Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02803190
Other study ID # 201604037RINB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2016
Est. completion date December 2023

Study information

Verified date November 2022
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators' previous studies in 2014 and 2015 have demonstrated that among community-dwelling older adults with high osteoporotic fracture risks. many sarcopenia indices can be improved and bone mineral density (BMD) maintained with different exercise programs. In 2016, the investigators aim to determine the effects of 2 exercise interventions on posture corrections and further improvement of sarcopenic indices


Description:

The current study enrolled subjects who already participated in the 2015 study (n=109) at the National Taiwan University Hospital Bei-Hu Branch (NTUHBB). Subjects will be maintained in their original integrated care group (ICG, target n=50) and muscle training group (MTG, target n=50) when possible. If target sample size is not reached, clinic patients are screened for high risk of fall, osteoporosis/fracture by standardized questionnaires or FRAX for enrollments. New participants are randomized into the ICG and MTG groups. Other than assessments provided in 2015, digital photography on posture and low back pain assessments are done in 2016. All participants received a CD-ROM and one hour education on osteoporosis, sarcopenia, frailty, fall prevention, nutrition, low back pain, good posture, and coping strategy and another hour of professional led exercise program with more focus on central muscle groups. ICG subjects received once weekly group exercise while MTG subjects received twice weekly machine-based resistance training on major muscle groups. Major outcomes were muscle mass (measured by bio-impedance analysis), grip strength, walking speed, and lower leg extension power, Chinese version of Oswestry Disability Index v 2.1 score (for low back pain), and spine curve angle (by photography) at baseline and after 12-weeks of intervention.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date December 2023
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender All
Age group 50 Years to 100 Years
Eligibility Inclusion Criteria: 1. older than 50 years of age 2. high risk as defined from one of the following criteria: score=1 on one minute osteoporosis risk questionnaire; 10 year predicted fracture risk=20% for major osteoporotic fracture or =3% for hip fracture from FRAX; fall=2 times in pass 1 year 3. having a bone mineral density test within one year period 4. having the capability to understand the study and complete the study interventions 5. willing to participate for the intervention and study follow ups Exclusion Criteria: 1. People younger than 50 years of age 2. Could not communicate because of hearing, visual, or cognitive problems 3. Unable to stand and walk unaided (walking aids are acceptable)

Study Design


Intervention

Behavioral:
ICG
All participants received a CD-ROM and one hour education on osteoporosis, sarcopenia, frailty, fall prevention, nutrition, low back pain, good posture, and coping strategy and another hour of professional led exercise program with focus on central muscle groups. ICG subjects received once weekly group exercise.
MTG
All participants received a CD-ROM and one hour education on osteoporosis, sarcopenia, frailty, fall prevention, nutrition, low back pain, good posture, and coping strategy and another hour of professional led exercise program on central muscle groups. MTG subjects received twice weekly machine-based resistance training on major and central muscle groups.

Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (2)

Lead Sponsor Collaborator
National Taiwan University Hospital Taiwanese Osteoposis Association, Wang Jhan-Yang Charitable Trust Fund

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lower extremety extensor power Lower extremity extensor power is measured by isokinetic resistance equipment by a tranined research assistant with standarized protocol.
We will compare the statistical properties between baseline and after 12 weeks intervention.
baseline and 12 weeks
Secondary appendicular skeletal muscle index Measured by bioimpedence analysis machine, before and after intervention. We will compare the statistical properties between baseline and after 12 weeks intervention. baseline and 12 weeks
Secondary grip strength Measured by dynamometer, before and after intervention. We will compare the statistical properties of between baseline and after 12 weeks intervention. baseline and 12 weeks
Secondary walking speed Measured before and after intervention. Subjects are asked to walk 9 meters. The time between 2 and 7 meter mark are recorded. Walking speed is defined as meter/sec We will compare the statistical properties between baseline and after 12 weeks intervention. baseline and 12 weeks
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06024148 - Continuation of Anti-osteoporotic Treatment 1 Year After Initial Administration
Completed NCT03710889 - Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption Phase 3
Recruiting NCT05058976 - Romosozumab Use to Build Skeletal Integrity Phase 4
Completed NCT03798444 - Height Loss, Kyphosis Indicators, Bone Mineral Density and Vertebral Fractures in Chinese Postmenopausal Women
Completed NCT04960033 - Evaluating Fracture Risk Assessment Tools (FRAX) From Different Regions in Central South Chinese Postmenopausal Women
Completed NCT05366621 - Post-fracture Medication and Mortality
Not yet recruiting NCT04597931 - Evaluation of Romosozumab vs. Zoledronic Acid Effect in Patients With Spinal Cord Injury and Low Bone Mineral Density Phase 4
Completed NCT02483286 - Osteoporosis and Fall Prevention With Multiple Interventions in the Metropolitan Area N/A
Enrolling by invitation NCT03178799 - Randomized Fracture Liaison Services
Recruiting NCT03451305 - Postrual Reduction With Pillow in Osteoporotic Vertebral Fracture N/A
Recruiting NCT03811509 - Breast Cancer Women on Aromatase Inhibitors Treatment Phase 4
Recruiting NCT06379243 - Development and Validation of a Postoperative Re-fracture Risk Model for Osteoporotic Spinal Fractures N/A