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

NCT ID: NCT04993911

Last Updated: 2021-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-10

Study Completion Date

2021-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sports Physical Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Balance training + conventional exercises

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

Group Type EXPERIMENTAL

Experimental Group

Intervention Type OTHER

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

Only conventional

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

Group Type ACTIVE_COMPARATOR

Control Group

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Suhail Karim, PP-DPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Gymnastic physiotherapy and nutrition in bahria town Rawalpindi

Rawalpindi, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 20522967 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19751691 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15978850 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 18698176 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11410174 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18067658 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27239773 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21251988 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23016099 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15924510 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21632004 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16371799 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14673987 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 22441221 (View on PubMed)

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.

Reference Type BACKGROUND

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 28821271 (View on PubMed)

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. doi: 10.1002/1529-0131(200110)45:53.0.co;2-w. No abstract available.

Reference Type BACKGROUND
PMID: 11642645 (View on PubMed)

Svensson M, Lind V, Lofgren 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.

Reference Type BACKGROUND
PMID: 30589162 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2213777 (View on PubMed)

Other Identifiers

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REC/00849 Mahrukh Hanif

Identifier Type: -

Identifier Source: org_study_id