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Knee OsteoarthritisNCT03798002

Neuro-muscular Exercise Training Verses Quadriceps Training in Mild to Moderate Knee Osteoarthritis

A study testing Neuro-muscular exercise training Group and quadriceps training program in people with Knee Osteoarthritis, run by Riphah International University at 2 sites in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 65 years
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Neuro-muscular exercise training Group and quadriceps training program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesPakistan
Study dates
15 Jan 2019to 30 Apr 2019
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Pakistan2 sites
  • Imran Amjad

    Islamabad, Punjab Province, 46000

  • Riphah International University

    Islamabad, 46000

Other trials in Pakistan

About this study

Official title: Effects of Neuro-muscular Exercise Training Verses Isolated Quadriceps Training Program in Patients With Mild to Moderate Knee Osteoarthritis

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.

Read the detailed description

The knee joint is a complex modified hinge joint with the greatest range of movement. Three bones come together to form the joint, which are the femur, tibia, and patella. Osteoarthritis, commonly known as wear-and-tear arthritis, is a condition in which the natural cushioning between joints, cartilage wears away. The bones of the joints rub more closely against one another with less of the shock-absorbing benefits of cartilage. The rubbing results in pain, swelling, stiffness, decreased ability to move and, sometimes, the formation of bone spurs.

Osteoarthritis is widespread among physically active individuals . The quadriceps weakness commonly associated with osteoarthritis of the knee is widely believed to result from disuse atrophy secondary to pain in the involved joint. However, quadriceps weakness may be an etiologic factor in the development of osteoarthritis. Several studies have indicated that Physical modalities for the treatment of knee pain in patients with osteoarthritis include physical therapy, exercise, weight loss, and the use of braces or heel wedges. High- and low-intensity aerobic exercises are equally effective in improving functional status, gait, pain, and aerobic capacity in persons with knee osteoarthritis water-based and land-based exercises reduce knee pain and physical disability and aerobic walking, quadriceps strengthening, resistance exercise reduce pain and disability.Several proptocols are available for management of knee joint osteoarthritis. These protocols include Neuro motor training exercise and isolated quadriceps training program. Neuromotor training is basically combination of three parts warming up, a circuit program, and cooling down. Main principle of Neuro-motor training is to improve sensorimotor control and compensatory functional stability.[3]Patients with symptomatic osteoarthritis pain, stiffness, flexibility and decreases range of motion is a common clinical finding. Flexibility is an important component of fitness needed for most desirable musculoskeletal functioning and maximizing the performance of physical activities. Flexibility is a biomechanical property of the body tissues and it determines the range of motion possible without injury at a joint or group of joints. Decrease range of motion has been shown to predispose a person to several musculoskeletal overuse injuries and considerably affect a person level of function.Changes in joint appearance/ joint deformities be one of the more commonly established causes of osteoarthritis. The target in treating patients with OA should be the safest possible intervention, with the best pain relief and prevention of further functional disability. Neuromotor training is also one of the treatment option related to physical therapy in reducing knee pain with home plane exercises to gain required ROM and resume function. Time up and go test (TUG test).the tug is internationally accepted functional dynamic test of balance with known reliability and validity as well as being low cost and easy to apply. The tug test measures the time in seconds that takes a subject to stand up from chair and sit down. Subject will score less than 10 seconds are consider normal, less than 15 sec are at risk of fall ,less than 20 sec are independent in ambulation and able to climb the stairs, and greater than 30 seconds need help with chair. The 30 Second Chair Stand Test, in conjunction with other measures such as the 4-Stage Balance Test, Timed Up and Go (TUG) Test and an assessment of postural hypotension can help to indicate if a patient is at risk of falling. Purpose is to test leg strength and endurance Equipment: A chair with a straight back, without arm rests, placed against a wall to prevent it moving. Sit in the middle of the chair. Place each hand on the opposite shoulder crossed at the wrists. Place your feet flat on the floor. Keep your back straight and keep your arms against your chest. On "Go", rise to a full standing position and then sit back down again. Repeat this for 30 seconds. On "Go" begin timing. Do not continue if you feel the patient may fall during the test. Count the number of times the patient comes to a full standing position in 30 seconds and record it in the box below. If the patient is over halfway to a standing position when 30 seconds have elapsed, count it as a stand. If the patient must use his or her arms to stand then stop the test and record "0" for the number below.The western Ontario and McMaster universities osteoarthritis (womac) is a widely used by health professionals to evaluate the condition of patient with osteoarthritis of knee . womac measures 5 items for pain score 0-20. 2 for stiffness score 0-8 and 17 for functional limitation score 0-68. Physical functioning question of daily activities such as siting standing walking lying on bed taking of socks getting in or out of bath. Numeric pain rating scale (NPRs) is used for measure of pain intensity. In NPRS 0-10 integers that best reflects the intensity of pain. 0 represent no pain.

Previous studies were more focused on hydrotherapeutic exercises, muscle stretching strengthening, aerobics. There is still a challenge to explore best type of exercise therapy for improving sensorimotor function, alleviating symptoms and showing the disease process in different sub groups of patients with degenerative knee disease

Being tested
Neuro-muscular exercise training Group, quadriceps training program
Keywords
isolated quadriceps training, Neuro-muscular exercise training, knee Osteoarthritis
Medical subject headings
Osteoarthritis, Knee

What participants receive

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

  • Neuro-muscular exercise training GroupOther

    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

  • quadriceps training programOther

    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

Study groups in NCT03798002
Study groupRoleWhat they receive
Neuro-muscular exercise training GroupExperimentalNeuro-muscular exercise training will be administer to Knee OA patients.
Receives: Other: Neuro-muscular exercise training Group
quadriceps training programActive comparatorquadriceps stretching and strengthening exercises will be administer to Knee OA patients.
Receives: Other: quadriceps training program

What is being measured

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

  1. WOMAC Scale

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

    Measured: From baseline to 8th week

Secondary outcomes (1)
  1. Numeric pain rating scale(NPRS)

    Numeric pain rating scale is used to measure pain. Its score is from 0-10, with 0 means no pain and10 means worst pain.

    Measured: From baseline to 8th week

Timeline

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

  1. First posted9 Jan 2019
  2. Study start15 Jan 2019
  3. Primary completion30 Apr 2019
  4. Study completion30 Apr 2019

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03798002
Sponsor's protocol ID
RiphahI Maryam Khan
Status last verified
Aug 2019
First submitted
5 Jan 2019
Last updated
8 Aug 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19560995
  • 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.

    PubMed 9230035
  • 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
  • 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.

    PubMed 23461090
  • 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.

    PubMed 27836677
  • 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.

    PubMed 24931956
  • 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.

    PubMed 23924144
  • 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.

    PubMed 22141334

Questions about this trial

What is this clinical trial studying?

A study testing Neuro-muscular exercise training Group and quadriceps training program in people with Knee Osteoarthritis, run by Riphah International University at 2 sites 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 4 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 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

WOMAC Scale (time frame: From baseline to 8th week). 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 NCT03798002, which also lists 8 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 8 Aug 2019.

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