NCT02001376

Brief Summary

Background and Purpose: Fitness is the foundation for health and quality of life for individuals. Recent changes in lifestyle and eating habit in Taiwan have significantly increased the prevalence of metabolic syndrome that may lead to poor fitness and subsequent coronary artery disease, cardiovascular disease and diabetes. Although workers at the National Taiwan University Hospital (NTUH) have undertaken regular health fitness examination, the examination did not include the posture and movement analysis and no exercise intervention was provided to those with metabolic syndrome. This study is therefore aimed to conduct comprehensive health fitness examination for workers at NTUH and to examine whether exercise intervention could decrease the risk factors and enhance fitness in those at risk or with metabolic syndrome. Methods: This study will consist of two parts. In the first part, 1102 workers at NTUH will be administered comprehensive fitness examination (body mass index, waist circumference, muscle strength, flexibility, balance, cardiopulmonary test, and posture and movement analysis) and will be assessed with the Physical Activity Readiness and the Perceived Musculoskeletal Pain Scale and the International Physical Activity Questionnaire. Those workers who are at risk or have metabolic syndrome (N=240) will be assigned into the control, home-based exercise, and intensive exercise group with 80 in each group with their will. The home-based exercise group will receive exercise instruction biweekly for three months; the intensive exercise group will receive moderate aerobic exercise and strengthening exercise three times a week for three months. The other workers who are insufficient fitness status (N=240) will be assigned into the control, home-based exercise, and intensive exercise group with their will. The home-based exercise group will receive exercise instruction biweekly for a month; the intensive exercise group with 80 in each group will receive moderate aerobic exercise and strengthening exercise three times a week for a month. Descriptive statistics will be used to estimate the prevalence of 1, 2 and ≧3 metabolic risk factors, and poor fitness. One-way analysis of variance (ANOVA) will be used to examine the relation between metabolic syndrome risk factors and fitness. One-way ANOVA will be used to compare the demographic characteristics of the control, home-based exercise, and intensive exercise group. Two-way ANOVA repeated measures will be used to examine the metabolic syndrome risk factors and fitness in the three groups across time. Clinical relevance: Our results will help understand the health fitness of workers at NTUH and will assist in establishing effective exercise program for those at risk or with metabolic syndrome.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 4, 2013

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

November 4, 2019

Status Verified

August 1, 2019

Enrollment Period

9.3 years

First QC Date

September 25, 2013

Last Update Submit

October 31, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • All improve fitness status

    Body mass index, BMI is calculated by dividing a person's weight (in kilograms) by his or her height (in meters, squared).

    36 weeks

Secondary Outcomes (1)

  • All improve fitness status

    36 weeks

Other Outcomes (5)

  • All improve fitness status

    36 weeks

  • All improve fitness status

    36 weeks

  • All improve fitness status

    36 weeks

  • +2 more other outcomes

Study Arms (3)

Intensive exercise & home exercise

EXPERIMENTAL

Intensive exercise group Home exercise group

Other: Intensive exerciseOther: Home exercise

Intensive exercise & control

EXPERIMENTAL

Intensive exercise group Control group

Other: Intensive exerciseOther: Control group live as usual

Home exercise & control group

EXPERIMENTAL

Home exercise Control group

Other: Home exerciseOther: Control group live as usual

Interventions

The intensive exercise group will receive moderate aerobic exercise and strengthening exercise three times a week for three months.

Intensive exercise & controlIntensive exercise & home exercise

The home-based exercise group will receive exercise instruction biweekly for three months

Home exercise & control groupIntensive exercise & home exercise

Control group means no any intervention for them. The control group who with metabolic syndrome risk factors just live as usual.

Also known as: Control group
Home exercise & control groupIntensive exercise & control

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 20-60 years old
  • At least one metabolic syndrome risk factor (Elevated blood pressure: Equal to or greater than 120/80 mm Hg, Central obesity: waist circumference ≥ 90 cm (male), ≥ 80 cm (female), Elevated triglycerides: Equal to or greater than 150 mg/dL, Reduced HDL cholesterol: Men - Less than 40 mg/dL Women - Less than 50 mg/dL, Elevated fasting glucose: Equal to or greater than 100 mg/dL)

You may not qualify if:

  • diastolic blood pressure greater than 139 mm Hg or systolic blood pressure greater than 89 mm Hg
  • fasting glucose greater than 125 mg/dL
  • triglycerides greater than 199 mg/dL
  • Subjects have in progress cardiovascular disease or in treatment course
  • chest distress, short of breath, dizziness, faint in recent 3 months
  • Muscular skeletal system injury or pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical Therapy Center, National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Abdominal obesity metabolic syndrome

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Jau-Yih Tsauo, PhD

    National Taiwan University Hospital

    STUDY CHAIR

Central Study Contacts

Jau-Yih Tsauo, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2013

First Posted

December 4, 2013

Study Start

April 1, 2011

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

November 4, 2019

Record last verified: 2019-08

Locations