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Osteoporosis, Age-RelatedBMDNCT06529172

Bone Mineral Density and Bone Metabolism in Older Women

A study testing Resistance training, Yijinjing and Baduanjing in people with Osteoporosis, Age-Related, run by Cheng Liang at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for
Osteoporosis, Age-Related
What is being tested?
Resistance training, Yijinjing and Baduanjing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
1 siteChina
Study dates
5 Jun 2023to 20 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Chengdu Sport University

    Chengdu, Sichuan, 610041

Other trials in China

About this study

Official title: Effects of Resistance Training, Yijinjing and Baduanjin Exercise on Bone Mineral Density and Bone Metabolism in Older Women

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.

Read more

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.

Read the 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 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.

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 participants\' living conditions. The recorded information mainly involved the participants\' 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.

Being tested
Resistance training, Yijinjing, Baduanjing, Control
Keywords
bone mineral density, bone metabolism
Medical subject headings
Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resistance trainingOther

    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.

  • YijinjingOther

    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.

  • BaduanjingOther

    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.

  • ControlOther

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

Study groups in NCT06529172
Study groupRoleWhat they receive
ControlActive comparatorThe CG group maintained their original lifestyle without engaging in regular exercise.
Receives: Other: Resistance training; Other: Yijinjing; Other: Baduanjing; Other: Control
Resistance trainingExperimentalRT 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).
Receives: Other: Resistance training; Other: Yijinjing; Other: Baduanjing; Other: Control
YijinjingExperimentalRT 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).
Receives: Other: Resistance training; Other: Yijinjing; Other: Baduanjing; Other: Control
BaduanjingExperimentalRT 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).
Receives: Other: Resistance training; Other: Yijinjing; Other: Baduanjing; Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 24 Weeks

  2. 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.

    Measured: 24 Weeks

Secondary outcomes (1)
  1. Physical Activity Assessment

    This study incorporated a validated assessment tool to monitor the participants' physical activity levels. For all groups, we utilized the International Physical Activity Questionnaire (IPAQ)

    Measured: 24 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2024
  2. Study start5 Jun 2023
  3. Primary completion15 Jan 2024
  4. Study completion20 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06529172
Sponsor's protocol ID
ChengduSU
Other IDs
Youth Found of Humanities and
Acronym
BMD
Status last verified
Jul 2024
First submitted
25 Jul 2024
Last updated
31 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Resistance training, Yijinjing and Baduanjing in people with Osteoporosis, Age-Related, run by Cheng Liang at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dual-energy X-ray absorptiometry measurements (time frame: 24 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.

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