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

October 19, 2021 updated by: Riphah International University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 44000
        • Gymnastic physiotherapy and nutrition in bahria town Rawalpindi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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
Active Comparator: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time Frame: 6-8 Weeks

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
Numeric rate pain scale
Time Frame: 6-8 Weeks
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
Berg balance scale (BBS)
Time Frame: 6-8 Weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Suhail Karim, PP-DPT, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2021

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

August 5, 2021

First Submitted That Met QC Criteria

August 5, 2021

First Posted (Actual)

August 6, 2021

Study Record Updates

Last Update Posted (Actual)

October 27, 2021

Last Update Submitted That Met QC Criteria

October 19, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/00849 Mahrukh Hanif

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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