Knee OsteoarthritisNCT05671146
An Evaluation of the Graded Weight-bearing Exercise in Patients With Knee Osteoarthritis.
A study testing anti-gravity treadmill, Weight-bearing exercises for knee flexors and extensors and Non weight-bearing exercises for knee flexors and extensors in people with Knee Osteoarthritis, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
Trial summary
Background: Knee osteoarthritis is the most common disorder impacting the synovial joint. The prevalence of osteoarthritis rises with age, and its consequences on health and socioeconomic are significant, which emphasize the need for clinical and cost-effective treatments for patients with knee OA. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- anti-gravity treadmill, Weight-bearing exercises for knee flexors and extensors and Non weight-bearing exercises for knee flexors and extensors
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 25 Dec 2022to 10 Jul 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients had chronic pain in either unilateral or bilateral knees ≥ 6 months.
- The x-ray showed grades II and III according to on Kallgren and Lawrence (K/L) grading system.
- Patients are willing to stop medications.
- Patients accepted to assign informed consent to participate in the current study and will attend the lab twice a week for six successive weeks.
Who cannot join
- They have any known significant medical conditions such as hypertension, asthma, cardiac disease, or systemic disease that adversely affect them during testing.
- Previous knee surgery/injection for the last six months.
- Previous knee fracture or malignancy.
- Unable to walk unaided.
- Unable to commit study requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of the Graded Weight-bearing Exercise on Pain, Function, Proprioception, and Muscle Strengths in Patients With Knee Osteoarthritis.
Background: Knee osteoarthritis is the most common disorder impacting the synovial joint. The prevalence of osteoarthritis rises with age, and its consequences on health and socioeconomic are significant, which emphasize the need for clinical and cost-effective treatments for patients with knee OA. Knee OA is a widespread joint arthritis disease combined with many clinical features such as pain, decreased joint proprioception and might lead to loss of function and disability.
Aim: To evaluate the effect of a 6-weeks supervised graded weight-bearing exercise program on pain, function, proprioception, muscle strength in patients with knee osteoarthritis.
Read more
Material and Method: Thirty-six patients with chronic knee osteoarthritis with age ranging 40-60 years will be recruited from the physical therapy department and randomized into three groups. Group I: will receive graded weight-bearing exercise using the anti-gravity treadmill combined with open kinetic chain exercises. Group II will receive closed kinetic chain exercises with open kinetic chain exercises while group III will receive open kinetic chain exercises only i.e: stretching and strengthening exercises. The outcome measures will be pain, function, proprioception, and muscle strength.
Statistical analysis: To detect changes in the dependent variables within and between groups, one-way repeated measures Multivariate analysis will be applied. If there is a significant change within groups or between tests, the post hoc Bonferroni test will be used to detect the significance between each group and/or each level of measurement. The level of significance is p<0.05 and confidence interval CI 95%.
Study Design: Single-blinded, randomised control trial.
Read the detailed description
Study design: This study is a single-blinded randomized controlled trial. after baseline assessment, the participants will be assigned randomly into three groups, the graded weight-bearing exercise group, the closed kinetic chain exercise group, and the control group. First, randomization will be performed by allocating a specific number for each participant. Then, Online GraphPad will be applied to randomize these numbers into three groups. The participants' allocation will be conducted by a person who is not in contact with the participants or involved in any testing. The allocation sequence will be saved on that person's computer. Following randomization, the participant will be notified by phone about which group they will be assigned to.
Study setting: The current study will be held at the laboratory at Umm Al-Qura University, Faculty of Applied Medical Sciences, Makkah, Saudi Arabia Recruitment and study population Patients will be recruited from the physical therapy outpatient clinic, Umm Al-Qura university medical centre, and other physical therapy outpatient clinic in Makkah.
