PostmenopausalNCT06658327
Comparative Effects Of Dynamic And Static Stretching In Postmenopausal Females With Knee Osteoarthritis
A study testing Dynamic stretching and Static stretching in people with Postmenopausal and Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
Trial summary
As the aging population continues to grow, there is a pressing need to explore effective interventions to alleviate the symptoms of osteoarthritis, particularly in postmenopausal women who may experience unique challenges. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women only
- Conditions the study is for
- Postmenopausal, Knee Osteoarthritis
- What is being tested?
- Dynamic stretching and Static stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Apr 2024to 30 Nov 2024
- 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 50 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50 to 65
- Diagnosed patients of OA with grade 3
- Multiparous (5 children)
- Fertile females
- Pain greater than 6 on NPRS
Who cannot join
- BMI > 30
- Early menarche ≤10 or 11 years.
- Cancer i.e breast cancer ,Ovrian cancer
- Any bone deformity before menopause i.e limb length discrepancy, angulation
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
Mafaza-Tul-Hayat Hospital
Lahore, Punjab Province
Adeela Arif, Mphil, 03320845723, adeela.arif@riphah.edu.pk
About this study
Official title: Comparative Effects Of Dynamic And Static Stretching On Pain, Lower Extremity Function And Knee Range Of Motion In Postmenopausal Females With Knee Osteoarthritis
As the aging population continues to grow, there is a pressing need to explore effective interventions to alleviate the symptoms of osteoarthritis, particularly in postmenopausal women who may experience unique challenges. Osteoarthritis (OA) is progressive joint disease characterized by joint inflammation and a reparative bone response and is one of the top five most disabling conditions that affects more than one-third of persons >65 years of age, commonly affecting hands, feet, spine, hips, and knees. Among the various therapeutic modalities, stretching exercises, both dynamic and static, have gained attention for their potential to enhance joint flexibility, reduce pain, and improve functional outcomes.
Read the detailed description
The study will be a randomized clinical trial and will be conducted in Jinnah Hospital, Mafaza-Tul-Hayat Hospital Lahore and Mayo Hospital Lahore. This study will be completed in time duration of 7 months after the approval of synopsis. Non-probability convenience sampling technique will be used and 58 participants will be recruited in study after randomization. The subjects will be divided into two groups. Group A will receive dynamic stretching of hamstrings and quadriceps with static stretching and Group B will receive dynamic stretching without static stretching after warm up as baseline treatment. The tools that will be used are Osteoarthritis outcome scale Goniometer Lower extremity function scale, Strength, MMT, NPRS, after data collection data will be analyzed by using SPSS version 21
- Conditions
- Postmenopausal, Knee Osteoarthritis
- Being tested
- Dynamic stretching, Static stretching
- Keywords
- Pain, Postmenopausal, knee Osteoarthritis, Dynamic Stretching, Static Stretching
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic stretchingOther
Group A will receive 2*10 repetitions of dynamic stretching of hamstrings and calf muscles in standing position after application of hot pack (standard size which had been stored in a hydro collator tank of 74.5-80°C for 30 minutes) with 6-8 layers of towel was applied on lower extremity for 10 minutes The subjects will be asked to stand upright with their feet parallel and facing forward with hands holding onto something. Each treatment session will last for 30 minutes. The protocol will be repeated every day for 5 days from the first day of treatment.
Static stretchingOther
Group B will receive 2*10 repetitions of static stretching of hamstrings and quads in standing position after application of hot pack (standard size which had been stored in a hydro collator tank of 74.5-80°C for 30 minutes) with 6-8 layers of towel was applied on lower extremity for 10 minutes. The subjects will be asked to stand upright with their feet parallel and facing forward with hands holding onto something. Each treatment session will last for 30 minutes. The protocol will be repeated every day for 5 days from the first day of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Dynamic stretching Receives: Other: Dynamic stretching |
| Group B | Experimental | Static Stretching Receives: Other: Static stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
GONIOMETER
Goniometer is a device used to measure joint ranges. Goniometric measurement of ROM is an important part of clinical examination in osteoarthritis knee and can give information about available knee joint motion, guide about pattern of management, and prognosis.
Measured: 6 Weeks
LOWER EXTREMITY FUNCTION SCALE
The LEFS scores demonstrated excellent test-retest reliability (intraclass correlation coefficients ranging between 0.85 and 0.99) and demonstrated the expected relationships with measures assessing similar constructs.
Measured: 6 Weeks
STRENGTH MMT
MMT is the most commonly used method for documenting impairments in muscle strength. Manual muscle testing is used in rehabilitation and recovery to evaluate contractile units, including muscles and tendons, and their ability to generate forces.
Measured: 6 Weeks
Numerical Pain Rating Scale
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain.
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 posted26 Oct 2024
- Study start24 Apr 2024
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PostmenopausalStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tanzeela Majeed, MS, Principal investigator, Ripah International university, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658327
- Sponsor's protocol ID
- Tanzeela Majeed
- Status last verified
- Oct 2024
- First submitted
- 24 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heidari B. Knee osteoarthritis prevalence, risk factors, pathogenesis and features: Part I. Caspian J Intern Med. 2011 Spring;2(2):205-12.
