Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06535425
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
Participants With Knee Osteoarthrosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Platelet-Rich Plasma Combined With Isometric Contractions of Quadriceps on Symptoms Postural Control Mobility and Inflammatory Markers in Participants With Knee Osteoarthrosis
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KOA
Brief Summary:
Title Efficacy and Safety Trial of PRP and ICQ for Elderly Women with KOA
Goal
To assess if PRP and ICQ reduce symptoms and improve mobility in elderly women with knee osteoarthritis
Key Questions
Does PRP and ICQ decrease symptom severity as measured by WOMAC What side effects occur from PRP and ICQ intervention
Participants
Elderly women aged 60-70 with KOA
Intervention
PRP injection and ICQ exercises for 16 weeks
Procedure
Daily PRP or placebo for 4 months Bi-weekly clinic visits for assessments Weekly health education and lifestyle monitoring
Measurements
WOMAC scores physical mobility tests and serum biomarkers before and after intervention
Ethics
Approved by Chengdu Sport University39s Ethics Committee
Sample Size
80 participants needed
Randomization
Random assignment to PRP ICQ or control groups
This trial aims to determine the benefits and risks of PRP and ICQ in treating KOA in elderly women
Goal
To assess if PRP and ICQ reduce symptoms and improve mobility in elderly women with knee osteoarthritis
Key Questions
Does PRP and ICQ decrease symptom severity as measured by WOMAC What side effects occur from PRP and ICQ intervention
Participants
Elderly women aged 60-70 with KOA
Intervention
PRP injection and ICQ exercises for 16 weeks
Procedure
Daily PRP or placebo for 4 months Bi-weekly clinic visits for assessments Weekly health education and lifestyle monitoring
Measurements
WOMAC scores physical mobility tests and serum biomarkers before and after intervention
Ethics
Approved by Chengdu Sport University39s Ethics Committee
Sample Size
80 participants needed
Randomization
Random assignment to PRP ICQ or control groups
This trial aims to determine the benefits and risks of PRP and ICQ in treating KOA in elderly women
Detailed Description:
Clinical Trial on the Efficacy and Safety of Platelet-Rich Plasma PRP and Isometric Contraction Quadriceps ICQ Intervention in Elderly Female Patients with Knee Osteoarthritis KOA
Objective
The primary objective of this clinical trial is to evaluate the effectiveness and safety of Platelet-Rich Plasma PRP combined with Isometric Contraction Quadriceps ICQ intervention in treating knee osteoarthritis in elderly female patients The study aims to answer the following questions
Does the combination of PRP and ICQ reduce the severity of KOA symptoms as measured by the Western Ontario and McMaster Universities Osteoarthritis Index WOMAC What are the potential side effects or complications associated with the PRP and ICQ intervention in elderly patients
Study Design
The trial will be a randomized controlled trial comparing the effects of PRP and ICQ intervention with those of a control group Participants will be randomly assigned to one of four groups PRP group ICQ group joint group receiving both PRP and ICQ or control group
Participants
Elderly female patients diagnosed with KOA aged between 60 and 70 years will be recruited from the Sichuan Provincial Peoples Hospital The inclusion and exclusion criteria will be strictly followed to ensure the homogeneity and reliability of the study population
Intervention
Participants in the PRP and joint groups will receive an injection of autologous PRP at baseline The PRP will be prepared from venous blood using a low-speed centrifuge Participants in the ICQ and joint groups will undergo a 16-week ICQ intervention performing isometric contractions and relaxations of the quadriceps muscle five times per week
Procedure
Participants will receive either PRP injection or a placebo for the control group at baseline
They will undergo a 16-week ICQ intervention if assigned to the ICQ or joint group
Participants will be required to attend weekly health education sessions for the first month
They will be followed up weekly through calls or interviews to monitor their adherence to the intervention and to ensure they maintain their usual lifestyle habits
Assessment
KOA symptoms will be evaluated using the WOMAC index at baseline and at the end of the 16th week
Physical mobility will be assessed using the 6-minute walk test 6MWT time up and go test TUG and time up and down stairs TUDS at baseline and at the end of the intervention
Serum levels of inflammation markers and matrix metalloproteinases-13 MMP-13 will be measured at baseline and post-intervention
