NCT01387334

Brief Summary

Resistance exercise is effective in improving glycemic control in diabetes patients. The effectiveness of a home-based resistance exercise program has not been establish.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_2 type-2-diabetes

Timeline
Completed

Started Feb 2007

Longer than P75 for phase_2 type-2-diabetes

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 4, 2011

Completed
Last Updated

July 4, 2011

Status Verified

June 1, 2011

Enrollment Period

2 years

First QC Date

June 13, 2011

Last Update Submit

June 30, 2011

Conditions

Type 2 Diabetes

Keywords

resistive exerciseResistance Exercise Training ProgramRubber BandsGlycemic ControlType 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    3 months

Secondary Outcomes (1)

  • compliance of home-based resistive exercise training

    3 years

Study Arms (1)

Resistance Exercise Training Program

EXPERIMENTAL
Behavioral: Resistance Exercise Training Program With Rubber Bands

Interventions

Resistance Exercise Training Program With Rubber BandsBEHAVIORAL

Resistive exercise consist of 5-min warm up, at least 30 min resistive exercise using rubber band as recommendation (8-12 times per set, at least 3 sets per day and at least 3 days per week) and 5-min cool down

Also known as: elastic band
Resistance Exercise Training Program

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes was diagnosed by physician using fasting plasma glucose not less than 126 mg/dl and/or HbA1c not less than 7 %.
  • Type 2 diabetes was diagnosed at least 6 months previously.
  • The subject was ongoing treatment in primary care unit of prince of Songkla University.

You may not qualify if:

  • Gestational diabetes and type 1 diabetes patients
  • History of cardiovascular disease within the pass 6 months or any unstable chronic condition including dementia, proliferative diabetic retinopathy, retinal hemorrhage or detachment, dialysis and diabetic foot patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Thanitha Sirirak, MD

    Department of Community Medicine, Faculty of Medicine, Prince of Songkla University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 13, 2011

First Posted

July 4, 2011

Study Start

February 1, 2007

Primary Completion

February 1, 2009

Study Completion

April 1, 2011

Last Updated

July 4, 2011

Record last verified: 2011-06

Locations

TH(1)