NCT02803190

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

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

June 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 16, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
6.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

December 19, 2023

Status Verified

November 1, 2022

Enrollment Period

11 months

First QC Date

June 3, 2016

Last Update Submit

December 18, 2023

Conditions

Osteoporosis Fracture

Keywords

Spine curvePostureFracturesarcopeniaExercise

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • appendicular skeletal muscle index

    baseline and 12 weeks

  • grip strength

    baseline and 12 weeks

  • walking speed

    baseline and 12 weeks

Study Arms (2)

ICG- integrated care group

EXPERIMENTAL

Integraded Care Group

Behavioral: ICG

MTG- muscle training group

EXPERIMENTAL

Muscle Traing Group

Behavioral: MTG

Interventions

ICGBEHAVIORAL

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.

ICG- integrated care group
MTGBEHAVIORAL

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.

MTG- muscle training group

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • older than 50 years of age
  • 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
  • having a bone mineral density test within one year period
  • having the capability to understand the study and complete the study interventions
  • willing to participate for the intervention and study follow ups

You may not qualify if:

  • People younger than 50 years of age
  • Could not communicate because of hearing, visual, or cognitive problems
  • Unable to stand and walk unaided (walking aids are acceptable)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

MeSH Terms

Conditions

Osteoporotic FracturesFractures, BoneSarcopeniaMotor Activity

Condition Hierarchy (Ancestors)

Wounds and InjuriesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsBehavior

Study Officials

  • Ding-Cheng Chan

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2016

First Posted

June 16, 2016

Study Start

June 1, 2016

Primary Completion

May 1, 2017

Study Completion

December 1, 2023

Last Updated

December 19, 2023

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)