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

NCT04993911 | Completed

• 1 other identifier: REC/00849 Mahrukh Hanif
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Sports Physical Therapy

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Balance training + conventional exercises

EXPERIMENTAL

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

Only conventional

ACTIVE COMPARATOR

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

Interventions

Experimental Group 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

Balance training + conventional exercises

Control Group 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

Only conventional

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with lab results abnormal (malignancy)
• Nonmusculoskeletal conditions
• Patient's undergone surgery of knee.
• Other than osteoarthritis

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Gymnastic physiotherapy and nutrition in bahria town Rawalpindi

Rawalpindi, Punjab Province, 44000, Pakistan

Location

Related Publications (21)

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  BACKGROUND

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  BACKGROUND

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

  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.

  PMID: 28821271 BACKGROUND

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  PMID: 2213777 BACKGROUND

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Suhail Karim, PP-DPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 6, 2021
• Study Start: March 10, 2021
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: October 27, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)