Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06445842
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-31
Brief Title:
Short-term Circuit Training on Muscle Mass and Quality of Life in Sedentary Postmenopausal Women
Sponsor:
Loma Linda University
Organization:
Loma Linda University
Study Overview
Official Title:
The Effects of Short-Term Circuit Strength Training Intervention on Muscle Mass Metabolic Health Balance Quality of Life and Inflammaging in Sedentary Postmenopausal Women
Status:
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:
None
Brief Summary:
The purpose of this graduate student research study is to provide healthcare professionals with evidence of the potential of circuit strength training in improving the physical and psychosocial well-being of postmenopausal women
Detailed Description:
A randomized controlled trial design will investigate the effects of circuit training on the following dependent variables muscle mass strength inflammatory markers balance functional capacity and quality of life
Body composition measurements will utilize IN-BODY technology The Motor Control Screen Lower Body MCS will determine balance For assessing strength we will use the Dynamometer specifically for grip strength Ultrasound will gauge muscle mass while the BTE Baltimore Therapeutic Equipment will handle quadriceps isometric muscle tests The Peak Expiratory Flow PEF will evaluate respiratory strength Participants aerobic capacity will be gauged via the 6-minute Walk Test Heart Rate Variability HRV evaluations will rely on Polar devices and the Fitbit Inspire3 We will also employ the Fitbit Inspire3for tracking sleep quality Psychosocial factors will be examined through Falls Efficacy Scale-International FES-I SF-36 QOL Questionnaire PHQ-ADS and the Pittsburgh Sleep Quality Index PSQI Activity levels will be determined through the IPAQ-SF questionnaire The questionnaires will be completed on Qualtrics or in hardcopy format Blood tests will monitor inflammatory markers such as IL-6 TNF-α and hs-CRP The study will be conducted over 10 weeks starting from the initial and final data collection During the first week participants will need to visit the research laboratory to undergo basic tests After completing all procedures including informed consent and blood collection participants will be randomly assigned computerized generated to the experimental exercise group N18 or control non-exercise group N18
In the first week the exercise group will participate for two additional days to introduce the exercise evaluate their movements and determine their maximum exercise capacity The experimental group will participate in circuit strength training sessions lasting approximately 45 minutes three times a week for 8 weeks The exercise protocol will consist of a 10-minute warm-up and cool-down two sets of 12-minute high-intensity circuit training exercises and a 3-minute break between sets The intensity of the exercises will be gradually increased every two weeks for 8 weeks
Meanwhile the control group will need to maintain their sedentary lifestyle without changing their activity levels or diet
After completing the 8-week exercise protocol all participants will visit the lab for a second round of data collection Additionally the exercise protocol will be shown to the control group during the retest day of the study
Body composition measurements will utilize IN-BODY technology The Motor Control Screen Lower Body MCS will determine balance For assessing strength we will use the Dynamometer specifically for grip strength Ultrasound will gauge muscle mass while the BTE Baltimore Therapeutic Equipment will handle quadriceps isometric muscle tests The Peak Expiratory Flow PEF will evaluate respiratory strength Participants aerobic capacity will be gauged via the 6-minute Walk Test Heart Rate Variability HRV evaluations will rely on Polar devices and the Fitbit Inspire3 We will also employ the Fitbit Inspire3for tracking sleep quality Psychosocial factors will be examined through Falls Efficacy Scale-International FES-I SF-36 QOL Questionnaire PHQ-ADS and the Pittsburgh Sleep Quality Index PSQI Activity levels will be determined through the IPAQ-SF questionnaire The questionnaires will be completed on Qualtrics or in hardcopy format Blood tests will monitor inflammatory markers such as IL-6 TNF-α and hs-CRP The study will be conducted over 10 weeks starting from the initial and final data collection During the first week participants will need to visit the research laboratory to undergo basic tests After completing all procedures including informed consent and blood collection participants will be randomly assigned computerized generated to the experimental exercise group N18 or control non-exercise group N18
In the first week the exercise group will participate for two additional days to introduce the exercise evaluate their movements and determine their maximum exercise capacity The experimental group will participate in circuit strength training sessions lasting approximately 45 minutes three times a week for 8 weeks The exercise protocol will consist of a 10-minute warm-up and cool-down two sets of 12-minute high-intensity circuit training exercises and a 3-minute break between sets The intensity of the exercises will be gradually increased every two weeks for 8 weeks
Meanwhile the control group will need to maintain their sedentary lifestyle without changing their activity levels or diet
After completing the 8-week exercise protocol all participants will visit the lab for a second round of data collection Additionally the exercise protocol will be shown to the control group during the retest day of the study
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