Intervention group:
The intervention will be constructed based on recent clinical exercise guidelines for people with knee osteoarthritis. These guidelines mainly recommend weight-bearing exercises, progressive resistance training for lower limb major muscle groups, and aerobic exercise. The exercise regimen will be applied at two sessions per week for six weeks. The intervention is designed as the group I will perform progressive weight-bearing using an anti-gravity treadmill, the loading starts with patient tolerance - pain-free range and increases gradually, combined with open kinetic chain exercises. Group II will perform closed kinetic chain exercises with open kinetic chain exercises. Most of the exercises in these groups will be achieved in a weight-bearing position, with or without support, besides other exercises to improve knee flexors and extensors strength. An experienced physiotherapist will observe the intervention. Participants who have a higher risk of falling, restricted weight-bearing activities, or movement during training and activities will be given extra attention to avoid injuries. The physiotherapists will be trained to deliver the weight-bearing exercise program and ensure that participants have access to support devices. The session will last one hour and be repeated twice a week for six weeks. Participants' customizing, appropriate dosage, and progression of the exercises will be the responsibility of the physiotherapist supervising the exercise session. The exercise regimen will begin with a 10-minute warm-up that includes stretching, flexibility, and dynamic balance exercises. The warm-up will be followed by a graded weight-bearing exercise for group I and a closed kinetic chain exercise for group II with a short break for 30 seconds. Each session will end with 10 min cooling down and stretching. Participants are encouraged to report any significant side effects from the exercise, such as muscular soreness, joint tenderness, or increased pain level.
Control group:
Participants assigned to the control group will receive open kinetic chain exercises only, including stretching and strengthening exercises for knee flexors and extensors. They will be expected to maintain their current level of physical activity and go about their daily lives as usual.
Adherence:
The percentage of total intervention days completed will be used to determine adherence. 12 sessions = 100%.
Sample size estimation: A G-power grogram for windows is used to calculate the estimated sample size with an effect size of 0.25 and an alpha error probability of 0.90 to detect the changes in three groups receiving three independent interventions for four dependent variables. The measurement will be repeated twice across the study period. The statistical test used is the Multivariate Analysis of variance (MANOVA), and the total sample size will be 36. The number will be increased for possible dropout to 45 patients with 15 patients in each group. Statistical Analysis The study's findings will be presented in accordance with CONSORT.
Statistical analysis: will be carried out with the help of statistical software such as SPSS. Patients' demographic data will be presented as mean and standard deviation. Analysis of the patients' age (years), weight (Kg), height (cm), and body mass index (BMI) kg/m2 will be performed by one-way analysis of variance (ANOVA) to detect the similarity in subjects between the treatment groups. Three treatment groups that received three different interventions will be measured twice at pre-treatment and post-treatment. To detect changes in the dependent variables within and between groups, one-way repeated measures Multivariate analysis (MANOVA) will be applied. If there is a significant change within groups or between tests, the post hoc Bonferroni test will be used to detect the significance between each group and/or each level of measurement. The level of significance is p<0.05. The data will be analyzed with the intention to treat principles. Each paper from the project will be subjected to a statistical analysis publication plan.
- Conditions
- Knee Osteoarthritis
- Being tested
- anti-gravity treadmill, Weight-bearing exercises for knee flexors and extensors, Non weight-bearing exercises for knee flexors and extensors
- Keywords
- Graded weight-bearing exercise, Anti-gravity treadmill
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-gravity treadmillDevice
participants will perform exercises with partial weight-bearing by using an anti-gravity treadmill
Weight-bearing exercises for knee flexors and extensorsOther
Stretching and strengthening exercises will be performed in a weight-bearing position
Non weight-bearing exercises for knee flexors and extensorsOther
Stretching and strengthening exercises will be performed in a non-weight-bearing position
| Study group | Role | What they receive |
|---|---|---|
| Graded weight-bearing exercise | Experimental | participants will perform exercises using an anti-gravity treadmill Receives: Device: anti-gravity treadmill |
| Closed kinetic chain exercise | Active comparator | Exercises will be achieved in a weight-bearing position, with or without support, besides other exercises to improve knee flexors and extensors strength. Receives: Other: Weight-bearing exercises for knee flexors and extensors |
| open kinetic chain exercise | Sham comparator | Exercises including stretching and strengthening exercises for knee flexors and extensors Receives: Other: Non weight-bearing exercises for knee flexors and extensors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurment of pain intensity
The pain will be measured using a visual analogue scale (VAS). This scale is a 10-centimeter drawn line. Zero indicates no pain or discomfort, and 10 indicates the most severe pain. The patient will be asked to mark on the line corresponding to their pain level. For patients with chronic musculoskeletal pain, the VAS is a valid and reliable measure.
