Bone Mineral Density and Bone Metabolism in Older Women

NCT06529172 | Completed DMC

• 2 other identifiers: ChengduSUYouth Found of Humanities and
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis, Age-Related

Keywords

bone mineral density; bone metabolism

Outcome Measures

Primary Outcomes (2)

• Dual-energy X-ray absorptiometry measurements

  A Norland XR-46 dual-energy X-ray BMD tester was used to measure the BMD of the lumbar L2-4 and proximal femur of the dominant side (femur neck, greater trochanter and Ward's triangle). Five non-re-entrant scans were performed at each measurement site. The error coefficients of the measurement location were 1-2% in the lumbar L2-4, femoral neck and greater trochanter and 2.5-5% in Ward's triangle. The coefficient of variation in the lumbar vertebrae and the proximal femur was 1.1% and 1.85%, respectively.

  24 Weeks

• Serum bone metabolism markers

  Fasting venous blood (5 ml) was drawn between 7 a.m. and 8 a.m. at both baseline and after 24 weeks, with samples subsequently centrifuged at 3000 r/min for 5 minutes in each instance. Serum levels of PINP, OC, and β-CTX were measured using an automatic chemiluminescence analyzer, the LIAISON® XL, which is manufactured by the Italian company DiaSorin. The kit required for the experiment was purchased from Nanjing Jiancheng Bioengineering Institute and utilised in strict accordance with its instructions.

  24 Weeks

Secondary Outcomes (1)

• Physical Activity Assessment

  24 Weeks

Study Arms (4)

Control

ACTIVE COMPARATOR

The CG group maintained their original lifestyle without engaging in regular exercise.

Other: Resistance training; Other: Yijinjing; Other: Baduanjing; Other: Control

Resistance training

EXPERIMENTAL

RT group (RG, n = 21), YJJ group (YG, n = 22), BDJ group (BG, n = 21). These groups performed the assigned exercises for 24 weeks (3 times/week, 60 min/time).

Other: Resistance training; Other: Yijinjing; Other: Baduanjing; Other: Control

Yijinjing

EXPERIMENTAL

RT group (RG, n = 21), YJJ group (YG, n = 22), BDJ group (BG, n = 21). These groups performed the assigned exercises for 24 weeks (3 times/week, 60 min/time).

Other: Resistance training; Other: Yijinjing; Other: Baduanjing; Other: Control

Baduanjing

EXPERIMENTAL

RT group (RG, n = 21), YJJ group (YG, n = 22), BDJ group (BG, n = 21). These groups performed the assigned exercises for 24 weeks (3 times/week, 60 min/time).

Other: Resistance training; Other: Yijinjing; Other: Baduanjing; Other: Control

Interventions

Resistance training OTHER

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 times/sets 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.

Baduanjing; Control; Resistance training; Yijinjing

Yijinjing OTHER

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.

Baduanjing; Control; Resistance training; Yijinjing

Baduanjing OTHER

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.

Baduanjing; Control; Resistance training; Yijinjing

Control OTHER

The CG group maintained their original lifestyle without engaging in regular exercise

Baduanjing; Control; Resistance training; Yijinjing

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females who were aged 60-70 years
• Recently expressed willingness to engage in fitness activities
• Passed a health examination
• Signed an informed consent form in accordance with the Helsinki Declaration were included.

You may not qualify if:

• Heart disease
• History of severe lower limb injury
• A T-score of less than -2.5 standard deviations is diagnostic of osteoporosis
• Currently taking antiosteoporosis medication
• Currently taking hormone replacement therapy
• Engaging in other regular forms of exercise were excluded.

Sponsors & Collaborators

• Cheng Liang: lead
• Chengdu Sport University: collaborator

Study Sites (1)

Chengdu Sport University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Liang Cheng, Dr

  Chengdu Sport University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Pro

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 31, 2024
• Study Start: June 5, 2023
• Primary Completion: January 15, 2024
• Study Completion: January 20, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)