NCT01638351

Brief Summary

The purpose of this study is to investigate the effect of a 12-week progressive resistance training program on the skeletal muscle function, glycemic control, functional capacity, and quality of life in the elderly with type 2 diabetes mellitus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Dec 2011

Shorter than P25 for not_applicable diabetes-mellitus-type-2

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

December 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

November 16, 2012

Status Verified

November 1, 2012

Enrollment Period

10 months

First QC Date

July 8, 2012

Last Update Submit

November 15, 2012

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes mellitusResistance exerciseElderlySkeletal muscle dysfunctionMetabolomics

Outcome Measures

Primary Outcomes (1)

  • Maximal muscle strength

    This outcome measure includes upper and lower body maximal muscle strength.

    Twelve weeks

Secondary Outcomes (7)

  • Physical body function

    Twelve weeks

  • Quality of life

    Twelve weeks

  • Waist circumference

    Twelve weeks

  • Body mass index

    Twelve weeks

  • Functional capacity

    Twelve weeks

  • +2 more secondary outcomes

Study Arms (2)

Usual care

ACTIVE COMPARATOR

Participants in this arm will receive a brochure specific for type 2 diabetes mellitus about the general principles of exercise, nutrition, and diet. They are asked to maintain their activity level.

Behavioral: Usual care

Resistance exercise

EXPERIMENTAL

Progressive resistance training, 3 times a week for 12 weeks

Behavioral: Resistance exercise

Interventions

Resistance exerciseBEHAVIORAL

Progressive resistance exercise training, 3 times a week for 12 weeks.

Resistance exercise
Usual careBEHAVIORAL

Participants in this arm will receive a brochure specific for type 2 diabetes mellitus about the general principles of exercise, nutrition, and diet. They are asked to maintain their activity level.

Usual care

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • years old or older
  • no clinical diagnosis of cardiovascular disease
  • patients with or without type 2 diabetes mellitus

You may not qualify if:

  • glycated hemoglobin \> 10%
  • pulmonary disease
  • cancer
  • cognitive dysfunction
  • any neurological or musculoskeletal disease that will affect exercise performance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (4)

  • Castaneda C, Layne JE, Munoz-Orians L, Gordon PL, Walsmith J, Foldvari M, Roubenoff R, Tucker KL, Nelson ME. A randomized controlled trial of resistance exercise training to improve glycemic control in older adults with type 2 diabetes. Diabetes Care. 2002 Dec;25(12):2335-41. doi: 10.2337/diacare.25.12.2335.

    PMID: 12453982BACKGROUND

  • Dunstan DW, Daly RM, Owen N, Jolley D, De Courten M, Shaw J, Zimmet P. High-intensity resistance training improves glycemic control in older patients with type 2 diabetes. Diabetes Care. 2002 Oct;25(10):1729-36. doi: 10.2337/diacare.25.10.1729.

    PMID: 12351469BACKGROUND

  • Brandon LJ, Gaasch DA, Boyette LW, Lloyd AM. Effects of long-term resistive training on mobility and strength in older adults with diabetes. J Gerontol A Biol Sci Med Sci. 2003 Aug;58(8):740-5. doi: 10.1093/gerona/58.8.m740.

    PMID: 12902533BACKGROUND

  • Cheung NW, Cinnadaio N, Russo M, Marek S. A pilot randomised controlled trial of resistance exercise bands in the management of sedentary subjects with type 2 diabetes. Diabetes Res Clin Pract. 2009 Mar;83(3):e68-71. doi: 10.1016/j.diabres.2008.12.009. Epub 2009 Jan 20.

    PMID: 19157617BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ying-Tai Wu, Ph.D.

    School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University (R.O.C.)

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

July 8, 2012

First Posted

July 11, 2012

Study Start

December 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

November 16, 2012

Record last verified: 2012-11

Locations

TW(1)