Knee OsteoarthritisNCT07402447
Effect of Combined Quadriceps and Calf Strengthening Program on Gait in Knee Osteoarthritis Patients
A study testing Group A (Combined Quadriceps and Calf Strengthening) and Group B( Conventional) in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this study is to determine the effects of a combined quadriceps and calf strengthening program on gait, strength, pain, disability, functional mobility, and sleep quality in patients with knee osteoarthritis. A randomized controlled trial will be conducted at Hayatabad Medical Complex, Peshawar. 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?
- Group A (Combined Quadriceps and Calf Strengthening) and Group B( Conventional)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Both Male and Female
- Participants aged 40-60years.
- Diagnosed with grade 2 and 3 of knee osteoarthritis according to Kellgren-Lawrence
- Quads manual muscle grading <4
- Ability to understand and comply with exercise instructions.
Who cannot join
- History of recent knee surgery or trauma in the past six months.
- Inflammatory joint diseases (e.g., rheumatoid arthritis, gout).
- Severe cardiovascular or neurological disorders.
- Uncontrolled hypertension or diabetes.
- Participation in other physiotherapy or pharmacological interventions for knee OA during the study period.
- Cognitive impairment or inability to follow commands
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Hayatabad Medical Complex
Peshawar, Khyber Pakhtunkhwa, 25000
Aisha Razzaq, PHD*, 03015030784, aisha.razzaq@riphah.edu.pk
Sarah Rehman, MSPT
About this study
Official title: Effect of Combined Quadriceps and Calf Strengthening Program on Gait, Functionality, and Sleep Quality in Knee Osteoarthritis Patients
The aim of this study is to determine the effects of a combined quadriceps and calf strengthening program on gait, strength, pain, disability, functional mobility, and sleep quality in patients with knee osteoarthritis. A randomized controlled trial will be conducted at Hayatabad Medical Complex, Peshawar. A total of 52 participants aged 40-60 years with grade 2-3 knee osteoarthritis will be recruited using non-probability convenience sampling and randomly allocated into experimental and control groups. Outcome measures include Kinovea software for gait analysis, hand-held dynamometer for strength, Numeric Rating Scale for pain, WOMAC for disability, Timed Up and Go test for function, and Pittsburgh Sleep Quality Index for sleep quality. Data will be analyzed using SPSS version 27 employing repeated measures ANOVA and mixed-way ANOVA.
Read the detailed description
Knee osteoarthritis (KOA) is a chronic, progressive degenerative condition commonly affecting older adults and is a major cause of disability. It is characterized by degeneration of articular cartilage, subchondral bone changes, and synovial inflammation. KOA results in pain, stiffness, impaired balance, reduced physical function, and diminished quality of life, leading to significant psychological and socioeconomic burden. Knee osteoarthritis (KOA) develops due to several factors including mechanical stress, obesity, joint injury, aging-related cartilage wear and tear, genetic predisposition, and low-grade inflammation that damages the cartilage.
Physical therapy is a key component of KOA management and focuses on pain reduction, restoration of joint mobility, and improvement in functional ability and quality of life through exercises such as quadriceps strengthening, gait and balance training, and aerobic or aquatic exercises. Quadriceps strengthening helps stabilize the knee joint, reduce abnormal loading, and improve shock absorption, thereby decreasing joint stress during daily activities.
In addition to quadriceps weakness, patients with KOA commonly exhibit reduced calf muscle strength compared to healthy individuals. The calf muscles, particularly the gastrocnemius, play an important role in knee stabilization, load absorption, and functional movements such as walking. Altered gastrocnemius activation during weight-bearing activities can negatively affect knee biomechanics and contribute to disease progression. Muscle strengthening exercises have been shown to improve muscle strength, balance, and reduce joint inflammation in KOA patients.
Literature review: In a study carried out by Paul DeVita et al in 2018 weaker quadriceps increased the risk and progression of KOA, while strengthening the quadriceps improves pain, physical function, and quality of life by providing better knee stability and reducing joint stress.
