Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532851
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
The Effect of Therapeutic Exercise on Cartilage Morphology and Physical Function for Individuals at High Risk of Knee Osteoarthritis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Efficacy of Progressive Resistance Exercises Versus Aerobic Exercises on Cartilage Morphology and Physical Function in Patients With Degenerative Meniscus Tear A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
This randomized controlled trial aims to evaluate the efficacy of progressive resistance exercises PRE versus aerobic exercises on cartilage morphology and physical function in patients with degenerative meniscus tears 54 participants aged 35-55 will be randomly assigned to one of three groups PRE aerobic exercise or control standard of care physical and medical therapy The study will utilize MRI T2 mapping to assess changes in cartilage composition and patient-reported and performance-based measures to evaluate clinical outcomes This pilot study will also determine the feasibility and issues related to recruitment and retention for a larger trial
Detailed Description:
Background Degenerative meniscus tears are common in individuals over 35 and are associated with early stages of knee osteoarthritis OA 12 Metabolic and microstructural changes within the cartilage occur before surface breakdown which can now be detected using advanced MRI techniques such as T2 mapping Exercise therapy specifically progressive resistance and aerobic exercises has shown benefits for knee OA patients but its effects on early cartilage degeneration are poorly understood
Objective The primary objective of this study is to determine the efficacy of PRE and aerobic exercises on the metabolic function and microstructure of cartilage in individuals with degenerative meniscus tears but without radiographic evidence of knee OA Secondary objectives include evaluating the impact of these exercises on clinical outcomes such as pain disability and physical function and assessing the feasibility of recruitment and retention for a larger trial
Methods The study will enroll 54 participants who will be randomized into three groups PRE aerobic exercise and control Each group will undergo a 3-month supervised exercise program MRI scans will be used to measure changes in cartilage composition while clinical outcomes will be assessed using patient-reported and performance-based measures
Intervention Groups
Group 1 PRE Participants will perform progressive resistance exercises focusing on strengthening the quadriceps The exercises will be adjusted based on the Daily Adjustable Progressive Resistance Exercise DAPRE technique
Group 2 Aerobic Exercise Participants will engage in aerobic exercise sessions using a stationary bike aimed at improving cardiovascular fitness and knee joint mobility
Group 3 Control Participants will receive standard of care including general strength and balance exercises as per current clinical guidelines
Assessments
MRI Imaging Advanced MRI techniques T2 mapping will be used at baseline and after 3 months to assess changes in cartilage composition
Clinical Outcomes Patient-reported outcomes will include the Knee Injury and Osteoarthritis Outcome Score KOOS and the International Knee Documentation Committee IKDC score Performance-based outcomes will include the single-leg squat single-leg hop test sit-to-stand on a one-foot test step-up test and Bruce treadmill test
Inclusion Criteria
Adults aged 35-55 years Symptomatic degenerative medial meniscus tears No radiographic evidence of knee OA Kellgren-Lawrence grade 0-1 Ability to provide informed consent Willingness to participate in the exercise intervention
Exclusion Criteria
Existing diagnosis of knee OA Kellgren-Lawrence grade 2 or higher Repairable meniscus injuries or prior meniscus repair Previous knee surgery or significant knee injury within the past 6 months Presence of inflammatory arthritis or other significant comorbidities Contraindications to MRI or inability to participate in exercise programs
Study Outcomes
Primary Outcomes Changes in T2 relaxation times in the cartilage indicating alterations in cartilage composition and health
Secondary Outcomes Improvements in clinical outcomes including pain disability and physical function as measured by KOOS IKDC and performance-based tests
Feasibility Metrics Recruitment rates adherence to the exercise program and retention rates over the study period
Analysis A mixed ANOVA will be used to compare changes in outcomes between groups with adjustments for multiple comparisons Baseline characteristics will be compared using t-tests and chi-square tests
Objective The primary objective of this study is to determine the efficacy of PRE and aerobic exercises on the metabolic function and microstructure of cartilage in individuals with degenerative meniscus tears but without radiographic evidence of knee OA Secondary objectives include evaluating the impact of these exercises on clinical outcomes such as pain disability and physical function and assessing the feasibility of recruitment and retention for a larger trial
Methods The study will enroll 54 participants who will be randomized into three groups PRE aerobic exercise and control Each group will undergo a 3-month supervised exercise program MRI scans will be used to measure changes in cartilage composition while clinical outcomes will be assessed using patient-reported and performance-based measures
Intervention Groups
Group 1 PRE Participants will perform progressive resistance exercises focusing on strengthening the quadriceps The exercises will be adjusted based on the Daily Adjustable Progressive Resistance Exercise DAPRE technique
Group 2 Aerobic Exercise Participants will engage in aerobic exercise sessions using a stationary bike aimed at improving cardiovascular fitness and knee joint mobility
Group 3 Control Participants will receive standard of care including general strength and balance exercises as per current clinical guidelines
Assessments
MRI Imaging Advanced MRI techniques T2 mapping will be used at baseline and after 3 months to assess changes in cartilage composition
Clinical Outcomes Patient-reported outcomes will include the Knee Injury and Osteoarthritis Outcome Score KOOS and the International Knee Documentation Committee IKDC score Performance-based outcomes will include the single-leg squat single-leg hop test sit-to-stand on a one-foot test step-up test and Bruce treadmill test
Inclusion Criteria
Adults aged 35-55 years Symptomatic degenerative medial meniscus tears No radiographic evidence of knee OA Kellgren-Lawrence grade 0-1 Ability to provide informed consent Willingness to participate in the exercise intervention
Exclusion Criteria
Existing diagnosis of knee OA Kellgren-Lawrence grade 2 or higher Repairable meniscus injuries or prior meniscus repair Previous knee surgery or significant knee injury within the past 6 months Presence of inflammatory arthritis or other significant comorbidities Contraindications to MRI or inability to participate in exercise programs
Study Outcomes
Primary Outcomes Changes in T2 relaxation times in the cartilage indicating alterations in cartilage composition and health
Secondary Outcomes Improvements in clinical outcomes including pain disability and physical function as measured by KOOS IKDC and performance-based tests
Feasibility Metrics Recruitment rates adherence to the exercise program and retention rates over the study period
Analysis A mixed ANOVA will be used to compare changes in outcomes between groups with adjustments for multiple comparisons Baseline characteristics will be compared using t-tests and chi-square tests
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