- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05375565
Comparative Effects of Weight Bearing and Non-weight Bearing Exercises in Patients With Total Hip Replacement
December 17, 2022 updated by: Riphah International University
Comparative Effects of Weight Bearing and Non-weight Bearing Exercises on Pain, Range of Motion and Disability in Patients With Total Hip Replacement
to compare the effects of weight bearing and non-weight bearing exercises on pain, range of motion and disability in patients with total hip replacement
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 64000
- Lahore general hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
33 years to 58 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- unilateral total hip arthroplasty
- posterolateral approach of hip replacement
- patients that were willing to participate
- patients with 2 weeks post-operative history of total hip replacement
Exclusion Criteria:
- History of any systemic pathology
- Individual suffering from congenital hip disease.
- Bilateral total hip arthroplasty
- Evidence of CNS involvement and any other neurological involvement
- Any red flag (malignancies or any kind of tumor
- History of lower extremity fracture.
- Patient having any local or systemic infection of hip joint
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: weight bearing exercises
|
The session will be around 45 to 60 minutes on each patient with 2 sessions per week on alternate days to observe the long term effects. |
Experimental: non weight bearing exercises
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric pain rating scale (NPRS)
Time Frame: 6 weeks
|
NPRS is anchored by terms describing pain severity extremes.
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g.
"no pain") to '10' representing the other pain extreme (e.g.
"pain as bad as you can imagine" or "worst pain imaginable"
|
6 weeks
|
Goniometry
Time Frame: 6 weeks
|
A goniometer is a device that measures an angle or permits the rotation of an object to a definite position
|
6 weeks
|
Hip disability and Osteoarthritis Outcome Score (HOOS)
Time Frame: 6 weeks
|
A 40 item questionnaire (hip disability and osteoarthritis outcome score, HOOS) was constructed to assess patient-relevant outcomes in five separate subscales (pain, symptoms, activity of daily living, sport and recreation function and hip related quality of life).
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: hina gul, t-DPT, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Goh SL, Persson MSM, Stocks J, Hou Y, Welton NJ, Lin J, Hall MC, Doherty M, Zhang W. Relative Efficacy of Different Exercises for Pain, Function, Performance and Quality of Life in Knee and Hip Osteoarthritis: Systematic Review and Network Meta-Analysis. Sports Med. 2019 May;49(5):743-761. doi: 10.1007/s40279-019-01082-0.
- Wijnen A, Bouma SE, Seeber GH, van der Woude LHV, Bulstra SK, Lazovic D, Stevens M, van den Akker-Scheek I. The therapeutic validity and effectiveness of physiotherapeutic exercise following total hip arthroplasty for osteoarthritis: A systematic review. PLoS One. 2018 Mar 16;13(3):e0194517. doi: 10.1371/journal.pone.0194517. eCollection 2018.
- Pozzi F, Madara K, Zeni JA Jr. A SIX-WEEK SUPERVISED EXERCISE AND EDUCATIONAL INTERVENTION AFTER TOTAL HIP ARTHROPLASTY: A CASE SERIES. Int J Sports Phys Ther. 2017 Apr;12(2):259-272.
- Mikkelsen LR, Madsen MN, Rathleff MS, Thorborg K, Rossen CB, Kallemose T, Bandholm T. Pragmatic Home-Based Exercise after Total Hip Arthroplasty - Silkeborg: Protocol for a prospective cohort study (PHETHAS-1). F1000Res. 2019 Jun 25;8:965. doi: 10.12688/f1000research.19570.2. eCollection 2019.
- Wu JQ, Mao LB, Wu J. Efficacy of exercise for improving functional outcomes for patients undergoing total hip arthroplasty: A meta-analysis. Medicine (Baltimore). 2019 Mar;98(10):e14591. doi: 10.1097/MD.0000000000014591.
- Monaghan B, Cunningham P, Harrington P, Hing W, Blake C, O' Dohertya D, Cusack T. Randomised controlled trial to evaluate a physiotherapy-led functional exercise programme after total hip replacement. Physiotherapy. 2017 Sep;103(3):283-288. doi: 10.1016/j.physio.2016.01.003. Epub 2016 Feb 15.
- Bandholm T, Wainwright TW, Kehlet H. Rehabilitation strategies for optimisation of functional recovery after major joint replacement. J Exp Orthop. 2018 Oct 11;5(1):44. doi: 10.1186/s40634-018-0156-2.
- Ackerman IN, Bohensky MA, Zomer E, Tacey M, Gorelik A, Brand CA, de Steiger R. The projected burden of primary total knee and hip replacement for osteoarthritis in Australia to the year 2030. BMC Musculoskelet Disord. 2019 Feb 23;20(1):90. doi: 10.1186/s12891-019-2411-9.
- Patel S, Bhanushali Y, Gadhavi B. Effect of Following Physiotherapy on Strength and Range of Motion in Patients with Total Hip Arthroplasty: A Case Series. International Journal of Health Sciences and Research. 2021;11(4):122-32.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2021
Primary Completion (Actual)
July 31, 2022
Study Completion (Actual)
July 31, 2022
Study Registration Dates
First Submitted
April 26, 2022
First Submitted That Met QC Criteria
May 10, 2022
First Posted (Actual)
May 16, 2022
Study Record Updates
Last Update Posted (Actual)
December 20, 2022
Last Update Submitted That Met QC Criteria
December 17, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- REC/Lhr/22/0140 Habiba
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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