A 2020 study by Ali M. Alshami et al. reported that compared to healthy adults, calf muscle weakness and atrophy is common in patients with KOA, with muscle strength notably decreased despite flexibility and girth not being significantly affected to be.
Zhanliang Tan et al in 2025 stated that HKE targeting gastronomies muscle effectively and safely alleviated knee pain and restored function.
A systemic review by Disha D hedge et al in 2025 states that Quadriceps strengthening as a part of lower extremity strengthening is effective in reducing pain in KOA. Emine Kiyak (2018) reported that about 81% of KOA patients significant difficulties in maintaining sleep. Patients with KOA suffered from night pain, which significantly disrupted sleep and contributed to poorer overall sleep quality, ultimately diminishing quality of life.
- Conditions
- Knee Osteoarthritis
- Being tested
- Group A (Combined Quadriceps and Calf Strengthening), Group B( Conventional)
- Keywords
- Calf Strengthening, Gait, Sleep quality, Quadriceps Strengthening
- Medical subject headings
- Osteoarthritis, Knee, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A (Combined Quadriceps and Calf Strengthening)Other
During weeks 1-2, Group A will receive a heating pad for 10 minutes followed by Grade II joint mobilization. This will be followed by strengthening exercises including quadriceps strengthening in the form of straight leg raises, quadriceps sets, and leg extension exercises with 1 kg weight. Calf strengthening exercises will also be performed, including standing heel raises, seated calf raises, and standing single heel raises with support. All exercises will be initially performed with 10 repetitions and 1 set.
During weeks 3-4, the exercise protocol will progress by increasing the repetitions to 12, sets to 2, and external resistance to 1.5 kg.
During weeks 5-6, further progression will be made by increasing the repetitions to 15, sets to 3, and external resistance to 2 kg.
Group B( Conventional)Other
During weeks 1-2, Group B will receive a heating pad for 10 minutes followed by Grade II joint mobilization. This will be followed by quadriceps strengthening in the form of straight leg raises, quadriceps sets, and leg extension exercises with 1 kg weight. All exercises will be initially performed with 10 repetitions and 1 set.
During weeks 3-4, the exercise protocol will progress by increasing the repetitions to 12, sets to 2, and external resistance to 1.5 kg.
During weeks 5-6, further progression will be made by increasing the repetitions to 15, sets to 3, and external resistance to 2 kg.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Combined Quadriceps and Calf Strengthening) | Experimental | The experimental group will receive physiotherapy treatment consisting of the application of a heating pad for 10 minutes, followed by Grade II joint mobilization, quadriceps strengthening exercises, and calf strengthening exercises Receives: Other: Group A (Combined Quadriceps and Calf Strengthening) |
| Group B (Conventional) | Active comparator | The control group will receive conventional physiotherapy treatment, which included the application of a heating pad for 10 minutes, followed by Grade II joint mobilization, and quadriceps strengthening exercises. Receives: Other: Group B( Conventional) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temporo-spatial Gait
Gait parameters will be measured by Kinovea Software.A video of the gait will be recorded and then evaluated with kinovea.
Measured: from baseline to 6 weeks
Quadriceps Strength
the Hand Held Dynamometer will be used to asses the strength of quadriceps
Measured: from baseline to 6 weeks
Calf Strength
the Hand Held Dynamometer will be used to asses the strength of Calf
Measured: from baseline to 6 weeks
Secondary outcomes (4)
Knee Pain
Pain will be assessed using Numeric Rating Scale(NRS). it is an 11-point scale comprising a number from 0 through 10; 0 indicates "no pain", and 10 indicates the "worst imaginable pain".
Measured: from baseline to 6 weeks
knee Disability
it will be assessed using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), . It consists of 24 items in subscale measuring pain, stiffness and physical function.
