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

Primary Purpose

Sports Physical Therapy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Experimental Group
Control Group
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sports Physical Therapy

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Gymnastic physiotherapy and nutrition in bahria town Rawalpindi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Balance training + conventional exercises

Only conventional

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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).
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.

Secondary Outcome Measures

Full Information

First Posted
August 5, 2021
Last Updated
October 19, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04993911
Brief Title
Effects of Strength and Balance Training to Reduce the Fall Risk in Knee Osteoarthritis Patients
Official Title
Effects of Strength and Balance Training to Reduce the Fall Risk in Knee Osteoarthritis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 10, 2021 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sports Physical Therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Balance training + conventional exercises
Arm Type
Experimental
Arm Description
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
Arm Title
Only conventional
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
Experimental Group
Intervention Description
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
Intervention Name(s)
Control Group
Intervention Description
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
Primary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Description
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.
Time Frame
6-8 Weeks
Title
Numeric rate pain scale
Description
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).
Time Frame
6-8 Weeks
Title
Berg balance scale (BBS)
Description
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.
Time Frame
6-8 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suhail Karim, PP-DPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gymnastic physiotherapy and nutrition in bahria town Rawalpindi
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
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Effects of Strength and Balance Training to Reduce the Fall Risk in Knee Osteoarthritis Patients

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