NCT03798002

Brief Summary

A randomized controlled trial in which Neuro-muscular exercise training and Isolated quadriceps training program would be applied on patients with symptomatic knee Osteoarthritis by using different tools and changes would be examined pre and post intervention .The participants fulfilling inclusion criteria would be randomly allocated to two groups. Both groups received different protocols and will be assessed on data collection tool on their first and last visit by using Numeric Pain Rating Scale (NPRS), The Western Ontario and McMaster Osteoarthritis Index (WOMAC), Timed Up and Go test (TUG test), 30sec chair stand test,6min walk test (6MWT).Participants of both groups will be pre-tested before the application of interventional programs and post-tested after the application of respective intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

January 5, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 9, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

January 15, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

August 8, 2019

Status Verified

August 1, 2019

Enrollment Period

4 months

First QC Date

January 5, 2019

Last Update Submit

August 7, 2019

Conditions

Keywords

isolated quadriceps trainingNeuro-muscular exercise trainingknee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • WOMAC Scale

    WOMAC is western Onterio and McMaster Osteoarthritis Index. Its scores are from 0-100

    From baseline to 8th week

Secondary Outcomes (1)

  • Numeric pain rating scale(NPRS)

    From baseline to 8th week

Study Arms (2)

Neuro-muscular exercise training Group

EXPERIMENTAL

Neuro-muscular exercise training will be administer to Knee OA patients.

Other: Neuro-muscular exercise training Group

quadriceps training program

ACTIVE COMPARATOR

quadriceps stretching and strengthening exercises will be administer to Knee OA patients.

Other: quadriceps training program

Interventions

Training takes place 3 days a week for 8 weeks follow up, under the supervision of physical therapist A training session lasts for 40 minutes, and consists of three parts. PART 1:Warming up: warm-up period consists of ergometer cycling for 10 minutes PART 2: Circuit program: comprises four exercises, core stability/postural function; postural orientation; lower extremity muscle strength; and functional exercises. Each exercise is performed 2-3 sets 10-15 repetitions. PART 3:Cooling down: The cooling down part consists of walking exercises forward and backwards, about 10 meters in each direction, in front of mirror (mobility exercises for the lower extremity muscles for a total of about 10 minutes. Changes in patient's symptom assessed by structural questionnaire

Neuro-muscular exercise training Group

Apply Tens (10min+ hot pack 7-10min) Before excercise ROM,Quadriceps and hamstring stretching exercise's and strengthening exercises. 4th-6th week (in addition): Straight leg raise, Quads over a roll, Hamstring curls. 7th and 8th week (in addition): Elastic band exercise, Hamstring curls, Quads chair, isometric strengthening All exercises are performed in set of 10 repetitions. 1 set of all exercises was twice a day for first 3 week, and 2 sets twice a day until 6th week and then 3 sets twice a day until 8th week

quadriceps training program

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • UL/BL knee OA,
  • Age 40-65, both genders,
  • American college of rheumatology criteria for knee OA,
  • Grade 2 or 3 on Kellgren/Lawrence classification for Knee OA.

You may not qualify if:

  • Knee surgery
  • Rheumatoid arthritis
  • Any neurological condition affecting lower limbs and balance
  • Use of assistive devices for walking.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Imran Amjad

Islamabad, Punjab Province, 46000, Pakistan

Location

Riphah International University

Islamabad, 46000, Pakistan

Location

Related Publications (8)

  • Weng MC, Lee CL, Chen CH, Hsu JJ, Lee WD, Huang MH, Chen TW. Effects of different stretching techniques on the outcomes of isokinetic exercise in patients with knee osteoarthritis. Kaohsiung J Med Sci. 2009 Jun;25(6):306-15. doi: 10.1016/S1607-551X(09)70521-2.

    PMID: 19560995BACKGROUND
  • Slemenda C, Brandt KD, Heilman DK, Mazzuca S, Braunstein EM, Katz BP, Wolinsky FD. Quadriceps weakness and osteoarthritis of the knee. Ann Intern Med. 1997 Jul 15;127(2):97-104. doi: 10.7326/0003-4819-127-2-199707150-00001.

    PMID: 9230035BACKGROUND
  • 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.

    PMID: 23559821BACKGROUND
  • Merashly M, Uthman I. Management of knee osteoarthritis: an evidence-based review of treatment options. J Med Liban. 2012 Oct-Dec;60(4):237-42.

    PMID: 23461090BACKGROUND
  • Holsgaard-Larsen A, Clausen B, Sondergaard J, Christensen R, Andriacchi TP, Roos EM. The effect of instruction in analgesic use compared with neuromuscular exercise on knee-joint load in patients with knee osteoarthritis: a randomized, single-blind, controlled trial. Osteoarthritis Cartilage. 2017 Apr;25(4):470-480. doi: 10.1016/j.joca.2016.10.022. Epub 2016 Nov 9.

    PMID: 27836677BACKGROUND
  • Villadsen A, Overgaard S, Holsgaard-Larsen A, Christensen R, Roos EM. Immediate efficacy of neuromuscular exercise in patients with severe osteoarthritis of the hip or knee: a secondary analysis from a randomized controlled trial. J Rheumatol. 2014 Jul;41(7):1385-94. doi: 10.3899/jrheum.130642. Epub 2014 Jun 15.

    PMID: 24931956BACKGROUND
  • Ageberg E, Nilsdotter A, Kosek E, Roos EM. Effects of neuromuscular training (NEMEX-TJR) on patient-reported outcomes and physical function in severe primary hip or knee osteoarthritis: a controlled before-and-after study. BMC Musculoskelet Disord. 2013 Aug 8;14:232. doi: 10.1186/1471-2474-14-232.

    PMID: 23924144BACKGROUND
  • Bennell KL, Egerton T, Wrigley TV, Hodges PW, Hunt M, Roos EM, Kyriakides M, Metcalf B, Forbes A, Ageberg E, Hinman RS. Comparison of neuromuscular and quadriceps strengthening exercise in the treatment of varus malaligned knees with medial knee osteoarthritis: a randomised controlled trial protocol. BMC Musculoskelet Disord. 2011 Dec 5;12:276. doi: 10.1186/1471-2474-12-276.

    PMID: 22141334BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • imran Amjad, Phd*

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2019

First Posted

January 9, 2019

Study Start

January 15, 2019

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

August 8, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations