Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06173193
Status:
RECRUITING
Last Update Posted:
2023-12-15
First Post:
2023-10-31
Brief Title:
Effects of Multicomponent Exercise on Subchondral Bone and Cartilage in Postmenopausal Women With Knee Osteoarthritis
Sponsor:
University of Jyvaskyla
Organization:
University of Jyvaskyla
Study Overview
Official Title:
Effects of a Multicomponent Exercise Regimen on Subchondral Bone Cartilage and Inflammation Markers in Postmenopausal Women With Knee Osteoarthritis A Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LuRu2
Brief Summary:
Today osteoarthritis OA is considered a whole-organ disease that is amenable to prevention and treatment in the early stages Information on the articular cartilage and subchondral bone responses to exercise may help to develop safe and feasible exercise programs which can potentially improve cartilage and bone properties Therefore the goal of this study is to produce the knowledge needed to understand what effects multicomponent exercise regimen have on subchondral bone and articular cartilage of the knee joint in postmenopausal women with knee OA
Participants will be randomized into either
1 Intervention group which conducts multicomponent exercise regimen including alternating step-aerobic and resistance training
2 Reference group which represents the standard rehabilitative management for knee OA patients with home exercises
Researchers will compare intervention and reference groups to see if subchondral bone morphology and properties and cartilage biochemical alterations differ between the groups at the end of the 8-month intervention and 12-month follow-up period
Participants will be randomized into either
1 Intervention group which conducts multicomponent exercise regimen including alternating step-aerobic and resistance training
2 Reference group which represents the standard rehabilitative management for knee OA patients with home exercises
Researchers will compare intervention and reference groups to see if subchondral bone morphology and properties and cartilage biochemical alterations differ between the groups at the end of the 8-month intervention and 12-month follow-up period
Detailed Description:
The study is an 8-month randomized controlled intervention study with 12-month follow-up in volunteer postmenopausal 55-75-year-old women with mild radiographic knee OA according to the Kellgren-Lawrence classification grade 1-2 The participants will be randomly assigned into the subgroups The study will be conducted in two phases
8-month multicomponent exercise regimen will be carried out gradually and progressively three times a week by experienced and recently trained exercise instructors The instructors will keep an attendance and an adverse event record for each of the intervention groups participants The home exercises carried out three times a week by the reference group represent the standard rehabilitative management for knee OA patients
In addition to the above-mentioned treatments all participants will receive instructions to use paracetamol on an as-needed basis Participants will be called to end-point measurements at 8 months after baseline and follow-up measurements at 20 months after baseline
The overall goal of this study is to produce the knowledge needed to understand what effects multicomponent exercise regimen have on subchondral bone and articular cartilage of the knee joint in postmenopausal women with knee OA In addition the aim is to develop means to improve functional competence as well as to prevent physical disability among women suffering from knee OA Specifically the objectives are to investigate the effects of joint loading exercise regimen on knee joint subchondral bone morphology and properties and cartilage biochemical alterations and their 12 month maintenance in women with knee OA Also training effects on molecular biomarkers related to OA and inflammation bone traits physical function performance body composition and clinically important symptoms will be examined
8-month multicomponent exercise regimen will be carried out gradually and progressively three times a week by experienced and recently trained exercise instructors The instructors will keep an attendance and an adverse event record for each of the intervention groups participants The home exercises carried out three times a week by the reference group represent the standard rehabilitative management for knee OA patients
In addition to the above-mentioned treatments all participants will receive instructions to use paracetamol on an as-needed basis Participants will be called to end-point measurements at 8 months after baseline and follow-up measurements at 20 months after baseline
The overall goal of this study is to produce the knowledge needed to understand what effects multicomponent exercise regimen have on subchondral bone and articular cartilage of the knee joint in postmenopausal women with knee OA In addition the aim is to develop means to improve functional competence as well as to prevent physical disability among women suffering from knee OA Specifically the objectives are to investigate the effects of joint loading exercise regimen on knee joint subchondral bone morphology and properties and cartilage biochemical alterations and their 12 month maintenance in women with knee OA Also training effects on molecular biomarkers related to OA and inflammation bone traits physical function performance body composition and clinically important symptoms will be examined
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 351483 | OTHER_GRANT | Academy of Finland | None |