Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06529172
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Bone Mineral Density and Bone Metabolism in Older Women
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Resistance Training Yijinjing and Baduanjin Exercise on Bone Mineral Density and Bone Metabolism in Older Women
Status:
COMPLETED
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:
BMD
Brief Summary:
The objective of this study is to assess the impact of different exercise interventions on bone mineral density BMD in older women It will also evaluate the safety and compliance of these interventions The primary questions it aims to address are
Does resistance training Yijinjing or Baduanjin improve BMD in postmenopausal women What are the compliance rates and any adverse effects associated with these exercise programs Participants will be divided into 4 groups and compared against a control group that maintains their usual lifestyle
Participants will
Engage in their assigned exercise program three times a week for 24 weeks Receive calcium and vitamin D supplementation daily Keep a log of exercise adherence and any side effects experienced The study will utilize the International Physical Activity Questionnaire and dual-energy X-ray absorptiometry for comprehensive assessments
Does resistance training Yijinjing or Baduanjin improve BMD in postmenopausal women What are the compliance rates and any adverse effects associated with these exercise programs Participants will be divided into 4 groups and compared against a control group that maintains their usual lifestyle
Participants will
Engage in their assigned exercise program three times a week for 24 weeks Receive calcium and vitamin D supplementation daily Keep a log of exercise adherence and any side effects experienced The study will utilize the International Physical Activity Questionnaire and dual-energy X-ray absorptiometry for comprehensive assessments
Detailed Description:
The calculation revealed that a minimum number of 80 participants was required In this study the investigators employed a straightforward randomization method for group allocation This study designated four sets of cards numbered 1 to 4 with each number representing one of the groups RT group RG YJJ group YG BDJ group BG and control group CG Each set included 23 cards and participants were assigned to groups using a draw from these sets ensuring random and equal distribution across groups
Participants were required to engage in exercise sessions conducted in a centralized manner with three 60-minute sessions per week The investigators did indeed monitor and document the compliance of the participants Compliance encompassed adherence to the exercise regimen intake of supplements and compliance with all other research requirements The majority of participants demonstrated good compliance throughout the 24-week study period
Exercise intervention The initial exercise intervention was provided as follows throughout the entire intervention period the four groups of participants were administered calcium and vitamin D supplementation produced by Wyeth Pharmaceuticals specification 600 mg per tablet National Medicine Permission No H10950029 once in the morning and once in the evening one tablet each time During the intervention period participants were advised to avoid smoking and the consumption of alcohol coffee strong tea and carbonated drinks The CG group maintained their original lifestyle without engaging in regular exercise The intervention period lasted for 24 weeks with a frequency of three times per week Each session lasted for 60 min and included approximately 10 min of preparatory activities warm-up and relaxation Exercise intensity was based on the research method by Cheng et al with the heart rate controlled at 220 - age 55 to 70 After each exercise session the carotid pulse was recorded by manually counting the beats over a 30-second period post-exercise using this data to adjust the exercise intensity if it deviated from the target heart rate range
RG performed RT with an elastic band yellow force of 9-11 pounds when stretched twice the original length They performed eight movements Each movement was performed for 3-5 sets at 8 timessets with 30 s of rest between groups The movements included upright rows reverse curls standing shoulder rotations neck-elbow extensions elbow bends downward lunges standing leg lifts side lifts and standing back kicks All participants completed the RT movements according to the regular rhythm 1-2-1 provided by the experimenter which ensured that all participants had similar movements completion rates
YG performed 12 movements These movements included extending the hands upwards and slowly lowering them extending the torso by stretching the hands straight up and bending the body to the left or right squatting with the hands on the knees and standing up slowly bending the body to the left or right side extending the arms and waist getting down on the knees leaning forward extending the hands forward and slowly pulling them back bending forward placing the hands around the knees and standing up slowly placing the hands on the hips and leaning back to stretch the back and waist
BG performed eight movements These movements included holding the hands straight up slowly bringing the hands down and turning the waist while in a standing position bending the body to the left or right side and extending the arms extending one hand straight up placing the other hand on the waist then switching arms and repeating the movement tilting the head back and looking back while stretching the neck and back squatting the body swinging the head and hips from side to side and moving the spine and waist bending the body forward touching the hands to the toes and standing up slowly making fists with the hands and moving the arms and shoulders and gently bouncing the body to relax the whole body in a standing position
