Knee OsteoarthritisNCT05173649
Calisthenic and Neuromuscular Training in Patients With Knee OA.
A study testing Calisthenic Training and Neuromuscular Training in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of the study is to compare effects of calisthenics and neuromuscular training in patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Calisthenic Training and Neuromuscular Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 11 Nov 2021to 30 Jan 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with chronic OA (symptoms for more than 3 months).
- Subjects willing to participate and take treatment.
- Grade of 2 to 3 as per Kellegren and Lawrence radiographic classification.
Who cannot join
- Subjects having any systemic joint pathologies, inflammatory joint disease (e.g.
- Rheumatoid arthritis, gouty arthritis, psoriatic arthritis).
- Subjects who had any neurological deficit (paresthesia, sensory loss, radiculopathy, myelopathy any mental illness (Dementia, Alzheimer's, Parkinson disease etc.) that can affect orientation and concentration.
- Subjects on medication like antidepressants, corticosteroid, and anti-inflammatory medications.
- Peripheral vascular diseases.
- Any history of surgery related to lower extremity.
- Subjects having metal implants in the lower limb
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Calisthenics and Neuromuscular Training in Patients With Knee Osteoarthritis.
The aim of the study is to compare effects of calisthenics and neuromuscular training in patients with knee osteoarthritis.
Read the detailed description
OsteoArthristis (OA) is the most frequent form of arthritis and a leading cause of pain and disability worldwide. OA can affect any synovial joint, although the hip, knee, hand, foot and spine are the most commonly affected sites.
The knee is the most commonly affected joint and knee OA (KOA) represents the leading joint disorder in the world. At present, there is no preventive or curative drug treatment available for KOA.
Physical therapy plays a significant role in treating patients with knee OA. Rehabilitation enables the patient to cope with their daily task independently and mainly focus on self-help and patient-driven treatments rather than on passive therapies delivered by clinicians.
A systemic review was conducted on Comparative Effect of Calisthenics and Proprioceptive Exercises on Pain, Proprioception, Balance and Function in Chronic Osteoarthritis of Knee. According to this study Light intensity Calisthenics exercises are effective and can be recommended as an adjunct to conventional physiotherapy for the patients with Osteoarthritis knee.
Another research was conducted on Efficacy of Neuromuscular Training on Pain, Balance and Function in Patients with Grade I and II Knee Osteoarthritis. The results shows that although conventional exercise program is effective in reducing knee pain, and increasing lower extremity muscle strength and range of motion, adding neuromuscular training (KBA) along with conventional exercise program in rehabilitation leads to higher improvement on balance and function in patient with knee grade I and II osteoarthritis.
A positive effect has been observed in treating patients with both the interventions.
The past research records are evident that therapists have determined individual effects of calisthenics and neuromuscular training for rehabilitation of Knee OA. The evidence for implementation of two protocols for rehabilitation of Knee OA is sparse. So the aim of the study is to compare effects of calisthenics and neuromuscular training in patients with knee osteoarthritis.
- Conditions
- Knee Osteoarthritis
- Being tested
- Calisthenic Training, Neuromuscular Training
- Keywords
- Calisthenic training, Neuromuscular training, 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.
Calisthenic TrainingOther
Also called Group A
Calisthenic Training Performed thrice a week after baseline assessment Standard Physical therapy treatment along with following exercises.
- Abductor-Adductor leg raise
- Alternate toe touch
- Knee Bend
- Prone leg extension
- Forward Lunges
- Toe Raise/ Calf raise Progressive training include following exercises.
- Leg Lifts 2. Jack Twists 3. Side Lunges 4. Short bridge 5. Calf Raise with weight.
Neuromuscular TrainingOther
Also called Group B
Neuromuscular Training Performed thrice a week after baseline assessment Standard Physical therapy treatment along with following exercises.
- Up and down step exercise in posterior and lateral directions.
- Walking in anterior and posterior
- Directions with eyes opened and eyes closed.
- Walking in lateral direction with eyes opened and eyes closed.
- Standing on one extremity
- Inclination in anterior and lateral direction with eyes opened and closed. Progressive training includes following exercises.
- Up and down on Bosu exercise. 2. Plantar flexion on minitrampoline. 3. Standing on one extremity on Bosu. 4. Standing on one extremity on minitrampoline
| Study group | Role | What they receive |
|---|---|---|
| Calisthenic Training | Experimental | Calisthenic Training Group Receives: Other: Calisthenic Training; Other: Neuromuscular Training |
| Neuromuscular Training Group | Experimental | Neuromuscular Training Group Receives: Other: Calisthenic Training; Other: Neuromuscular Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index)
Changes are measured from baseline. This test is used to measure physical function. The maximum score is 96 Higher the score the worst is pain, stiffness and physical function.
Measured: 6 weeks
NPRS(Numeric pain rating scale)
Changes are measured from baseline. The test is used to measure pain. It score ranges from 0 to 10 with 0 indicating no pain and 10 is for pain as severe as possible
Measured: 6 weeks
Short Physical Performance Battery
Changes are measured from baseline. The test is used to measure balance ,lower extremity strength and functional capacity with maximum score of 12. Score less than 10 indicates disability.
Measured: 6 weeks
Mini BES-Test
Changes are measured from baseline. It is 36 items scales that evaluates Balance with total score of 28
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start11 Nov 2021
- Primary completion30 Jan 2022
- Study completion30 Jan 2022
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.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aruba Saeed, PhD*, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173649
- Sponsor's protocol ID
- REC/00956 Tayyeba Majid
- Status last verified
- Apr 2022
- First submitted
- 18 Nov 2021
- Last updated
- 18 Apr 2022
- 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 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Calisthenics and Neuromuscular Training in Patients With Knee Osteoarthritis.