Measured: from baseline to 6 weeks
knee Function
Time up and Go test will be used, TUG is an easy and quick test to assess the patient's functional mobility
Measured: from baseline to 6 weeks
Sleep Quality
The Pittsburgh Sleep Quality Index (PSQI) will be used to assess sleep quality. the PSQI measures seven domains of sleep quality: subjective sleep quality, sleep latency (time to fall asleep initially), sleep duration, sleep efficiency (percent of time in bed spent asleep), sleep disturbances, use of sleep medications, and daytime dysfunction
Measured: from baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start1 Feb 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aisha Razzaq, PHD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402447
- Sponsor's protocol ID
- RiphahIU - Sarah Rehman
- Status last verified
- Sep 2026
- First submitted
- 4 Feb 2026
- Last updated
- 9 Sep 2026
- 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combined Quadriceps and Calf Strengthening Program on Gait, Functionality, and Sleep Quality in Knee Osteoarthritis Patients
- ClinicalTrials.gov ID
- NCT07402447
- Acronym / sponsor ID
- RiphahIU - Sarah Rehman
- Conditions
- Knee Osteoarthritis
- Keywords
- Calf Strengthening, Gait, Sleep quality, Quadriceps Strengthening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 11 Feb 2026 (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 this study is to determine the effects of a combined quadriceps and calf strengthening program on gait, strength, pain, disability, functional mobility, and sleep quality in patients with knee osteoarthritis. A randomized controlled trial will be conducted at Hayatabad Medical Complex, Peshawar. A total of 52 participants aged 40-60 years with grade 2-3 knee osteoarthritis will be recruited using non-probability convenience sampling and randomly allocated into experimental and control groups. Outcome measures include Kinovea software for gait analysis, hand-held dynamometer for strength, Numeric Rating Scale for pain, WOMAC for disability, Timed Up and Go test for function, and Pittsburgh Sleep Quality Index for sleep quality. Data will be analyzed using SPSS version 27 employing repeated measures ANOVA and mixed-way ANOVA.
Detailed description
Knee osteoarthritis (KOA) is a chronic, progressive degenerative condition commonly affecting older adults and is a major cause of disability. It is characterized by degeneration of articular cartilage, subchondral bone changes, and synovial inflammation. KOA results in pain, stiffness, impaired balance, reduced physical function, and diminished quality of life, leading to significant psychological and socioeconomic burden. Knee osteoarthritis (KOA) develops due to several factors including mechanical stress, obesity, joint injury, aging-related cartilage wear and tear, genetic predisposition, and low-grade inflammation that damages the cartilage.
Physical therapy is a key component of KOA management and focuses on pain reduction, restoration of joint mobility, and improvement in functional ability and quality of life through exercises such as quadriceps strengthening, gait and balance training, and aerobic or aquatic exercises. Quadriceps strengthening helps stabilize the knee joint, reduce abnormal loading, and improve shock absorption, thereby decreasing joint stress during daily activities.
In addition to quadriceps weakness, patients with KOA commonly exhibit reduced calf muscle strength compared to healthy individuals. The calf muscles, particularly the gastrocnemius, play an important role in knee stabilization, load absorption, and functional movements such as walking. Altered gastrocnemius activation during weight-bearing activities can negatively affect knee biomechanics and contribute to disease progression. Muscle strengthening exercises have been shown to improve muscle strength, balance, and reduce joint inflammation in KOA patients.
Literature review: In a study carried out by Paul DeVita et al in 2018 weaker quadriceps increased the risk and progression of KOA, while strengthening the quadriceps improves pain, physical function, and quality of life by providing better knee stability and reducing joint stress.
A 2020 study by Ali M. Alshami et al. reported that compared to healthy adults, calf muscle weakness and atrophy is common in patients with KOA, with muscle strength notably decreased despite flexibility and girth not being significantly affected to be.
Zhanliang Tan et al in 2025 stated that HKE targeting gastronomies muscle effectively and safely alleviated knee pain and restored function.