Measured: Change from Baseline Pain Intensity at 6 weeks post-intervention
Function
The function will be measured by WOMAC. The WOMAC index is a sensitive, validated, and reliable measure of knee osteoarthritis impacts such as functional conditions. The WOMAC scale has 17 items used to assess patients with osteoarthritis physical function. The patient's response runs from 1 to 5, with 1 indicating no response and 5 indicating a strong response. The total score will be calculated by adding the scores for each item.
Measured: Change from Baseline Functional level at 6 weeks post-intervention
Secondary outcomes (2)
Proprioception
The proprioception will be measured using the joint position sense method. The Biodex System isokinetic dynamometer is a reliable apparatus for measuring angular joint position.
Measured: Change from Baseline Knee Joint Proprioception at 6 weeks post-intervention
Muscle strength
The dynamometer is a proven and accurate way to assess quadriceps muscle strength. To control the effects of fatigue, the strength testing was done in the order of 120°/s, 180°/s, and finally 60°/s. On the testing side, participants are set leaning against a backrest tilted 15 degrees backward from vertical and will be strapped to the machine at the upper chest, pelvis, and distal femur. The participants will be instructed to extend their knee as far as possible, with the highest values from the three trials recorded as peak torque at each speed. The gravity of all data will be rectified.
Measured: Change from Baseline Quadriceps Muscles strength at 6 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start25 Dec 2022
- Primary completion28 Mar 2023
- Study completion10 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Collaborators
- Umm Al-Qura University
- Responsible party
- Principal investigator, Ammar Fadil, Imam Abdulrahman Bin Faisal University
- Investigators
- Ammar S Fadil, Ph.D, Principal investigator, Imam Abdulrahman Bin Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671146
- Sponsor's protocol ID
- IRB-PGS-2022-03-447
- Status last verified
- Oct 2023
- First submitted
- 7 Dec 2022
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Graded Weight-bearing Exercise on Pain, Function, Proprioception, and Muscle Strengths in Patients With Knee Osteoarthritis.
- ClinicalTrials.gov ID
- NCT05671146
- Acronym / sponsor ID
- IRB-PGS-2022-03-447
- Conditions
- Knee Osteoarthritis
- Keywords
- Graded weight-bearing exercise, Anti-gravity treadmill
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Collaborators
- Umm Al-Qura University
- Study start
- 25 Dec 2022 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Knee osteoarthritis is the most common disorder impacting the synovial joint. The prevalence of osteoarthritis rises with age, and its consequences on health and socioeconomic are significant, which emphasize the need for clinical and cost-effective treatments for patients with knee OA. Knee OA is a widespread joint arthritis disease combined with many clinical features such as pain, decreased joint proprioception and might lead to loss of function and disability.
Aim: To evaluate the effect of a 6-weeks supervised graded weight-bearing exercise program on pain, function, proprioception, muscle strength in patients with knee osteoarthritis.
Material and Method: Thirty-six patients with chronic knee osteoarthritis with age ranging 40-60 years will be recruited from the physical therapy department and randomized into three groups. Group I: will receive graded weight-bearing exercise using the anti-gravity treadmill combined with open kinetic chain exercises. Group II will receive closed kinetic chain exercises with open kinetic chain exercises while group III will receive open kinetic chain exercises only i.e: stretching and strengthening exercises. The outcome measures will be pain, function, proprioception, and muscle strength.
