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Knee OsteoarthritisNCT05131048

Home Based Hip Strengthening for Knee OA Patients

A study testing conventional group and experimental group in people with Knee Osteoarthritis, run by University of Lahore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In knee osteoarthritis patients, weakness of hip abductor muscles is considered an important contributing factor leading to the progression of the disease. Read more about this study

Who is it for?
Ages 40 to 60 years
Conditions the study is for
Knee Osteoarthritis
What is being tested?
conventional group and experimental group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
No sites listed yet
Study dates
Nov 2021to Jan 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 40 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • The age group was from 40 to 60 years.
  • Both males and females were included.
  • Average knee pain on walking >3 on an 11-point scale (NPRS) (0 no pain; 10 maximal pain).
  • participants can walk independently without any assistive devices
  • Diagnosed patients of grade II \& III of Kallgren and Lawrence scale for knee osteoarthritis referred by an orthopaedic surgeon

Who cannot join

  • History of osteoporosis.
  • Leg length discrepancy or structural deformity
  • Knee surgery or TKR.
  • Corticosteroid injection in knee joint
  • Systemic arthritic condition
  • History of tibiofemoral and patellofemoral replacement
  • Any other neurological and muscular condition affecting the lower limb
  • Any history of radiculopathy.

Trial locations and contacts

No sites are listed yet.

faizan asghar contact

00923237018937

faianasghar@gmail.com

About this study

Official title: Effects of Home-based Hip Strengthening Exercises on Pain, Range of Motion and Functional Disability in Knee Osteoarthritis Patients: a Randomized Controlled Trial

In knee osteoarthritis patients, weakness of hip abductor muscles is considered an important contributing factor leading to the progression of the disease.

Read the detailed description

Osteoarthritis is the most common type of disease that results from an abnormality in joint function. Osteoarthritis(OA) is a condition that is characterized by progressive loss of articular cartilage of a joint and causes pain. Yamda et al. found that the strength of hip adductors increases with the severity of the disease. This reflects that more use of these muscles lower knee adductor moment 54. Considering this research, knee loads can be altered by strengthening hip muscles. Pakistan is listed in 3rd world countries and the poverty index is high. Many patients show reluctance in going to clinics for the physiotherapeutic management of knee OA. So, the present research intends to investigate the effects of home-based hip strengthening exercise on pain, functions, and range of motion in elderly knee osteoarthritis patients.

Being tested
conventional group, experimental group
Keywords
osteoarthritis, home-based exercise plan, functional disability, obesity
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • conventional groupOther

    this group will perform conventional therapy

  • experimental groupOther

    this group will perform home based exercises

Study groups in NCT05131048
Study groupRoleWhat they receive
Conventional groupActive comparatorPatients will be given thermal therapy with the hot pack for 20 minutes followed by Conventional physiotherapy will consist of a set of exercises. The exercise components willl be chosen based on previous studies (Deyle 2000) and will comprises of * stretches of lower limb muscles (gastrocnemius, soleus and hamstring) * isometric quadriceps work * straight leg raising * Joint mobilization includes anteroposterior (AP) glide of the tibia on the femur * the patella glides in all directions Subjects will participate in a 45-minute physical therapy session, on alternate days weekly for 6 weeks, in our centre under the close surveillance of a physical therapist. A total of 24 sessions will be given to this group.
Receives: Other: conventional group
interventional groupExperimentalPatients in this group will perform home-based hip Strengthening exercises to strengthen hip abductor and adductor muscles. Six different home-based exercises will be taught. This group will have 3 sessions in 1st week in the hospital under the supervision of a trained physiotherapist just to teach them and ensure that patients are doing exercises correctly on their own. After that, patients will perform exercises 5 days at home and 1 session at the hospital per week. The therapist will be trained to deliver different exercises and adjust the intensity of exercise accordingly advise the participants to complete 10 repetitions of every exercise at home96. * Abduction in side-lying * Abduction in standing * Standing wall isometric hip abduction * Hip Adduction in side-lying * Hip abduction in a standing position * Towel press
Receives: Other: experimental group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. intensity of Pain

    The numerical Pain Rating Scale will be used to measure pain.

    Measured: baseline data

  2. intensity of Pain

    The numerical Pain Rating Scale will be used to measure pain.

    Measured: at the end of 6th week

  3. Range of Motion

    A goniometer will be used to measure a range of motion.

    Measured: baseline data

  4. Range of Motion

    A goniometer will be used to measure a range of motion.

    Measured: at the end of 6th week

  5. Functional Disability

    KOOS Scale will be used to measure functional disability.

    Measured: baseline data

  6. Functional Disability

    KOOS Scale will be used to measure functional disability.

    Measured: at the end of 6th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2021
  2. Study startNov 2021 (estimated)
  3. Primary completionDec 2021 (estimated)
  4. Study completionJan 2022 (estimated)

Resources

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
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05131048
Sponsor's protocol ID
890-V
Status last verified
Nov 2021
First submitted
11 Nov 2021
Last updated
23 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Valdes AM, McWilliams D, Arden NK, Doherty SA, Wheeler M, Muir KR, Zhang W, Cooper C, Maciewicz RA, Doherty M. Involvement of different risk factors in clinically severe large joint osteoarthritis according to the presence of hand interphalangeal nodes. Arthritis Rheum. 2010 Sep;62(9):2688-95. doi: 10.1002/art.27574.

    PubMed 20499385

  • Blagojevic M, Jinks C, Jeffery A, Jordan KP. Risk factors for onset of osteoarthritis of the knee in older adults: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2010 Jan;18(1):24-33. doi: 10.1016/j.joca.2009.08.010. Epub 2009 Sep 2.

    PubMed 19751691

  • Fatima S, Arslan SA, Sharif F, Ahmad A, Gillani SA, Zaheer A. Translation, cross-cultural adaptation and psychometric properties of the Urdu version of knee injury and osteoarthritis outcome score questionnaire for Pakistani population. BMC Musculoskelet Disord. 2021 Jun 26;22(1):592. doi: 10.1186/s12891-021-04477-1.

    PubMed 34174864

  • Bhatia D, Bejarano T, Novo M. Current interventions in the management of knee osteoarthritis. J Pharm Bioallied Sci. 2013 Jan;5(1):30-8. doi: 10.4103/0975-7406.106561.

    PubMed 23559821

  • Farrokhi S, Voycheck CA, Tashman S, Fitzgerald GK. A biomechanical perspective on physical therapy management of knee osteoarthritis. J Orthop Sports Phys Ther. 2013 Sep;43(9):600-19. doi: 10.2519/jospt.2013.4121.

    PubMed 23756435

  • Safran-Norton CE, Sullivan JK, Irrgang JJ, Kerman HM, Bennell KL, Calabrese G, Dechaves L, Deluca B, Gil AB, Kale M, Luc-Harkey B, Selzer F, Sople D, Tonsoline P, Losina E, Katz JN. A consensus-based process identifying physical therapy and exercise treatments for patients with degenerative meniscal tears and knee OA: the TeMPO physical therapy interventions and home exercise program. BMC Musculoskelet Disord. 2019 Nov 4;20(1):514. doi: 10.1186/s12891-019-2872-x.

    PubMed 31684921

  • Arhos EK, Thoma LM, Grindem H, Logerstedt D, Risberg MA, Snyder-Mackler L. Association of Quadriceps Strength Symmetry and Surgical Status With Clinical Osteoarthritis Five Years After Anterior Cruciate Ligament Rupture. Arthritis Care Res (Hoboken). 2022 Mar;74(3):386-391. doi: 10.1002/acr.24479. Epub 2022 Jan 19.

    PubMed 33026698

Questions about this trial

What is this clinical trial studying?

A study testing conventional group and experimental group in people with Knee Osteoarthritis, run by University of Lahore.

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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact faizan asghar (00923237018937, faianasghar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

intensity of Pain (time frame: baseline data). The study lists 6 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 NCT05131048, which also lists 7 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 23 Nov 2021.

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