A systemic review by Disha D hedge et al in 2025 states that Quadriceps strengthening as a part of lower extremity strengthening is effective in reducing pain in KOA. Emine Kiyak (2018) reported that about 81% of KOA patients significant difficulties in maintaining sleep. Patients with KOA suffered from night pain, which significantly disrupted sleep and contributed to poorer overall sleep quality, ultimately diminishing quality of life.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Combined Quadriceps and Calf Strengthening) | Experimental | Other: Group A (Combined Quadriceps and Calf Strengthening)The experimental group will receive physiotherapy treatment consisting of the application of a heating pad for 10 minutes, followed by Grade II joint mobilization, quadriceps strengthening exercises, and calf strengthening exercises |
| Group B (Conventional) | Active comparator | Other: Group B( Conventional)The control group will receive conventional physiotherapy treatment, which included the application of a heating pad for 10 minutes, followed by Grade II joint mobilization, and quadriceps strengthening exercises. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Both Male and Female
- Participants aged 40-60years.
- Diagnosed with grade 2 and 3 of knee osteoarthritis according to Kellgren-Lawrence
- Quads manual muscle grading <4
- Ability to understand and comply with exercise instructions.
Key exclusion criteria (6 listed)
- History of recent knee surgery or trauma in the past six months.
- Inflammatory joint diseases (e.g., rheumatoid arthritis, gout).
- Severe cardiovascular or neurological disorders.
- Uncontrolled hypertension or diabetes.
- Participation in other physiotherapy or pharmacological interventions for knee OA during the study period.
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 |
|---|---|---|
| Group A (Combined Quadriceps and Calf Strengthening)During weeks 1-2, Group A will receive a heating pad for 10 minutes followed by Grade II joint mobilization. This will be followed by strengthening exercises including quadriceps strengthening in the form of straight leg raises, quadriceps sets, and leg extension exercises with 1 kg weight. Calf strengthening exercises will also be performed, including standing heel raises, seated calf raises, and standing single heel raises with support. All exercises will be initially performed with 10 repetitions and 1 set. During weeks 3-4, the exercise protocol will progress by increasing the repetitions to 12, sets to 2, and external resistance to 1.5 kg. During weeks 5-6, further progression will be made by increasing the repetitions to 15, sets to 3, and external resistance to 2 kg. | Other | Group A (Combined Quadriceps and Calf Strengthening) |
| Group B( Conventional)During weeks 1-2, Group B will receive a heating pad for 10 minutes followed by Grade II joint mobilization. This will be followed by quadriceps strengthening in the form of straight leg raises, quadriceps sets, and leg extension exercises with 1 kg weight. All exercises will be initially performed with 10 repetitions and 1 set. During weeks 3-4, the exercise protocol will progress by increasing the repetitions to 12, sets to 2, and external resistance to 1.5 kg. During weeks 5-6, further progression will be made by increasing the repetitions to 15, sets to 3, and external resistance to 2 kg. | Other | Group B (Conventional) |
Primary outcome
Temporo-spatial Gait
Time frame: from baseline to 6 weeks
Gait parameters will be measured by Kinovea Software.A video of the gait will be recorded and then evaluated with kinovea.
Quadriceps Strength
Time frame: from baseline to 6 weeks
the Hand Held Dynamometer will be used to asses the strength of quadriceps
Calf Strength
Time frame: from baseline to 6 weeks
the Hand Held Dynamometer will be used to asses the strength of Calf
4 secondary outcomes
Knee Pain
Time frame: from baseline to 6 weeks
knee Disability
Time frame: from baseline to 6 weeks
knee Function
Time frame: from baseline to 6 weeks
Sleep Quality
Time frame: from baseline to 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- 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.
Aisha Razzaq, PHD principal investigator
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 Group A (Combined Quadriceps and Calf Strengthening) and Group B( Conventional) 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 5 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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aisha Razzaq, PHD (03015030784, aisha.razzaq@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temporo-spatial Gait (time frame: from baseline to 6 weeks). The study lists 3 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 9 Sep 2026.