Statistical analysis: To detect changes in the dependent variables within and between groups, one-way repeated measures Multivariate analysis will be applied. If there is a significant change within groups or between tests, the post hoc Bonferroni test will be used to detect the significance between each group and/or each level of measurement. The level of significance is p<0.05 and confidence interval CI 95%.
Study Design: Single-blinded, randomised control trial.
Detailed description
Study design: This study is a single-blinded randomized controlled trial. after baseline assessment, the participants will be assigned randomly into three groups, the graded weight-bearing exercise group, the closed kinetic chain exercise group, and the control group. First, randomization will be performed by allocating a specific number for each participant. Then, Online GraphPad will be applied to randomize these numbers into three groups. The participants' allocation will be conducted by a person who is not in contact with the participants or involved in any testing. The allocation sequence will be saved on that person's computer. Following randomization, the participant will be notified by phone about which group they will be assigned to.
Study setting: The current study will be held at the laboratory at Umm Al-Qura University, Faculty of Applied Medical Sciences, Makkah, Saudi Arabia Recruitment and study population Patients will be recruited from the physical therapy outpatient clinic, Umm Al-Qura university medical centre, and other physical therapy outpatient clinic in Makkah.
Intervention group:
The intervention will be constructed based on recent clinical exercise guidelines for people with knee osteoarthritis. These guidelines mainly recommend weight-bearing exercises, progressive resistance training for lower limb major muscle groups, and aerobic exercise. The exercise regimen will be applied at two sessions per week for six weeks. The intervention is designed as the group I will perform progressive weight-bearing using an anti-gravity treadmill, the loading starts with patient tolerance - pain-free range and increases gradually, combined with open kinetic chain exercises. Group II will perform closed kinetic chain exercises with open kinetic chain exercises. Most of the exercises in these groups will be achieved in a weight-bearing position, with or without support, besides other exercises to improve knee flexors and extensors strength. An experienced physiotherapist will observe the intervention. Participants who have a higher risk of falling, restricted weight-bearing activities, or movement during training and activities will be given extra attention to avoid injuries. The physiotherapists will be trained to deliver the weight-bearing exercise program and ensure that participants have access to support devices. The session will last one hour and be repeated twice a week for six weeks. Participants' customizing, appropriate dosage, and progression of the exercises will be the responsibility of the physiotherapist supervising the exercise session. The exercise regimen will begin with a 10-minute warm-up that includes stretching, flexibility, and dynamic balance exercises. The warm-up will be followed by a graded weight-bearing exercise for group I and a closed kinetic chain exercise for group II with a short break for 30 seconds. Each session will end with 10 min cooling down and stretching. Participants are encouraged to report any significant side effects from the exercise, such as muscular soreness, joint tenderness, or increased pain level.
Control group:
Participants assigned to the control group will receive open kinetic chain exercises only, including stretching and strengthening exercises for knee flexors and extensors. They will be expected to maintain their current level of physical activity and go about their daily lives as usual.
Adherence:
The percentage of total intervention days completed will be used to determine adherence. 12 sessions = 100%.
Sample size estimation: A G-power grogram for windows is used to calculate the estimated sample size with an effect size of 0.25 and an alpha error probability of 0.90 to detect the changes in three groups receiving three independent interventions for four dependent variables. The measurement will be repeated twice across the study period. The statistical test used is the Multivariate Analysis of variance (MANOVA), and the total sample size will be 36. The number will be increased for possible dropout to 45 patients with 15 patients in each group. Statistical Analysis The study's findings will be presented in accordance with CONSORT.
