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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04993911
Other study ID # REC/00849 Mahrukh Hanif
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 10, 2021
Est. completion date September 30, 2021

Study information

Verified date October 2021
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date September 30, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years to 80 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Patients with lab results abnormal (malignancy) - Nonmusculoskeletal conditions - Patient's undergone surgery of knee. - Other than osteoarthritis

Study Design


Intervention

Other:
Experimental Group
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 Group
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

Locations

Country Name City State
Pakistan Gymnastic physiotherapy and nutrition in bahria town Rawalpindi Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (21)

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

16. Chhabr HK, Sathya P. Effect of conventional exercises with balance training &only conventional exercises in patients with osteoarthritis of knee. Int J Innov Res Sci Eng. 2015;4(7):5048-6.

17. Efficacy of Balance Training in Combination With Physical Therapy in Rehabilitation of Knee Osteoarthritis: A Randomized Clinical Trial

Alnahdi AH, Zeni JA, Snyder-Mackler L. Muscle impairments in patients with knee osteoarthritis. Sports Health. 2012 Jul;4(4):284-92. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Ferraz MB, Quaresma MR, Aquino LR, Atra E, Tugwell P, Goldsmith CH. Reliability of pain scales in the assessment of literate and illiterate patients with rheumatoid arthritis. J Rheumatol. 1990 Aug;17(8):1022-4. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Levinger P, Dunn J, Bifera N, Butson M, Elias G, Hill KD. High-speed resistance training and balance training for people with knee osteoarthritis to reduce falls risk: study protocol for a pilot randomized controlled trial. Trials. 2017 Aug 18;18(1):384. doi: 10.1186/s13063-017-2129-7. — View Citation

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. — View Citation

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

McConnell S, Kolopack P, Davis AM. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): a review of its utility and measurement properties. Arthritis Rheum. 2001 Oct;45(5):453-61. — View Citation

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. — View Citation

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. Review. — View Citation

Silva A, Serrão 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. Review. English, Portuguese. — View Citation

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. Review. — View Citation

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. — View Citation

Svensson M, Lind V, Löfgren Harringe M. Measurement of knee joint range of motion with a digital goniometer: A reliability study. Physiother Res Int. 2019 Apr;24(2):e1765. doi: 10.1002/pri.1765. Epub 2018 Dec 27. — View Citation

* Note: There are 21 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
6-8 Weeks
Primary 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). 6-8 Weeks
Primary 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. 6-8 Weeks
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