Outcome Measures
Primary outcomes will include changes in WOMAC scores and physical mobility tests
Secondary outcomes will include serum levels of TNF-α IL-1β and MMP-13
Ethical Considerations
The study is approved by the Human Ethics Committee of Chengdu Sport University and informed consent will be obtained from all participants The study will adhere to the Declaration of Helsinki
Sample Size Calculation
Based on a 4 group 3 measurement occasions design with an estimated dropout rate of approximately 15 an effect size of 03 a power of 08 and a significance level of 005 a minimum sample size of 80 participants is determined to be necessary
Randomization
A total of 92 participants will be recruited and randomly assigned to the four groups using a digital randomization method
Data Analysis
Data will be analyzed using appropriate statistical methods to compare the outcomes between the intervention and control groups as well as among the different intervention groups
This clinical trial aims to provide evidence-based insights into the efficacy and safety of PRP and ICQ interventions in managing KOA in elderly female patients
Objective
The primary objective of this clinical trial is to evaluate the effectiveness and safety of Platelet-Rich Plasma PRP combined with Isometric Contraction Quadriceps ICQ intervention in treating knee osteoarthritis in elderly female patients The study aims to answer the following questions
Does the combination of PRP and ICQ reduce the severity of KOA symptoms as measured by the Western Ontario and McMaster Universities Osteoarthritis Index WOMAC What are the potential side effects or complications associated with the PRP and ICQ intervention in elderly patients
Study Design
The trial will be a randomized controlled trial comparing the effects of PRP and ICQ intervention with those of a control group Participants will be randomly assigned to one of four groups PRP group ICQ group joint group receiving both PRP and ICQ or control group
Participants
Elderly female patients diagnosed with KOA aged between 60 and 70 years will be recruited from the Sichuan Provincial Peoples Hospital The inclusion and exclusion criteria will be strictly followed to ensure the homogeneity and reliability of the study population
Intervention
Participants in the PRP and joint groups will receive an injection of autologous PRP at baseline The PRP will be prepared from venous blood using a low-speed centrifuge Participants in the ICQ and joint groups will undergo a 16-week ICQ intervention performing isometric contractions and relaxations of the quadriceps muscle five times per week
Procedure
Participants will receive either PRP injection or a placebo for the control group at baseline
They will undergo a 16-week ICQ intervention if assigned to the ICQ or joint group
Participants will be required to attend weekly health education sessions for the first month
They will be followed up weekly through calls or interviews to monitor their adherence to the intervention and to ensure they maintain their usual lifestyle habits
Assessment
KOA symptoms will be evaluated using the WOMAC index at baseline and at the end of the 16th week
Physical mobility will be assessed using the 6-minute walk test 6MWT time up and go test TUG and time up and down stairs TUDS at baseline and at the end of the intervention
Serum levels of inflammation markers and matrix metalloproteinases-13 MMP-13 will be measured at baseline and post-intervention
Outcome Measures
Primary outcomes will include changes in WOMAC scores and physical mobility tests
Secondary outcomes will include serum levels of TNF-α IL-1β and MMP-13
Ethical Considerations
The study is approved by the Human Ethics Committee of Chengdu Sport University and informed consent will be obtained from all participants The study will adhere to the Declaration of Helsinki
Sample Size Calculation
Based on a 4 group 3 measurement occasions design with an estimated dropout rate of approximately 15 an effect size of 03 a power of 08 and a significance level of 005 a minimum sample size of 80 participants is determined to be necessary
Randomization
A total of 92 participants will be recruited and randomly assigned to the four groups using a digital randomization method
Data Analysis
Data will be analyzed using appropriate statistical methods to compare the outcomes between the intervention and control groups as well as among the different intervention groups
This clinical trial aims to provide evidence-based insights into the efficacy and safety of PRP and ICQ interventions in managing KOA in elderly female patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None