Ignite Creation Date:
2024-07-17 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480643
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-17
Brief Title:
Effect of Exercise Type on Muscle Quality in Patients With OA SARC and RA an Explorative Study
Sponsor:
Amsterdam UMC location VUmc
Organization:
Amsterdam UMC location VUmc
Study Overview
Official Title:
Effect of Exercise Type on Muscle Quality in Patients With OA SARC and RA an Explorative Study The Care for Muscle Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
C4M
Brief Summary:
C4M hypothesizes that patients with low muscle strength may respond differently to different types of exercise intervention dependent on the underlying aetiology ie impaired protein synthesis versus metabolic dysfunction and that this response is predictable based on the clinical diagnosis ie rheumatoid arthritis RA osteoarthritis OA and Sarcopenia alone SARC and a number of clinical blood based and muscle metabolic and architectural biomarkers Understanding the underlying biochemical response of each patient group to the different type of exercise loading could help with the development of disease-specific training making it more effective and more predictable on outcomes
Detailed Description:
Rationale C4M hypothesizes that patients with low muscle strength may respond differently to different types of exercise intervention dependent on the underlying aetiology ie impaired protein synthesis versus metabolic dysfunction and that this response is predictable based on the clinical diagnosis ie rheumatoid arthritis RA osteoarthritis OA and Sarcopenia alone SARC and a number of clinical blood based and muscle metabolic and architectural biomarkers Understanding the underlying biochemical response of each patient group to the different type of exercise loading could help with the development of disease-specific training making it more effective and more predictable on outcomes
Objective to explore effectivity interaction and predictability of two types of exercise intervention in patients with RA OA and SARC alone The primary outcome of this study will be isokinetic muscle strength of the quadriceps in all three target groups
Study design two-arm parallel-group exploratory trial including a total of 69 patients study population 23 patients with OA 23 patients with RA and 23 patients with SARC alone according to the revised European Working Group on Sarcopenia in Older People consensus definition EWGSOP-II criteria Cruz- Jentoft 2019
Intervention Exercise intervention for 3 times a week for 8 weeks
Main study parametersendpoints the main study parameter is the difference in isokinetic muscle strength pre- and post-intervention in all three patient groups The secondary study parameters include muscle endurance mitochondrial respiration gene and protein expression and histology via muscle biopsies inflammation via bloodwork and feasibility
Intervention Exercise intervention for 3 times a week for 8 weeks
Main study parametersendpoints the main study parameter is the difference in isokinetic muscle strength pre- and post-intervention in all three patient groups The secondary study parameters include muscle endurance mitochondrial respiration gene and protein expression and histology via muscle biopsies inflammation via bloodwork and feasibility
Objective to explore effectivity interaction and predictability of two types of exercise intervention in patients with RA OA and SARC alone The primary outcome of this study will be isokinetic muscle strength of the quadriceps in all three target groups
Study design two-arm parallel-group exploratory trial including a total of 69 patients study population 23 patients with OA 23 patients with RA and 23 patients with SARC alone according to the revised European Working Group on Sarcopenia in Older People consensus definition EWGSOP-II criteria Cruz- Jentoft 2019
Intervention Exercise intervention for 3 times a week for 8 weeks
Main study parametersendpoints the main study parameter is the difference in isokinetic muscle strength pre- and post-intervention in all three patient groups The secondary study parameters include muscle endurance mitochondrial respiration gene and protein expression and histology via muscle biopsies inflammation via bloodwork and feasibility
Intervention Exercise intervention for 3 times a week for 8 weeks
Main study parametersendpoints the main study parameter is the difference in isokinetic muscle strength pre- and post-intervention in all three patient groups The secondary study parameters include muscle endurance mitochondrial respiration gene and protein expression and histology via muscle biopsies inflammation via bloodwork and feasibility
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