NCT06274346

Brief Summary

Osteoarthritis is a leading musculoskeletal cause of disability in elderly persons all over the world and a major cause of physical limitations and reduced quality of life (1). Its onset is around 40 years of age and it is estimated that over 80% of people over 55 have evidence of radiographic changes in the knee due to osteoarthritis. It has been estimated that the incidence has increased by the increase in life expectancy and it has been identified as a frequent cause for health services demand in patients over 65(2). The common clinical manifestations of knee OA include pain, stiffness, joint enlargement, crepitus, muscle weakness, deformity, impaired proprioception, reduced joint motion, and disability(3). Patients with knee Osteoarthritis seems to develop their own gait pattern and try to unload the affected structures during gait. More over patients with less severe knee osteoarthritis develop a gait pattern that differs from patients with severe osteoarthritis and control group of patients (4). Isometric exercises are types of strength training in which the joint angle and muscle length do not change during contraction, and therefore this approach can be advantageous in the early stages of knee rehabilitation in cases where the range of motion is restricted due to pain (13). No physical work is performed during isometric exercise. Intensity and duration combination reflects the energy consumption of an isometric contraction (14). In addition, muscle strength increases in isometric exercise are specific to the angle applied. It was also concluded that isometric exercise performed at different angles should be especially considered as an alternative strength training since it induces the most noticeable and fastest increase in muscle moment (15). A study was conducted to investigate the effects of isometric quadriceps exercise on muscle strength, pain, and function in knee osteoarthritis, it was concluded that isometric quadriceps exercise program showed beneficial effects on quadriceps muscle strength, pain, and functional disability in patients with osteoarthritis of the knee (16). Another study was conducted to assess the effectiveness of Isometric exercise and counseling on level of pain among patients with Knee osteoarthritis, the authors concluded that Isometric exercise and counseling program has significantly reduced pain, stiffness and improved physical function and the authors recommended that Isometric exercise and counselling should be adopted as a routine care in the hospitals treating patients with knee osteoarthritis (17) Thus, we hypothesized that a less intensive walking program such as retro walking program could provide an additional benefit more than those experienced by forward walking program in the previous studies. Therefore, the primary aim of the present study was to compare the effect of retro walking versus isometric multiangular exercises group on knee pain and function in geriatric people. Materials and Methods This randomized controlled experimental trial was carried out at the outpatient clinic of faculty of physical therapy, Delta University for science and technology from June 2023 to November 2023. The aims of the study and the study protocol were explained for each patient before participation in the study. All patients signed an approved informed consent form for participation in this study. Before starting the treatment program, a complete history and physical examination will be taken for all patients. Subjects: Sixty male and female geriatric patients had chronic knee osteoarthritis were chosen the outpatient clinic of faculty of physical therapy, Delta University for science and technology. In each case, the diagnosis of knee OA was based on the criteria specified by the American College of Rheumatology. We recorded the height, weight, and medical history, and lower extremity dominance, level of education, occupation and duration of complaints of each patient. All were evaluated at the beginning of the treatment (week 0), at the endpoint of the treatment (week 4)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable knee-osteoarthritis

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

Study Start

First participant enrolled

June 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2023

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2024

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
Last Updated

February 23, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

January 30, 2024

Last Update Submit

February 15, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Pain intensity

    It was examined by using a 10 cm long visual analogue scale (VAS) during both rest and activity (0 = no pain, 10 = very severe pain).

    pre the intervention and immediately after the intervention

  • Functional assessment:

    It was assessed with the Western Ontario and McMaster Universities Arthritis Index (WOMAC), which consists of 24 questions, specifically 5 for pain, 2 for joint stiffness and 17 related to functional status, each being scored from 1 to 5 On this metric, a high score suggests bad health, while relatively healthy subjects will have a low score. The assessments were grouped into four classifications, specifically WOMAC A for pain, WOMAC B for joint stiffness, WOMAC C for function status, and WOMAC-Total for the total score.

    pre the intervention and immediately after the intervention

Study Arms (3)

Multiangular Isometric exercise group:

ACTIVE COMPARATOR

Each patient was allowed to warm up for 10 minutes on the bicycle ergometer before each isometric exercise session. For this part of the study we position the patient on isokinetic device with the hip joint flexed at 90˚ the back supported with a backrest and the pelvis stabilized with a strap. The distal of the thigh was rested on a lifted support in the front of the seat and was wrapped with a strap. The center of rotation of the dynamometer was placed opposite the center of the femur lateral epicondyle. The lever arm of the dynamometer was set so that the load cell pad was comfortable against the lower part of the leg close to the lateral malleolus.

Other: Multiangular Isometric exercise

Retrograde walking group:

EXPERIMENTAL

Each patient was allowed to warm up for 10 minutes on the bicycle ergometer before each retrograde walking session. The patients were instructed to walk backwards for 10 min on a flat surface for a distance of 30 m at a comfortable speed supervised by the physiotherapist. Patients were required to walk backwards without looking behind. Safety measures were taken to ensure patients' well-being during retro walking. The physiotherapist stood beside the patients, gave them moral support, and guided them through the walking path till the patients are confident to walk on their own. The patient is also encouraged to increase their speed throughout the 4 weeks of rehabilitation.

Other: Multiangular Isometric exercise

Pulsed short wave diathermy:

OTHER

Patient is in supine lying, contra planer (transverse) method was used. The electrodes were placed over opposite aspects of the part i.e. knee. Timing: was applied for 20 minutes, 3 days/ week for duration of 4 weeks. After pulsed SWD, both groups were given static quadriceps exercise, dynamic quadriceps exercise, straight leg raise, prone knee bending, side lying hip abduction, prone hip extension for 10 repetitions with 5 seconds hold followed by 2 seconds rest for each exercise for a period of 3 days per week for duration of 4 weeks.

Other: Multiangular Isometric exercise

Interventions

already were described in arm descriptions

Also known as: Retrograde walking
Multiangular Isometric exercise group:Pulsed short wave diathermy:Retrograde walking group:

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female geriatric participants clinically diagnosed with osteoarthritis of knee by Orthopaedician; - Age more than 60 years
  • Participants having grade 2 and grade 3 as per Kellgren and Lawrence scale
  • The participants fulfilling clinical criteria listed by the American College of Rheumatology: knee pain and any three out of six: age \> 50 years, morning stiffness lasting \< 30 minutes, crepitus on active motion, bony tenderness, bony enlargement, no warmth on touch
  • Participants having knee pain for more than 6 weeks; Willingness to participate in the study.

You may not qualify if:

  • Participants with inflammatory joint disease of lower extremity, neurological disorder (motor and sensory loss), cardiac or metabolic condition
  • Participants involved in any form of physical exercise for lower extremity for at least 3 months
  • Participants taking pharmacological interventions
  • Participants taking an intra- articular injection for knee since last 6 months
  • Participants with history of recent surgery to hip, knee, ankle joint involving ligament, meniscus;
  • Participants with balance problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Delta University For Science and Technology

Gamasa, Almansourah, 38733, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Sixty male and female geriatric patients had chronic knee osteoarthritis were chosen the outpatient clinic of faculty of physical therapy, Delta University for science and technology. education, occupation and duration of complaints of each patient. All were evaluated at the beginning of the treatment (week 0), at the endpoint of the treatment (week 4).
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients were randomly assigned into two groups through computer software. We put sixty patients on the software program and the program assigned them randomly. s exercise, straight leg raise, prone knee bending, side lying hip abduction, prone hip extension with 5 seconds hold and a rest interval of 2 seconds for 10 repetitions for each exercise for a period of 4 weeks, 3 days per week was given. Second group was treated by retrowalking exercises in addition to physical therapy interventions including short wave diathermy and strengthening exercise such as static quadriceps exercise, dynamic quadriceps exercise, straight leg raise, prone knee bending, side lying hip abduction, prone hip extension with 5 seconds hold and a rest interval of 2 seconds for 10 repetitions for each exercise for a period of 4 weeks, 3 days per week was given., which were given 3 times/week for 4 consecutive weeks.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2024

First Posted

February 23, 2024

Study Start

June 1, 2023

Primary Completion

November 10, 2023

Study Completion

November 30, 2023

Last Updated

February 23, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations