AzTrials
AzTrials

Sports Physical TherapyNCT04993911

Effects of Strength and Balance Training to Reduce the Fall Risk in Knee Osteoarthritis Patients

A study testing Experimental Group in people with Sports Physical Therapy, run by Riphah International University at 1 site in Pakistan.

Completed

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

Official record
Search all trials

Trial summary

This study will address the scarcity of research and the variations in recommendations regarding the effects of strength and balance training to reduce the fall risk in knee osteoarthritis patients. Read more about this study

Who is it for?
Ages 55 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Sports Physical Therapy
What is being tested?
Experimental Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 sitePakistan
Study dates
10 Mar 2021to 30 Sep 2021
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 55 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age from 55 and 80 year
  • Both male and female patients.
  • Participants will need to have had knee pain for at least 6 months and experience current average pain of at least 3 (on an 11-point Numerical Pain Rating Scale (NRS)
  • Patients having no other physical and mental illness.
  • Osteoarthritis of knee (Stage-II) by kallgren and lawrence scale

Who cannot join

  • Patients with lab results abnormal (malignancy)
  • Nonmusculoskeletal conditions
  • Patient's undergone surgery of knee.
  • Other than osteoarthritis

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Gymnastic physiotherapy and nutrition in bahria town Rawalpindi

    Rawalpindi, Punjab Province, 44000

Other trials in Pakistan

About this study

This study will address the scarcity of research and the variations in recommendations regarding the effects of strength and balance training to reduce the fall risk in knee osteoarthritis patients.

Read the detailed description

This Study will be conducted in Alkhidmat Raazi Hospital. Written informed consent for inclusion in the study was taken. Patients of experimental group will receive balance training with conventional along with TENS, heating pad for one hour 3 times weekly. Assessment will be performed pre and post of intervention. Intervention will be given 3 days a week for 8 weeks.

Being tested
Experimental Group, Control Group

What participants receive

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

  • Experimental GroupOther

    Assessment will be performed pre and post of intervention. Intervention will be given 3 days a week for 8 weeks. Each session will include a 5-min warm-up on a fitness bike or treadmill before commencement of the program and a 5-min cool period. Participants of this group will receive balance training with conventional treatment. Participants will perform between 2 sets of 5 and 7 repetitions of each exercise.

    Single leg balance

    • Walking forward
    • Walking backward
    • Side stepping
    • Walk heel to toe
    • Static exercises with eyes close or open

    CONVENTIONAL EXERCISE PROGRAM :

    • TENS for 15 minutes
    • Hot pack for 15 minutes
    • Participants will perform between 2 sets of 7 and 10 repetitions of each exercise:
    • Quadriceps/hamstring isometric exercises.
    • ROM and active stretching of the hamstring and quadriceps muscle.
    • Active ankle pump.
    • Squats,step-up, sit to stand, calf raises
    • Straigh leg raising exercise in crook lying position
  • Control GroupOther

    Participants of this group will receive only conventional therapy which will include; before beginning the program, each session will feature a 5-minute warm-up on a fitness bike or treadmill, followed by a 5-minute cool-down. Participants of this group will receive only conventional therapy which will include.

    • CONVENTIONAL EXERCISE PROGRAM :
    • TENS for 15 minutes
    • Hot pack for 15 minutes
    • Participants will perform between 2 sets of 7 and 10 repetitions of each exercise:
    • Quadriceps/hamstring isometric exercises.
    • ROM and active stretching of the hamstring and quadriceps muscle.
    • Active ankle pump.
    • Squats,step-up, sit to stand, calf raises
    • Straigh leg raising exercise in crook lying position
Study groups in NCT04993911
Study groupRoleWhat they receive
Balance training + conventional exercisesExperimentalAssessment will be performed pre and post of intervention. Intervention will be given 3 days a week for 8 weeks. Each session will include a 5-min warm-up on a fitness bike or treadmill before commencement of the program and a 5-min cool period. Participants of this group will receive balance training with conventional treatment. Participants will perform between 2 sets of 5 and 7 repetitions of each exercise. Single leg balance Walking forward Walking backward Side stepping Walk heel to toe Static exercises with eyes close or open CONVENTIONAL EXERCISE PROGRAM : TENS for 15 minutes Hot pack for 15 minutes Participants will perform between 2 sets of 7 and 10 repetitions of each exercise: Quadriceps/hamstring isometric exercises. ROM and active stretching of the hamstring and quadriceps muscle. Active ankle pump. Squats,step-up, sit to stand, calf raises Straigh leg raising exercise in crook lying position
Receives: Other: Experimental Group
Only conventionalActive comparatorCONVENTIONAL EXERCISE PROGRAM : TENS for 15 minutes Hot pack for 15 minutes Participants will perform between 2 sets of 7 and 10 repetitions of each exercise: Quadriceps/hamstring isometric exercises. ROM and active stretching of the hamstring and quadriceps muscle. Active ankle pump. Squats,step-up, sit to stand, calf raises Straigh leg raising exercise in crook lying position
Receives: Other: Control Group

What is being measured

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

  1. Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    It is widely used in the evaluation of Knee Osteoarthritis. It is a questionnaire consisting of 24 items divided into 3 subscales. Pain (5 items), Stiffness (2 items) and Physical Function (17 items). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).

    The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

    Measured: 6-8 Weeks

  2. Numeric rate pain scale

    This is the scale to measure pain level of participants. is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).

    Measured: 6-8 Weeks

  3. Berg balance scale (BBS)

    To measure the functional performance of muscle, balance system. It grade the individual as having high, low and moderate risk of fall. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.

