Osteoarthritis, KneeNCT05977374
Effects of Low Impact Elliptical Training on Knee Osteoarthritis Outcomes.
A study testing experimental and conventional group in people with Osteoarthritis, Knee, run by Riphah International University at 1 site in Pakistan.
Trial summary
This research study is determined to see the effects of low-impact elliptical training on knee osteoarthritis outcomes. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- experimental and conventional group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 12 Dec 2022to 27 Jun 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 40- to 65-year-old.
- Diagnosed cases of Grade 1 and 2 Knee OA.
- Healthy and overweight patients will be included. (18.5- 29.5)
Who cannot join
- Acute musculoskeletal injury.
- Low back pain and Sciatica.
- Hip and ankle pathology.
- Acute infection, fever.
- The patient taking supplements and medications.
- Any knee deformity.
Trial locations and contacts
1 site in 1 country.
About this study
This research study is determined to see the effects of low-impact elliptical training on knee osteoarthritis outcomes.
Read the detailed description
This study is designed to reduce the load of knee osteoarthritis patients in society so that the individual lives a healthy life without getting caught in any form of disability. Knee osteoarthritis is a progressive and degenerative disease of a joint that includes focal cartilage loss, bony hypertrophy, synovial capsule thickening, and changes in structures of periarticular ligaments and peripheral muscles.
There are several techniques used to overcome the individual's pain, for instance, the mobilization of the joint, prolotherapy, and the use of different electrical modalities. meanwhile, an elliptical workout provides a positive result in reducing the progression of overall knee joint and cartilage defects. elliptical training is included in low-impact activities which are proven joint-friendly activities for the better improvement of the knee joint.
This activity works on a similar principle of cyclic compressive loading as occurs in the manual mobilization of the knee joint. This activity brings out the fluid from the synovial membrane on compression and upon decompression, the cartilage reabsorbs the oxygen and nutrients, which crosses the synovial barrier into the synovial fluid through a double diffusion system in the joint. The fluid then reaches the extra-cellular matrix that moves to the multiple layers of chondrocytes for the growth of the cartilage in OA.
- Conditions
- Osteoarthritis, Knee
- Being tested
- experimental and conventional group
- Keywords
- Knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental and conventional groupOther
Also called Conventional group
Static stretchings of the lower limb, Ultrasound 1 MHz 1.5W/cm2 7 mins, knee isometrics, open chain activities, knee mobilizations grade 1 and 2, and home care plan.
| Study group | Role | What they receive |
|---|---|---|
| elliptical training group. | Experimental | In this group, Ultrasound 1MHz, 1.5W/cm2 7 mins, knee isometrics, and open chain activities. static stretching of the lower limbs will be given 10 reps each and held for 10 secs. 5 mins of warm-up activity on elliptical training will be given prior to the treatment group. then 3 mins of training with a set pace of 120 strides/min will start, then after 7 weeks, the timings will be increased to 5 mins. The base check-up will be conducted during 7 weeks and at the end of 12 weeks. Receives: Other: experimental and conventional group |
| Conventional treatment group | Other | Static stretching of the lower limbs as mentioned above, Ultrasound 1MHz 1.5W/cm2 7min, knee isometrics, open chain activities, anterior-posterior Maitland knee mobilizations grade 1 and 2, and home care plan. Receives: Other: experimental and conventional group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee joint pain.
Pain is measured through KOOS questionnaire, which is the part of the KOOS and it has 9 items to identify pain scoring. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
Measured: Baseline, 6th week and 12th week.
Knee joint X-rays.
From the X-rays we will measure the medial and lateral knee joint space width through Radiant software.
Measured: Baseline, 6th week and 12th week.
Knee joint stiffness and symptoms.
This is the part of KOOS questinnaire, it involves 5 items of symptoms and 2 items of stiffnss to rule out knee joint symptoms and stiffness. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
Measured: Baseline, 6th week and 12th week.
Activities of daily livings impact on knee joint
This is also the part of KOOS questionnaire, it includes 17 items to find out the scoring. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
Measured: Baseline, 6th week and 12th week.
Sports activity impact on knee joint
We can find the sports scoring through KOOS questionnaire, it embroils 5 items. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
Measured: Baseline, 6th week and 12th week.
Quality of life impact on knee joint
This one is also the part of KOOS questionnaire. it contain 4 items for scoring. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
Measured: Baseline, 6th week and 12th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start12 Dec 2022
- Primary completion30 May 2023
- Study completion27 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Collaborators
- Health Education Research Foundation (HERF)
- Responsible party
- Principal investigator, Waqar Ahmed Awan, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977374
- Sponsor's protocol ID
- 01238
- Status last verified
- Jul 2023
- First submitted
- 11 Jul 2023
- Last updated
- 4 Aug 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 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low Impact Elliptical Training on Knee Osteoarthritis Outcomes.