The first 4 weeks of YG and BG were the learning period and weeks 5-24 weeks were the consolidation and strengthening period During the consolidation and strengthening period the participants were required to practise six sets of movements each time with a gap of approximately 30 s With the increase in intervention weeks the participants can appropriately adjust the stretching length of the elastic band and increase the number of sets to control the load in accordance with their own condition The experimenter conducted weekly interviews in person or via telephone using a standardized questionnaire to document all participants39 living conditions The recorded information mainly involved the participants39 eating habits diet variety and amount working and resting patterns sleep quality sunshine amount and residence area whether the participants took other regular exercise and whether the participants took drugs that affected BMD Diet and Lifestyle Interview Findings This study found that participants largely adhered to their regular dietary habits and physical activity levels throughout the study This consistency suggests that these factors were not significant confounders affecting the study outcomes
Participants were required to engage in exercise sessions conducted in a centralized manner with three 60-minute sessions per week The investigators did indeed monitor and document the compliance of the participants Compliance encompassed adherence to the exercise regimen intake of supplements and compliance with all other research requirements The majority of participants demonstrated good compliance throughout the 24-week study period
Exercise intervention The initial exercise intervention was provided as follows throughout the entire intervention period the four groups of participants were administered calcium and vitamin D supplementation produced by Wyeth Pharmaceuticals specification 600 mg per tablet National Medicine Permission No H10950029 once in the morning and once in the evening one tablet each time During the intervention period participants were advised to avoid smoking and the consumption of alcohol coffee strong tea and carbonated drinks The CG group maintained their original lifestyle without engaging in regular exercise The intervention period lasted for 24 weeks with a frequency of three times per week Each session lasted for 60 min and included approximately 10 min of preparatory activities warm-up and relaxation Exercise intensity was based on the research method by Cheng et al with the heart rate controlled at 220 - age 55 to 70 After each exercise session the carotid pulse was recorded by manually counting the beats over a 30-second period post-exercise using this data to adjust the exercise intensity if it deviated from the target heart rate range
RG performed RT with an elastic band yellow force of 9-11 pounds when stretched twice the original length They performed eight movements Each movement was performed for 3-5 sets at 8 timessets with 30 s of rest between groups The movements included upright rows reverse curls standing shoulder rotations neck-elbow extensions elbow bends downward lunges standing leg lifts side lifts and standing back kicks All participants completed the RT movements according to the regular rhythm 1-2-1 provided by the experimenter which ensured that all participants had similar movements completion rates
YG performed 12 movements These movements included extending the hands upwards and slowly lowering them extending the torso by stretching the hands straight up and bending the body to the left or right squatting with the hands on the knees and standing up slowly bending the body to the left or right side extending the arms and waist getting down on the knees leaning forward extending the hands forward and slowly pulling them back bending forward placing the hands around the knees and standing up slowly placing the hands on the hips and leaning back to stretch the back and waist
BG performed eight movements These movements included holding the hands straight up slowly bringing the hands down and turning the waist while in a standing position bending the body to the left or right side and extending the arms extending one hand straight up placing the other hand on the waist then switching arms and repeating the movement tilting the head back and looking back while stretching the neck and back squatting the body swinging the head and hips from side to side and moving the spine and waist bending the body forward touching the hands to the toes and standing up slowly making fists with the hands and moving the arms and shoulders and gently bouncing the body to relax the whole body in a standing position
The first 4 weeks of YG and BG were the learning period and weeks 5-24 weeks were the consolidation and strengthening period During the consolidation and strengthening period the participants were required to practise six sets of movements each time with a gap of approximately 30 s With the increase in intervention weeks the participants can appropriately adjust the stretching length of the elastic band and increase the number of sets to control the load in accordance with their own condition The experimenter conducted weekly interviews in person or via telephone using a standardized questionnaire to document all participants39 living conditions The recorded information mainly involved the participants39 eating habits diet variety and amount working and resting patterns sleep quality sunshine amount and residence area whether the participants took other regular exercise and whether the participants took drugs that affected BMD Diet and Lifestyle Interview Findings This study found that participants largely adhered to their regular dietary habits and physical activity levels throughout the study This consistency suggests that these factors were not significant confounders affecting the study outcomes
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