    Measured: 6-8 Weeks

Timeline

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

  1. First posted6 Aug 2021
  2. Study start10 Mar 2021
  3. Primary completion30 Sep 2021
  4. Study completion30 Sep 2021

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04993911
Sponsor's protocol ID
REC/00849 Mahrukh Hanif
Status last verified
Oct 2021
First submitted
5 Aug 2021
Last updated
27 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kim JK, Kim TH, Park SW, Kim HY, Kim Sh, Lee Sy, Lee SM. Protective effects of human placenta extract on cartilage degradation in experimental osteoarthritis. Biol Pharm Bull. 2010;33(6):1004-10. doi: 10.1248/bpb.33.1004.

    PubMed 20522967
  • 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
  • Srikanth VK, Fryer JL, Zhai G, Winzenberg TM, Hosmer D, Jones G. A meta-analysis of sex differences prevalence, incidence and severity of osteoarthritis. Osteoarthritis Cartilage. 2005 Sep;13(9):769-81. doi: 10.1016/j.joca.2005.04.014.

    PubMed 15978850
  • Maly MR. Abnormal and cumulative loading in knee osteoarthritis. Curr Opin Rheumatol. 2008 Sep;20(5):547-52. doi: 10.1097/BOR.0b013e328307f58c.

    PubMed 18698176
  • Kaufman KR, Hughes C, Morrey BF, Morrey M, An KN. Gait characteristics of patients with knee osteoarthritis. J Biomech. 2001 Jul;34(7):907-15. doi: 10.1016/s0021-9290(01)00036-7.

    PubMed 11410174
  • Bennell KL, Hunt MA, Wrigley TV, Hunter DJ, Hinman RS. The effects of hip muscle strengthening on knee load, pain, and function in people with knee osteoarthritis: a protocol for a randomised, single-blind controlled trial. BMC Musculoskelet Disord. 2007 Dec 7;8:121. doi: 10.1186/1471-2474-8-121.

    PubMed 18067658
  • Levinger P, Nagano H, Downie C, Hayes A, Sanders KM, Cicuttini F, Begg R. Biomechanical balance response during induced falls under dual task conditions in people with knee osteoarthritis. Gait Posture. 2016 Jul;48:106-112. doi: 10.1016/j.gaitpost.2016.04.031. Epub 2016 May 6.

    PubMed 27239773
  • Knoop J, Steultjens MP, van der Leeden M, van der Esch M, Thorstensson CA, Roorda LD, Lems WF, Dekker J. Proprioception in knee osteoarthritis: a narrative review. Osteoarthritis Cartilage. 2011 Apr;19(4):381-8. doi: 10.1016/j.joca.2011.01.003. Epub 2011 Jan 18.

    PubMed 21251988
  • Alnahdi AH, Zeni JA, Snyder-Mackler L. Muscle impairments in patients with knee osteoarthritis. Sports Health. 2012 Jul;4(4):284-92. doi: 10.1177/1941738112445726.

    PubMed 23016099
  • Smidt N, de Vet HC, Bouter LM, Dekker J, Arendzen JH, de Bie RA, Bierma-Zeinstra SM, Helders PJ, Keus SH, Kwakkel G, Lenssen T, Oostendorp RA, Ostelo RW, Reijman M, Terwee CB, Theunissen C, Thomas S, van Baar ME, van 't Hul A, van Peppen RP, Verhagen A, van der Windt DA; Exercise Therapy Group. Effectiveness of exercise therapy: a best-evidence summary of systematic reviews. Aust J Physiother. 2005;51(2):71-85. doi: 10.1016/s0004-9514(05)70036-2.

    PubMed 15924510
  • Sherrington C, Tiedemann A, Fairhall N, Close JC, Lord SR. Exercise to prevent falls in older adults: an updated meta-analysis and best practice recommendations. N S W Public Health Bull. 2011 Jun;22(3-4):78-83. doi: 10.1071/NB10056.

    PubMed 21632004
  • Diracoglu D, Aydin R, Baskent A, Celik A. Effects of kinesthesia and balance exercises in knee osteoarthritis. J Clin Rheumatol. 2005 Dec;11(6):303-10. doi: 10.1097/01.rhu.0000191213.37853.3d.

    PubMed 16371799
  • Sharma L, Cahue S, Song J, Hayes K, Pai YC, Dunlop D. Physical functioning over three years in knee osteoarthritis: role of psychosocial, local mechanical, and neuromuscular factors. Arthritis Rheum. 2003 Dec;48(12):3359-70. doi: 10.1002/art.11420.

    PubMed 14673987
  • 14. Aguiar GC, Rocha SG, Rezende GA, Nascimento MR, Scalzo PL. Effects of resistance training in individuals with knee osteoarthritis. Fisioterapia em Movimento. 2016 Sep;29(3):589-96

  • Silva A, Serrao PR, Driusso P, Mattiello SM. The effects of therapeutic exercise on the balance of women with knee osteoarthritis: a systematic review. Rev Bras Fisioter. 2012 Jan-Feb;16(1):1-9. English, Portuguese.

    PubMed 22441221

Questions about this trial

What is this clinical trial studying?

A study testing Experimental Group in people with Sports Physical Therapy, 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 5 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 27 Oct 2021. 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?

Western Ontario and McMaster Universities Arthritis Index (WOMAC) (time frame: 6-8 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 NCT04993911, which also lists 21 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 27 Oct 2021.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in