receive postoperative guidance (G2). A blinded appraiser regarding the allocation will apply the evaluation tools at the moments: preintervention, after completing 7 days and after 10 weeks of the end of the treatment. The research will present as clinical outcomes: the muscular strength, through the values of torque peaks obtained in dynamometry; the functional capacity through the results of the Timed Up and Go test and the Harris Hip Score questionnaire; the range of joint motion measured with and flexometer; the pain through the results of the numerical scale of pain; and kinesiophobia, through the scores obtained in the Tampa Scale.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients with total hip arthroplasty, will be assigned to two different treatment groups.
Masking
ParticipantOutcomes Assessor
Masking Description
The random allocation step will be conducted through Randomizers - www.random.org by a research assistant. The assistant responsible for randomization will not be involved in any other phase of the study and the secrecy of the allocation will be maintained through opaque envelopes. A second independent assistant will administer the agenda and all communication between the participants and the researchers involved
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Rehabilitation Exercises Group 1 will be submitted to an exercise protocol based on muscle strength training, with duration of 6 weeks and frequency of two weekly sessions, lasting 45 minutes.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Postoperative guidance Group 2 will receive an orientation booklet and weekly links from researchers to address possible questions.
Intervention Type
Other
Intervention Name(s)
Rehabilitation exercises
Intervention Description
Patients in group 1 will participate in a physical exercise protocol supervised by a physiotherapist. The sessions will focus on the rehabilitation of muscle strength and the exercises will be performed with increased external load.
Intervention Type
Other
Intervention Name(s)
Postoperative guidance
Intervention Description
Group 2 will receive only guidelines regarding postoperative care.
Primary Outcome Measure Information:
Title
6 Weeks Post-Intervention Muscle Strength
Description
Muscle strength will be measured by a portable dynamometer and represented as muscle torque (N.m).
Time Frame
Will be measured post intervention 6 weeks after intervention).
Secondary Outcome Measure Information:
Title
Functional Capacity (TUG)
Description
Functional capacity will be evaluated through the timed up and go test.
Time Frame
Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
Title
Functional Capacity (HHS)
Description
Functional capacity will be evaluated through the harris hip score questionnaire.
Time Frame
Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
Title
Hip Range of Motion
Description
Hip range of motion will be measured with a flexometer and presented in degrees of movement.
Time Frame
Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
Title
Pain in the operated hip (last seven days)
Description
The patient will be asked about pain felt in the operated hip within the last 7 days. Pain will be assessed with the numeric pain scale and will be represented by the number selected by the patient.
Time Frame
Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
Title
1 Week Post-Intervention Muscle Strength
Description
Muscle strength will be measured by a portable dynamometer and represented as muscle torque (N.m).
Time Frame
Will be measured post intervention (1 week after intervention).
Title
Pre-Intervention Muscle Strength
Description
Muscle strength will be measured by a portable dynamometer and represented as muscle torque (N.m)
Time Frame
Will be measured pre-intervention (30 days after the surgery).
Other Pre-specified Outcome Measures:
Title
Body Mass Index
Description
Body mass index will be acquired by measuring weight and height, and presented in form of the equation mass/height².
Time Frame
Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
Title
Length of Lower Limbs
Description
Length of lower limbs will be performed through a tape measure and presented in centimeters.
Time Frame
Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
Title
Kinesiophobia
Description
For the evaluation of the kinesiophobia will be used the Tampa Scale.
Time Frame
Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
Title
Femoral Offset
Description
Evaluation of femoral vertical and horizontal offset, using radiography exams.
Time Frame
Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Referred by orthopedic doctors of the city of Porto Alegre, Rio Grande do Sul, Brazil;
Between 30-60 days of unilateral total hip arthroplasty (cemented and hybrid prostheses) postoperative phase;
Read and consent to the Free and Informed Consent Form and understood the guidelines necessary to carry out the evaluations proposed in this research.
Exclusion Criteria:
Performing a surgical procedure, in the last six months, in other articular joints in the lower limbs;
previous surgical procedures in the coxofemoral joint;
surgical procedures and osteoarticular diseases in the lumbar spine;
osteoarticular diseases in lower limb joints;
muscle injuries in lower limbs;
presence of signs or symptoms of osteoarthritis in the contralateral hip;
postoperative complications such as prosthesis dislocation, deep venous thrombosis, periarticular fractures and neural lesions;
intra-articular injection of corticosteroids in the lower limbs during the last six months;
cardiovascular diseases with presence of disability, such as severe dyspnea and uncontrolled arterial hypertension;
presence of neurological diseases.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruna M Lopes, PhD Student
Phone
+5551993276096
Email
blopes.fisio@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marcelo F Silva, PhD
Email
marcelofs@ufcspa.edu.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruna M Lopes, PhD Student
Organizational Affiliation
Federal Health Science University of Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal Health Science University of Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90050-170
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcelo F Silva, PhD
Email
marcelofs@ufcspa.edu.br
First Name & Middle Initial & Last Name & Degree
Bruno M Baroni, PhD
Email
bruno.baroni@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Bruna M Lopes, PhD student
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Exercises in the Post-operative Rehabilitation of THA
We'll reach out to this number within 24 hrs