- ClinicalTrials.gov ID
- NCT05173649
- Acronym / sponsor ID
- REC/00956 Tayyeba Majid
- Conditions
- Knee Osteoarthritis
- Keywords
- Calisthenic training, Neuromuscular training, Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 30 Dec 2021 (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.
The aim of the study is to compare effects of calisthenics and neuromuscular training in patients with knee osteoarthritis.
Detailed description
OsteoArthristis (OA) is the most frequent form of arthritis and a leading cause of pain and disability worldwide. OA can affect any synovial joint, although the hip, knee, hand, foot and spine are the most commonly affected sites.
The knee is the most commonly affected joint and knee OA (KOA) represents the leading joint disorder in the world. At present, there is no preventive or curative drug treatment available for KOA.
Physical therapy plays a significant role in treating patients with knee OA. Rehabilitation enables the patient to cope with their daily task independently and mainly focus on self-help and patient-driven treatments rather than on passive therapies delivered by clinicians.
A systemic review was conducted on Comparative Effect of Calisthenics and Proprioceptive Exercises on Pain, Proprioception, Balance and Function in Chronic Osteoarthritis of Knee. According to this study Light intensity Calisthenics exercises are effective and can be recommended as an adjunct to conventional physiotherapy for the patients with Osteoarthritis knee.
Another research was conducted on Efficacy of Neuromuscular Training on Pain, Balance and Function in Patients with Grade I and II Knee Osteoarthritis. The results shows that although conventional exercise program is effective in reducing knee pain, and increasing lower extremity muscle strength and range of motion, adding neuromuscular training (KBA) along with conventional exercise program in rehabilitation leads to higher improvement on balance and function in patient with knee grade I and II osteoarthritis.
A positive effect has been observed in treating patients with both the interventions.
The past research records are evident that therapists have determined individual effects of calisthenics and neuromuscular training for rehabilitation of Knee OA. The evidence for implementation of two protocols for rehabilitation of Knee OA is sparse. So the aim of the study is to compare effects of calisthenics and neuromuscular training in patients with knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calisthenic Training | Experimental | Other: Calisthenic Training, Other: Neuromuscular TrainingCalisthenic Training Group |
| Neuromuscular Training Group | Experimental | Other: Calisthenic Training, Other: Neuromuscular TrainingNeuromuscular Training Group |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with chronic OA (symptoms for more than 3 months).
- Subjects willing to participate and take treatment.
- Grade of 2 to 3 as per Kellegren and Lawrence radiographic classification.
Key exclusion criteria (7 listed)
- Subjects having any systemic joint pathologies, inflammatory joint disease (e.g.
- Rheumatoid arthritis, gouty arthritis, psoriatic arthritis).
- Subjects who had any neurological deficit (paresthesia, sensory loss, radiculopathy, myelopathy any mental illness (Dementia, Alzheimer's, Parkinson disease etc.) that can affect orientation and concentration.
- Subjects on medication like antidepressants, corticosteroid, and anti-inflammatory medications.
- Peripheral vascular diseases.
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 |
|---|---|---|
| Calisthenic TrainingAlso: Group ACalisthenic Training Performed thrice a week after baseline assessment Standard Physical therapy treatment along with following exercises. 1. Abductor-Adductor leg raise 2. Alternate toe touch 3. Knee Bend 4. Prone leg extension 5. Forward Lunges 6. Toe Raise/ Calf raise Progressive training include following exercises. 1. Leg Lifts 2. Jack Twists 3. Side Lunges 4. Short bridge 5. Calf Raise with weight. | Other | Calisthenic Training, Neuromuscular Training Group |
| Neuromuscular TrainingAlso: Group BNeuromuscular Training Performed thrice a week after baseline assessment Standard Physical therapy treatment along with following exercises. 1. Up and down step exercise in posterior and lateral directions. 2. Walking in anterior and posterior 3. Directions with eyes opened and eyes closed. 4. Walking in lateral direction with eyes opened and eyes closed. 5. Standing on one extremity 6. Inclination in anterior and lateral direction with eyes opened and closed. Progressive training includes following exercises. 1. Up and down on Bosu exercise. 2. Plantar flexion on minitrampoline. 3. Standing on one extremity on Bosu. 4. Standing on one extremity on minitrampoline | Other | Calisthenic Training, Neuromuscular Training Group |
Primary outcome
WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index)
Time frame: 6 weeks
Changes are measured from baseline. This test is used to measure physical function. The maximum score is 96 Higher the score the worst is pain, stiffness and physical function.
NPRS(Numeric pain rating scale)
Time frame: 6 weeks
Changes are measured from baseline. The test is used to measure pain. It score ranges from 0 to 10 with 0 indicating no pain and 10 is for pain as severe as possible
Short Physical Performance Battery
Time frame: 6 weeks
Changes are measured from baseline. The test is used to measure balance ,lower extremity strength and functional capacity with maximum score of 12. Score less than 10 indicates disability.
Mini BES-Test
Time frame: 6 weeks
Changes are measured from baseline. It is 36 items scales that evaluates Balance with total score of 28
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 18 Apr 2022.
- 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.
Aruba Saeed, PhD* study chair
Riphah International 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 Calisthenic Training and Neuromuscular Training in people with Knee Osteoarthritis, 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 7 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 18 Apr 2022. 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?
WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index) (time frame: 6 weeks). The study lists 4 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 18 Apr 2022.