Statistical analysis: will be carried out with the help of statistical software such as SPSS. Patients' demographic data will be presented as mean and standard deviation. Analysis of the patients' age (years), weight (Kg), height (cm), and body mass index (BMI) kg/m2 will be performed by one-way analysis of variance (ANOVA) to detect the similarity in subjects between the treatment groups. Three treatment groups that received three different interventions will be measured twice at pre-treatment and post-treatment. To detect changes in the dependent variables within and between groups, one-way repeated measures Multivariate analysis (MANOVA) will be applied. If there is a significant change within groups or between tests, the post hoc Bonferroni test will be used to detect the significance between each group and/or each level of measurement. The level of significance is p<0.05. The data will be analyzed with the intention to treat principles. Each paper from the project will be subjected to a statistical analysis publication plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Graded weight-bearing exercise | Experimental | Device: anti-gravity treadmillparticipants will perform exercises using an anti-gravity treadmill |
| Closed kinetic chain exercise | Active comparator | Other: Weight-bearing exercises for knee flexors and extensorsExercises will be achieved in a weight-bearing position, with or without support, besides other exercises to improve knee flexors and extensors strength. |
| open kinetic chain exercise | Sham comparator | Other: Non weight-bearing exercises for knee flexors and extensorsExercises including stretching and strengthening exercises for knee flexors and extensors |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients had chronic pain in either unilateral or bilateral knees ≥ 6 months.
- The x-ray showed grades II and III according to on Kallgren and Lawrence (K/L) grading system.
- Patients are willing to stop medications.
- Patients accepted to assign informed consent to participate in the current study and will attend the lab twice a week for six successive weeks.
Key exclusion criteria (5 listed)
- They have any known significant medical conditions such as hypertension, asthma, cardiac disease, or systemic disease that adversely affect them during testing.
- Previous knee surgery/injection for the last six months.
- Previous knee fracture or malignancy.
- Unable to walk unaided.
- Unable to commit study requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti-gravity treadmillparticipants will perform exercises with partial weight-bearing by using an anti-gravity treadmill | Device | Graded weight-bearing exercise |
| Weight-bearing exercises for knee flexors and extensorsStretching and strengthening exercises will be performed in a weight-bearing position | Other | Closed kinetic chain exercise |
| Non weight-bearing exercises for knee flexors and extensorsStretching and strengthening exercises will be performed in a non-weight-bearing position | Other | open kinetic chain exercise |
Primary outcome
Measurment of pain intensity
Time frame: Change from Baseline Pain Intensity at 6 weeks post-intervention
The pain will be measured using a visual analogue scale (VAS). This scale is a 10-centimeter drawn line. Zero indicates no pain or discomfort, and 10 indicates the most severe pain. The patient will be asked to mark on the line corresponding to their pain level. For patients with chronic musculoskeletal pain, the VAS is a valid and reliable measure.
Function
Time frame: Change from Baseline Functional level at 6 weeks post-intervention
The function will be measured by WOMAC. The WOMAC index is a sensitive, validated, and reliable measure of knee osteoarthritis impacts such as functional conditions. The WOMAC scale has 17 items used to assess patients with osteoarthritis physical function. The patient's response runs from 1 to 5, with 1 indicating no response and 5 indicating a strong response. The total score will be calculated by adding the scores for each item.
2 secondary outcomes
Proprioception
Time frame: Change from Baseline Knee Joint Proprioception at 6 weeks post-intervention
Muscle strength
Time frame: Change from Baseline Quadriceps Muscles strength at 6 weeks post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ammar S Fadil, Ph.D principal investigator
Imam Abdulrahman Bin Faisal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anti-gravity treadmill, Weight-bearing exercises for knee flexors and extensors and Non weight-bearing exercises for knee flexors and extensors in people with Knee Osteoarthritis, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
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 5 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 10 Oct 2023. 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 Saudi Arabia. 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. Some participants in this study may receive a placebo. 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?
Measurment of pain intensity (time frame: Change from Baseline Pain Intensity at 6 weeks post-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 10 Oct 2023.