- ClinicalTrials.gov ID
- NCT05977374
- Acronym / sponsor ID
- 01238
- Conditions
- Osteoarthritis, Knee
- Keywords
- Knee osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Collaborators
- Health Education Research Foundation (HERF)
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 27 Jun 2023 (actual)
- First posted
- 4 Aug 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.
This research study is determined to see the effects of low-impact elliptical training on knee osteoarthritis outcomes.
Detailed description
This study is designed to reduce the load of knee osteoarthritis patients in society so that the individual lives a healthy life without getting caught in any form of disability. Knee osteoarthritis is a progressive and degenerative disease of a joint that includes focal cartilage loss, bony hypertrophy, synovial capsule thickening, and changes in structures of periarticular ligaments and peripheral muscles.
There are several techniques used to overcome the individual's pain, for instance, the mobilization of the joint, prolotherapy, and the use of different electrical modalities. meanwhile, an elliptical workout provides a positive result in reducing the progression of overall knee joint and cartilage defects. elliptical training is included in low-impact activities which are proven joint-friendly activities for the better improvement of the knee joint.
This activity works on a similar principle of cyclic compressive loading as occurs in the manual mobilization of the knee joint. This activity brings out the fluid from the synovial membrane on compression and upon decompression, the cartilage reabsorbs the oxygen and nutrients, which crosses the synovial barrier into the synovial fluid through a double diffusion system in the joint. The fluid then reaches the extra-cellular matrix that moves to the multiple layers of chondrocytes for the growth of the cartilage in OA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| elliptical training group. | Experimental | Other: experimental and conventional groupIn this group, Ultrasound 1MHz, 1.5W/cm2 7 mins, knee isometrics, and open chain activities. static stretching of the lower limbs will be given 10 reps each and held for 10 secs. 5 mins of warm-up activity on elliptical training will be given prior to the treatment group. then 3 mins of training with a set pace of 120 strides/min will start, then after 7 weeks, the timings will be increased to 5 mins. The base check-up will be conducted during 7 weeks and at the end of 12 weeks. |
| Conventional treatment group | Other | Other: experimental and conventional groupStatic stretching of the lower limbs as mentioned above, Ultrasound 1MHz 1.5W/cm2 7min, knee isometrics, open chain activities, anterior-posterior Maitland knee mobilizations grade 1 and 2, and home care plan. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 40- to 65-year-old.
- Diagnosed cases of Grade 1 and 2 Knee OA.
- Healthy and overweight patients will be included. (18.5- 29.5)
Key exclusion criteria (6 listed)
- Acute musculoskeletal injury.
- Low back pain and Sciatica.
- Hip and ankle pathology.
- Acute infection, fever.
- The patient taking supplements and medications.
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 |
|---|---|---|
| experimental and conventional groupAlso: Conventional groupStatic stretchings of the lower limb, Ultrasound 1 MHz 1.5W/cm2 7 mins, knee isometrics, open chain activities, knee mobilizations grade 1 and 2, and home care plan. | Other | Conventional treatment group, elliptical training group. |
Primary outcome
Knee joint pain.
Time frame: Baseline, 6th week and 12th week.
Pain is measured through KOOS questionnaire, which is the part of the KOOS and it has 9 items to identify pain scoring. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
Knee joint X-rays.
Time frame: Baseline, 6th week and 12th week.
From the X-rays we will measure the medial and lateral knee joint space width through Radiant software.
Knee joint stiffness and symptoms.
Time frame: Baseline, 6th week and 12th week.
This is the part of KOOS questinnaire, it involves 5 items of symptoms and 2 items of stiffnss to rule out knee joint symptoms and stiffness. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
Activities of daily livings impact on knee joint
Time frame: Baseline, 6th week and 12th week.
This is also the part of KOOS questionnaire, it includes 17 items to find out the scoring. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
Sports activity impact on knee joint
Time frame: Baseline, 6th week and 12th week.
We can find the sports scoring through KOOS questionnaire, it embroils 5 items. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
Quality of life impact on knee joint
Time frame: Baseline, 6th week and 12th week.
This one is also the part of KOOS questionnaire. it contain 4 items for scoring. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
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 4 Aug 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing experimental and conventional group in people with Osteoarthritis, Knee, run by Riphah International University at 1 site in Pakistan.
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 3 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 4 Aug 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 Pakistan. 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?
Knee joint pain. (time frame: Baseline, 6th week and 12th week.). The study lists 6 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 4 Aug 2023.