NCT01000519

Brief Summary

Randomized study on the comparison between aerobic training versus progressive resistance training over a 2 months period for older adults with type 2 diabetes. The hypothesis is that progressive resistance training is just as effective as aerobic training on Hba1c and could be an alternative training for those older diabetic patients who cannot participate in aerobic exercise.

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 not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Dec 2002

Longer than P75 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, 2002

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 23, 2009

Completed
Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

3.5 years

First QC Date

October 20, 2009

Last Update Submit

February 8, 2017

Conditions

Keywords

Diabetes mellitusRandomized control trialExerciseHemoglobin A, Glycosylated

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A, Glycosylated (Hba1c). Measuring unit: percentage

    Blood was drawn from each subject who fasted at least 10 hours overnight. Hba1c (%) was measured using high performance liquid chromatography (HPLC Variant II Bio Rad Laboratories, Munich, Germany). Change in Hba1c before and after intervention were looked at.

    2 months

Secondary Outcomes (3)

  • Peak volume of oxygen consumed (VO2peak) or fitness level. Measuring unit: ml/kg/min

    2 months

  • Anthropometric measurements

    2 months

  • Cholesterol

    2 months

Study Arms (2)

Aerobic Training

ACTIVE COMPARATOR

50 minutes of aerobic training, 18 sessions within 2 months period

Other: Aerobic Training

Progressive Resistance Training

EXPERIMENTAL

50 minutes of progressive resistance training consisting of nine resistance exercises, each conducted 3 sets of 10 repetitions. 18 sessions over 2 months period.

Other: Progressive resistance training

Interventions

18 sessions over 2 months period. Each session consist of 50 minutes of aerobic training at 65-70 % of maximum predicted heart rate

Also known as: Treadmill, Cross trainer, Cycling
Aerobic Training

18 sessions completed in 2 months. each session consists of 50 minutes of resistance training which is made up of 3 sets of 10 repetitions of nine resistive exercises using machines and free weights at 65-70% of 1-repetitive maximum.

Also known as: Weight training, Circuit training
Progressive Resistance Training

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 50 years and above,
  • Hba1c between 8 to 10 % in the past one month,
  • sedentary,
  • able to continuously walk for at least 20 minutes and climbed one flight of stairs unaided without stopping were eligible for participation.

You may not qualify if:

  • uncontrolled diabetes mellitus with Hba1c more than 10% or if escalation of treatment of glycemic control or dyslipidemia was likely to be necessary over the 2 months training period period,
  • congestive cardiac failure, unstable angina or acute myocardial infarction within the last one year,
  • proliferative diabetic retinopathy,
  • uncontrolled hypertension,
  • advanced arthritis likely to limit mobility or participation in prescribed exercises,
  • respiratory conditions such as asthma and chronic obstructive lung disease,
  • significant proteinuria or chronic renal insufficiency,
  • received drugs for the treatment of obesity or very low caloric diet (VLCD, less than 1000 kcal/ day),
  • renal disease and
  • inability to monitor glucose level or comply with exercise program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

Related Publications (4)

  • Boule NG, Haddad E, Kenny GP, Wells GA, Sigal RJ. Effects of exercise on glycemic control and body mass in type 2 diabetes mellitus: a meta-analysis of controlled clinical trials. JAMA. 2001 Sep 12;286(10):1218-27. doi: 10.1001/jama.286.10.1218.

    PMID: 11559268BACKGROUND
  • Arora E, Shenoy S, Sandhu JS. Effects of resistance training on metabolic profile of adults with type 2 diabetes. Indian J Med Res. 2009 May;129(5):515-9.

    PMID: 19675378BACKGROUND
  • Ng CL, Tai ES, Goh SY, Wee HL. Health status of older adults with Type 2 diabetes mellitus after aerobic or resistance training: a randomised trial. Health Qual Life Outcomes. 2011 Aug 2;9:59. doi: 10.1186/1477-7525-9-59.

  • Ng CL, Goh SY, Malhotra R, Ostbye T, Tai ES. Minimal difference between aerobic and progressive resistance exercise on metabolic profile and fitness in older adults with diabetes mellitus: a randomised trial. J Physiother. 2010;56(3):163-70. doi: 10.1016/s1836-9553(10)70021-7.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusMotor Activity

Interventions

Exercise TestResistance TrainingCircuit-Based Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative TechniquesExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Li Whye Cindy Ng

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 20, 2009

First Posted

October 23, 2009

Study Start

December 1, 2002

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

February 10, 2017

Record last verified: 2017-02

Locations