Total Hip ReplacementNCT05375565
Comparative Effects of Weight Bearing and Non-weight Bearing Exercises in Patients With Total Hip Replacement
A study testing weight bearing exercises and non weight bearing exercises in people with Total Hip Replacement, run by Riphah International University at 1 site in Pakistan.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Total Hip Replacement
- What is being tested?
- weight bearing exercises and non weight bearing exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2021to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Total Hip Replacement
- Being tested
- weight bearing exercises, non weight bearing exercises
- Keywords
- weight bearing, exercise, hip, pain, replacement, arthroplasty, range of motion
- Medical subject headings
- Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weight bearing exercisesOther
- Standing knee raise 10 rep x 2sets
- Standing knee bend 10 rep x 2sets
- Standing hip extension 10 rep x 2sets
- Shallow squats 5 rep x 2 sets After 4 week gradually restricting the use of assistive device when patient become able to walk and stand for 10 mins then add stair climbing and descending with a step height not higher than 7 inch.
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.
non weight bearing exercisesOther
- Seated knee flexion 10 rep x 2sets
- Seated knee extension 10 rep x2sets
- Use of stationary bicycle 10 mins
- Side lying leg lift 10 rep x2sets
- Straight leg raise 10 rep x 2sets 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.
| Study group | Role | What they receive |
|---|---|---|
| weight bearing exercises | Experimental | weight bearing exercises Receives: Other: weight bearing exercises |
| non weight bearing exercises | Experimental | non weight bearing exercises Receives: Other: non weight bearing exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale (NPRS)
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"
Measured: 6 weeks
Goniometry
A goniometer is a device that measures an angle or permits the rotation of an object to a definite position
Measured: 6 weeks
Hip disability and Osteoarthritis Outcome Score (HOOS)
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).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start1 Oct 2021
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Total Hip ReplacementStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- hina gul, t-DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05375565
- Sponsor's protocol ID
- REC/Lhr/22/0140 Habiba
- Status last verified
- Dec 2022
- First submitted
- 26 Apr 2022
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29547670Pozzi 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.
PubMed 28515981Mikkelsen 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.
PubMed 31448107Wu 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.
PubMed 30855443Monaghan 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.
PubMed 27126617Goh 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.
PubMed 30830561Bandholm 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.
PubMed 30306337Ackerman 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.
PubMed 30797228Patel 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 at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Weight Bearing and Non-weight Bearing Exercises on Pain, Range of Motion and Disability in Patients With Total Hip Replacement
- ClinicalTrials.gov ID
- NCT05375565
- Acronym / sponsor ID
- REC/Lhr/22/0140 Habiba
- Conditions
- Total Hip Replacement
- Keywords
- weight bearing, exercise, hip, pain, replacement, arthroplasty, range of motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 16 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| weight bearing exercises | Experimental | Other: weight bearing exercisesweight bearing exercises |
| non weight bearing exercises | Experimental | Other: non weight bearing exercisesnon weight bearing exercises |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| weight bearing exercises* Standing knee raise 10 rep x 2sets * Standing knee bend 10 rep x 2sets * Standing hip extension 10 rep x 2sets * Shallow squats 5 rep x 2 sets After 4 week gradually restricting the use of assistive device when patient become able to walk and stand for 10 mins then add stair climbing and descending with a step height not higher than 7 inch. 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. | Other | weight bearing exercises |
| non weight bearing exercises* Seated knee flexion 10 rep x 2sets * Seated knee extension 10 rep x2sets * Use of stationary bicycle 10 mins * Side lying leg lift 10 rep x2sets * Straight leg raise 10 rep x 2sets 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. | Other | non weight bearing exercises |
Primary outcome
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"
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
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Background: PubMed 29547670Wijnen 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.
- Background: PubMed 28515981Pozzi 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.
- Background: PubMed 31448107Mikkelsen 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.
- Background: PubMed 30855443Wu 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.
- Background: PubMed 27126617Monaghan 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.
- Background: PubMed 30830561Goh 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.
- Background: PubMed 30306337Bandholm 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.
- Background: PubMed 30797228Ackerman 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.
- BackgroundPatel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hina gul, t-DPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing weight bearing exercises and non weight bearing exercises in people with Total Hip Replacement, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric pain rating scale (NPRS) (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05375565, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.