NCT02936336

Brief Summary

Osteoporosis is a serious global health problem, second only to cardiovascular disease. Osteoporosis is the most common metabolic bone disease in the elderly population, characterized by loss of bone mineral density (BMD) and continuous destruction of bone microstructure, especially in postmenopausal women. It gives rise to bone fragility and fracture risk. Moreover, as people grow older, falls frequently occur with high severity, and nearly 35% to 45% of persons aged 65 or older fall at least once a year. Osteoporotic fractures increase mortality, morbidity, chronic pain, and the cost of social care and it decreases the quality of life. Here, investigators plan to perform different exercise interventions such as circuit exercise, aerobic dance and Tai Chi on the community's older adults to evaluate whether exercise intervention could improve the bone mineral density, physical fitness, muscle strength or quality of life.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
411

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
Last Updated

May 14, 2018

Status Verified

May 1, 2018

Enrollment Period

4.1 years

First QC Date

October 13, 2016

Last Update Submit

May 11, 2018

Conditions

Metabolic Disease

Outcome Measures

Primary Outcomes (1)

  • Change from baseline bone mineral density

    Bone mineral density measurement is measured by dual-energy x-ray absorptiometry (DXA). Measurements are made over the lumbar spine and over the upper part of the hip and the measurement is assessed at Pre-intervention, 3-month, 6-month, 9-month-follow-up.

    Pre-intervention, 3-month, 6-month, 9-month-follow-up

Secondary Outcomes (12)

  • Change from baseline elbow muscle strength

    Pre-intervention, 3-month, 6-month, 9-month-follow-up

  • Change from baseline shoulder muscle strength

    Pre-intervention, 3-month, 6-month, 9-month-follow-up

  • Change from baseline hip muscle strength

    Pre-intervention, 3-month, 6-month, 9-month-follow-up

  • Change from baseline knee muscle strength

    Pre-intervention, 3-month, 6-month, 9-month-follow-up

  • Change from baseline SF-36 questionnaire assessment

    Pre-intervention, 3-month, 6-month, 9-month-follow-up

  • +7 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

without exercise intervention

Exercise

EXPERIMENTAL

Subjects with circuit exercise, aerobic dance, or Tai Chi exercise intervention.

Other: exercise

Interventions

exerciseOTHER

circuit exercise, aerobic dance and Tai Chi exercise

Exercise

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being \>45 years-of-age,
  • Healthy and physically independent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sports Medicine Center, Chang Gung Memorial Hospital

Pizi, 613, Taiwan

Location

Related Publications (1)

  • Hsu WH, Hsu WB, Fan CH, Hsu RW. Predicting osteoporosis with body compositions in postmenopausal women: a non-invasive method. J Orthop Surg Res. 2021 Mar 24;16(1):215. doi: 10.1186/s13018-021-02351-3.

    PMID: 33761975DERIVED

MeSH Terms

Conditions

Metabolic Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Robert Wen-Wei HSU, MD

    Sports Medicine Center, Chang Gung Memorial Hospital, Chiayi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Honorary Dean

Study Record Dates

First Submitted

October 13, 2016

First Posted

October 18, 2016

Study Start

November 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

May 14, 2018

Record last verified: 2018-05

Locations

TW(1)