PubMed 24024017Jung JH, Bang CH, Song GG, Kim C, Kim JH, Choi SJ. Knee osteoarthritis and menopausal hormone therapy in postmenopausal women: a nationwide cross-sectional study. Menopause. 2018 Dec 21;26(6):598-602. doi: 10.1097/GME.0000000000001280.
PubMed 30586007
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects Of Dynamic And Static Stretching On Pain, Lower Extremity Function And Knee Range Of Motion In Postmenopausal Females With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06658327
- Acronym / sponsor ID
- Tanzeela Majeed
- Conditions
- Postmenopausal, Knee Osteoarthritis
- Keywords
- Pain, Postmenopausal, knee Osteoarthritis, Dynamic Stretching, Static Stretching
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 26 Oct 2024 (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.
As the aging population continues to grow, there is a pressing need to explore effective interventions to alleviate the symptoms of osteoarthritis, particularly in postmenopausal women who may experience unique challenges. Osteoarthritis (OA) is progressive joint disease characterized by joint inflammation and a reparative bone response and is one of the top five most disabling conditions that affects more than one-third of persons >65 years of age, commonly affecting hands, feet, spine, hips, and knees. Among the various therapeutic modalities, stretching exercises, both dynamic and static, have gained attention for their potential to enhance joint flexibility, reduce pain, and improve functional outcomes.
Detailed description
The study will be a randomized clinical trial and will be conducted in Jinnah Hospital, Mafaza-Tul-Hayat Hospital Lahore and Mayo Hospital Lahore. This study will be completed in time duration of 7 months after the approval of synopsis. Non-probability convenience sampling technique will be used and 58 participants will be recruited in study after randomization. The subjects will be divided into two groups. Group A will receive dynamic stretching of hamstrings and quadriceps with static stretching and Group B will receive dynamic stretching without static stretching after warm up as baseline treatment. The tools that will be used are Osteoarthritis outcome scale Goniometer Lower extremity function scale, Strength, MMT, NPRS, after data collection data will be analyzed by using SPSS version 21
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Dynamic stretchingDynamic stretching |
| Group B | Experimental | Other: Static stretchingStatic Stretching |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 50 to 65
- Diagnosed patients of OA with grade 3
- Multiparous (5 children)
- Fertile females
- Pain greater than 6 on NPRS
Key exclusion criteria (4 listed)
- BMI > 30
- Early menarche ≤10 or 11 years.
- Cancer i.e breast cancer ,Ovrian cancer
- Any bone deformity before menopause i.e limb length discrepancy, angulation
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 |
|---|---|---|
| Dynamic stretchingGroup A will receive 2*10 repetitions of dynamic stretching of hamstrings and calf muscles in standing position after application of hot pack (standard size which had been stored in a hydro collator tank of 74.5-80°C for 30 minutes) with 6-8 layers of towel was applied on lower extremity for 10 minutes The subjects will be asked to stand upright with their feet parallel and facing forward with hands holding onto something. Each treatment session will last for 30 minutes. The protocol will be repeated every day for 5 days from the first day of treatment. | Other | Group A |
| Static stretchingGroup B will receive 2*10 repetitions of static stretching of hamstrings and quads in standing position after application of hot pack (standard size which had been stored in a hydro collator tank of 74.5-80°C for 30 minutes) with 6-8 layers of towel was applied on lower extremity for 10 minutes. The subjects will be asked to stand upright with their feet parallel and facing forward with hands holding onto something. Each treatment session will last for 30 minutes. The protocol will be repeated every day for 5 days from the first day of treatment. | Other | Group B |
Primary outcome
GONIOMETER
Time frame: 6 Weeks
Goniometer is a device used to measure joint ranges. Goniometric measurement of ROM is an important part of clinical examination in osteoarthritis knee and can give information about available knee joint motion, guide about pattern of management, and prognosis.
LOWER EXTREMITY FUNCTION SCALE
Time frame: 6 Weeks
The LEFS scores demonstrated excellent test-retest reliability (intraclass correlation coefficients ranging between 0.85 and 0.99) and demonstrated the expected relationships with measures assessing similar constructs.
STRENGTH MMT
Time frame: 6 Weeks
MMT is the most commonly used method for documenting impairments in muscle strength. Manual muscle testing is used in rehabilitation and recovery to evaluate contractile units, including muscles and tendons, and their ability to generate forces.
Numerical Pain Rating Scale
Time frame: 6 Weeks
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain.
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 26 Oct 2024.
- Background: PubMed 24024017Heidari B. Knee osteoarthritis prevalence, risk factors, pathogenesis and features: Part I. Caspian J Intern Med. 2011 Spring;2(2):205-12.
- Background: PubMed 30586007Jung JH, Bang CH, Song GG, Kim C, Kim JH, Choi SJ. Knee osteoarthritis and menopausal hormone therapy in postmenopausal women: a nationwide cross-sectional study. Menopause. 2018 Dec 21;26(6):598-602. doi: 10.1097/GME.0000000000001280.
- 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.
Tanzeela Majeed, MS principal investigator
Ripah International university, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic stretching and Static stretching in people with Postmenopausal and 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 4 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 26 Oct 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 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 Adeela Arif, Mphil (03320845723, adeela.arif@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GONIOMETER (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?
On the ClinicalTrials.gov record for NCT06658327, which also lists 2 linked publications.
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 26 Oct 2024.