NCT05375565

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 16, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

December 20, 2022

Status Verified

December 1, 2022

Enrollment Period

10 months

First QC Date

April 26, 2022

Last Update Submit

December 17, 2022

Conditions

Keywords

weight bearingexercisehippainreplacementarthroplastyrange of motion

Outcome Measures

Primary Outcomes (3)

  • 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"

    6 weeks

  • Goniometry

    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)

    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

Study Arms (2)

weight bearing exercises

EXPERIMENTAL

weight bearing exercises

Other: weight bearing exercises

non weight bearing exercises

EXPERIMENTAL

non weight bearing exercises

Other: non weight bearing exercises

Interventions

* 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.

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.

non weight bearing exercises

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lahore General hospital

Lahore, Punjab Province, 64000, Pakistan

Location

Related Publications (9)

  • 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.

    PMID: 29547670BACKGROUND
  • 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.

    PMID: 28515981BACKGROUND
  • 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.

    PMID: 31448107BACKGROUND
  • 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.

    PMID: 30855443BACKGROUND
  • 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.

    PMID: 27126617BACKGROUND
  • 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.

    PMID: 30830561BACKGROUND
  • 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.

    PMID: 30306337BACKGROUND
  • 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.

    PMID: 30797228BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Motor ActivityPain

Condition Hierarchy (Ancestors)

BehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • hina gul, t-DPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2022

First Posted

May 16, 2022

Study Start

October 1, 2021

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

December 20, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations