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Knee OsteoarthritisNCT06274346

Effect of Retro Walking Versus Isometric Multi-angular Exercises on Pain and Functional Performance in Knee Osteoarthritis in Geriatric Population

A study testing Multiangular Isometric exercise in people with Knee Osteoarthritis, run by Delta University for Science and Technology at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 to 90 years
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Multiangular Isometric exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
1 Jun 2023to 30 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Delta University For Science and Technology

    Gamasa, Almansourah, 38733

Other trials in Egypt

About this study

Official title: Effect of Retro Walking Versus Isometric Multi-angular Exercises on Pain and Functional Performance in Knee Osteoarthritis in Geriatric Population: A Randomized Controlled Study

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).

Read more

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)

Read the detailed description

Introduction:

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).

Biomechanical studies indicated individual with O.A. knee walk more slowly, with less knee excursion, increased adduction moment and with more joint stiffness. These secondary compensatory gait adaptation in O.A. knee patients helps in reducing pain by decreasing ground reaction loading on knee (5). This prolonged usage of secondary gait compensation creates greater imbalances of muscle, progressively reduces muscle strength, endurance, flexibility and later ending to deformity (6).

Therapeutic exercises are often used to improve physiological impairments such as reduced joint motion, muscle weakness, impaired balance, disability, and proprioception(7).

Retro-walking is sometimes referred to as backward walking, has been thought to be used already for several decades in China, Japan and Europe to get a physical workout, improve sport performance, promote balance and also to stay mentally fit (8). Retro-walking is walking backwards (9).

Since there is propulsion in backward direction and reversal of leg movement in Retro-walking, different muscle activation patterns from those in forward walking are required (10). Backward walking increases stride rate, decreases stride length and increases support time. Muscular structure supporting ankle and knee reversed their role during retro-walking. Backward walking produces significantly lower patellar compressive force than forward walking and helps to reduce maximal vertical force and impulsive force on knee in comparison to forward walking because of Toe heel contact pattern. Retro-walking is associated with increased cadence, decreased stride length and different joint kinematics as compared to forward walking and hence may offer some benefits over forward walking alone (11, 12).

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).

Inclusion criteria: 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.

Exclusion criteria: 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.

Patients were randomly assigned into two groups through computer software. We put sixty patients on the software program and the program assigned them randomly. The first group was treated by isometric multiangular 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. 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.

Procedures The patients were assessed twice; the first time was before the sessions. The second was at the end of the sessions. The visual analogue scale and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) were examined by a physical therapist who was trained for all assessments for 10 days before this study and was blinded for the study objectives.

Assessment 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).

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.

Intervention procedures:

Multiangular Isometric exercise group:

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.

The patients were then positioned into the isokinetic test and exercise system as described previously. The angle of the knee joint is 0˚ when it is straight. Likewise, the isometric exercise programme was performed for affected knee 3 sessions a week for 4 weeks (12 sessions) on the isokinetic device. This system allowed us to perform isometric exercises at different angles. In this way, each knee of the patient was subject to 3 repetitions with maximum effort for 5 sec of isometric contraction to the knee flexor and extensor muscles at 0, 30, 45, and 60_ joint angles, with angular velocity 0˚/SEC and rest periods of 5 sec between each contraction, and rest periods of 30 sec at the change of each angle. (18)

Retrograde walking group:

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. (19)

Pulsed short wave diathermy:

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. (20)

Being tested
Multiangular Isometric exercise
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multiangular Isometric exerciseOther

    Also called Retrograde walking

    already were described in arm descriptions

Study groups in NCT06274346
Study groupRoleWhat they receive
Multiangular Isometric exercise group:Active comparatorEach 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.
Receives: Other: Multiangular Isometric exercise
Retrograde walking group:ExperimentalEach 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.
Receives: Other: Multiangular Isometric exercise
Pulsed short wave diathermy:OtherPatient 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.
Receives: Other: Multiangular Isometric exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: pre the intervention and immediately after the intervention

  2. 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.

    Measured: pre the intervention and immediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2024
  2. Study start1 Jun 2023
  3. Primary completion10 Nov 2023
  4. Study completion30 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06274346
Sponsor's protocol ID
ahmedU
Status last verified
Jan 2024
First submitted
30 Jan 2024
Last updated
23 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Multiangular Isometric exercise in people with Knee Osteoarthritis, run by Delta University for Science and Technology at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain intensity (time frame: pre the intervention and immediately after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.

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