NCT06190977

Brief Summary

The aim of this research is to assess the effects of the Otago Exercise Program on Rehabilitation outcomes of balance strength and functional outcomes of post Total Knee Replacement patients. A randomized controlled trial that will include a total of 44 participants divided into two groups control and experimental. The experimental group will receive the Otago Exercise Program for four weeks, three times per week for forty to forty-five minutes. The control group will receive general TKR protocol for four weeks, three times per week for 30 minutes. Data collected will be analyzed through SPSS 25.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

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

December 19, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2025

Completed
Last Updated

July 8, 2025

Status Verified

July 1, 2025

Enrollment Period

12 months

First QC Date

December 19, 2023

Last Update Submit

July 2, 2025

Conditions

Keywords

Otago Exercise ProgrambalancestrengthosteoarthritisADLs

Outcome Measures

Primary Outcomes (1)

  • Berg balance scale

    Consists of 14 tasks and total score of 56.score of 0-20 indicates severe fall risk, 20-45 includes moderate risk of fall and 45-60 illustrates thr functional balances state.

    4th week

Secondary Outcomes (2)

  • timed up and go (TUG) test

    4th week

  • short physical performance battery

    4th week

Study Arms (2)

Otago Exercise Program

EXPERIMENTAL

Warm-up activities for 5 min head movement, neck movement, back stretching, trunk movement, and ankle movement. strength and balance training for 30 mins Strengthening training include sitting knee extension, standing hip abduction, standing knee flexion, tiptoe and heel tiptoe Balance training include standing on one foot, walking in the shape of the number eight, walking sideways, walking backward, standing to sit position training, knee bending, toe to heel standing, heel walking, toe to heel walking, toe to heel walking, toe to heel walking, toe to heel walking backward, and climbing stairs Walking training for 10 min

Other: Otago Exercise Program

General TKR ptotocol

OTHER

Ankle pumps Straight leg raises Heel slides Seated knee extensions Standing knee flexion Calf raises Quadriceps contraction Stationary bike

Other: General TKR pprotocol

Interventions

Exercises will include Intensity: 10 repetitions of each set for the first two weeks and 15 repetitions of each set for the last two weeks, Frequency 3 sessions per week for 4 weeks. Time= 40-45 minutes

Otago Exercise Program

Exercises will include Intensity: 10 repetitions of each set, Frequency 5 sessions per week for 4 weeks. Time= 30 minutes

General TKR ptotocol

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both genders
  • Age 45 or above
  • weeks since replacement surgery
  • Berge balance scale 21-40
  • Patients should have received medical clearance from their surgeon or health care provider to engage in an exercise program

You may not qualify if:

  • History of recent musculoskeletal injury of lower limb
  • Patients have undergone revision TKR
  • Patient with moderate cognitive impairment
  • Patients with unstable medical conditions or active infection
  • Patient with specific contraindications to exercise as determined by their healthcare provider such as blood clots or severe osteoporosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIRM

Islamabad, Punjab Province, Pakistan

Location

Related Publications (16)

  • Nakano N, Shoman H, Olavarria F, Matsumoto T, Kuroda R, Khanduja V. Why are patients dissatisfied following a total knee replacement? A systematic review. Int Orthop. 2020 Oct;44(10):1971-2007. doi: 10.1007/s00264-020-04607-9. Epub 2020 Jul 8.

    PMID: 32642827BACKGROUND
  • Bukhari SI, Allana AR, Najjad KR, Noor SS, Chinoy A. Epidemiology of hip & knee replacement across Pakistan: Multicenter cross-sectional study. Pak J Med Sci. 2023 Nov-Dec;39(6):1557-1561. doi: 10.12669/pjms.39.6.7006.

    PMID: 37936780BACKGROUND
  • Tolpadi AA, Lee JJ, Pedoia V, Majumdar S. Deep Learning Predicts Total Knee Replacement from Magnetic Resonance Images. Sci Rep. 2020 Apr 14;10(1):6371. doi: 10.1038/s41598-020-63395-9.

    PMID: 32286452BACKGROUND
  • Jester R, Rodney A. The relationship between obesity and primary Total Knee Replacement: A scoping review of the literature. Int J Orthop Trauma Nurs. 2021 Jul;42:100850. doi: 10.1016/j.ijotn.2021.100850. Epub 2021 Feb 16.

    PMID: 34044216BACKGROUND
  • Bravi M, Longo UG, Laurito A, Greco A, Marino M, Maselli M, Sterzi S, Santacaterina F. Supervised versus unsupervised rehabilitation following total knee arthroplasty: A systematic review and meta-analysis. Knee. 2023 Jan;40:71-89. doi: 10.1016/j.knee.2022.11.013. Epub 2022 Nov 18.

    PMID: 36410253BACKGROUND
  • Hadamus A, Bialoszewski D, Blazkiewicz M, Kowalska AJ, Urbaniak E, Wydra KT, Wiaderna K, Boratynski R, Kobza A, Marczynski W. Assessment of the Effectiveness of Rehabilitation after Total Knee Replacement Surgery Using Sample Entropy and Classical Measures of Body Balance. Entropy (Basel). 2021 Jan 29;23(2):164. doi: 10.3390/e23020164.

    PMID: 33573057BACKGROUND
  • de Lima F, Melo G, Fernandes DA, Santos GM, Rosa Neto F. Effects of total knee arthroplasty for primary knee osteoarthritis on postural balance: A systematic review. Gait Posture. 2021 Sep;89:139-160. doi: 10.1016/j.gaitpost.2021.04.042. Epub 2021 Apr 30.

    PMID: 34284334BACKGROUND
  • Dominguez-Navarro F, Silvestre-Munoz A, Igual-Camacho C, Diaz-Diaz B, Torrella JV, Rodrigo J, Paya-Rubio A, Roig-Casasus S, Blasco JM. A randomized controlled trial assessing the effects of preoperative strengthening plus balance training on balance and functional outcome up to 1 year following total knee replacement. Knee Surg Sports Traumatol Arthrosc. 2021 Mar;29(3):838-848. doi: 10.1007/s00167-020-06029-x. Epub 2020 Apr 27.

    PMID: 32342139BACKGROUND
  • Labanca L, Iovine R, Bragonzoni L, Barone G, Farella GM, Benedetti MG. Instrumented platforms for balance and proprioceptive assessment in patients with total knee replacement: A systematic review and meta-analysis. Gait Posture. 2020 Sep;81:230-240. doi: 10.1016/j.gaitpost.2020.07.080. Epub 2020 Aug 8.

    PMID: 32810699BACKGROUND
  • Sun JN, Shan YZ, Wu LX, Li N, Xu FH, Kong XR, Zhang B. Preoperative high-intensity strength training combined with balance training can improve early outcomes after total knee arthroplasty. J Orthop Surg Res. 2023 Sep 15;18(1):692. doi: 10.1186/s13018-023-04197-3.

    PMID: 37715204BACKGROUND
  • Chiu HL, Yeh TT, Lo YT, Liang PJ, Lee SC. The effects of the Otago Exercise Programme on actual and perceived balance in older adults: A meta-analysis. PLoS One. 2021 Aug 6;16(8):e0255780. doi: 10.1371/journal.pone.0255780. eCollection 2021.

    PMID: 34358276BACKGROUND
  • Peng Y, Yi J, Zhang Y, Sha L, Jin S, Liu Y. The effectiveness of a group-based Otago exercise program on physical function, frailty and health status in older nursing home residents: A systematic review and meta-analysis. Geriatr Nurs. 2023 Jan-Feb;49:30-43. doi: 10.1016/j.gerinurse.2022.10.014. Epub 2022 Nov 19.

    PMID: 36413811BACKGROUND
  • Viveiro LAP, Gomes GCV, Bacha JMR, Carvas Junior N, Kallas ME, Reis M, Jacob Filho W, Pompeu JE. Reliability, Validity, and Ability to Identity Fall Status of the Berg Balance Scale, Balance Evaluation Systems Test (BESTest), Mini-BESTest, and Brief-BESTest in Older Adults Who Live in Nursing Homes. J Geriatr Phys Ther. 2019 Oct/Dec;42(4):E45-E54. doi: 10.1519/JPT.0000000000000215.

    PMID: 30407272BACKGROUND
  • Demircioglu A, Kezban Sahin U, Acaroz S. Discriminative Ability of the Four Balance Measures for Previous Fall Experience in Turkish Community-Dwelling Older Adults. J Aging Phys Act. 2022 Mar 18;30(6):980-986. doi: 10.1123/japa.2021-0415. Print 2022 Dec 1.

    PMID: 35303710BACKGROUND
  • Lauretani F, Ticinesi A, Gionti L, Prati B, Nouvenne A, Tana C, Meschi T, Maggio M. Short-Physical Performance Battery (SPPB) score is associated with falls in older outpatients. Aging Clin Exp Res. 2019 Oct;31(10):1435-1442. doi: 10.1007/s40520-018-1082-y. Epub 2018 Dec 4.

    PMID: 30515724BACKGROUND
  • Phu S, Kirk B, Bani Hassan E, Vogrin S, Zanker J, Bernardo S, Duque G. The diagnostic value of the Short Physical Performance Battery for sarcopenia. BMC Geriatr. 2020 Jul 13;20(1):242. doi: 10.1186/s12877-020-01642-4.

    PMID: 32660438BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Sara Aabroo, Nmpt

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2023

First Posted

January 5, 2024

Study Start

January 1, 2024

Primary Completion

December 30, 2024

Study Completion

January 28, 2025

Last Updated

July 8, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations