Condition category
Nutritional, Metabolic, Endocrine
Date applied
11/03/2010
Date assigned
29/04/2010
Last edited
29/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Armando Raimundo

ORCID ID

Contact details

S/ Reguentos de Monsaraz
44
Pavilhão Gimnosdesportivo
University of Évora
Évora
7005-399
Portugal

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised controlled trial investigating the effects of 12 weeks of combined aerobic and resistance exercise program on serum profiles, functional capacity, isokinetic muscle strength and quality of life type 2 diabetes mellitus

Acronym

Study hypothesis

Type 2 diabetes is associated with obesity and physical inactivity and this impairment prevalence is increasing in occidental countries due to the growing predominance of obesity and sedentary life styles. The aim of this study is to analyse the adaptations induced by combined exercise on serum profiles, muscle strength and fatigue, physical fitness, corporal composition and quality of life related with health on type 2 diabetes mellitus patients.

Hypotheses:
1. The combined exercise therapy may lead to improvements in the neuromuscular function, physical fitness, metabolic parameters and health related-quality of life of type 2 diabetes patients.
2. Gains in neuromuscular function are related to improvements in metabolic parameters in patients with type 2 diabetes.
3. Gains in physical fitness are related to changes in health related-quality of life of type 2 diabetes patients.

Ethics approval

Ethics committee of health and well being of the University of Évora approved on the 10th of June of 2008 (ref: 08050)

Study design

Single centre interventional randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Type II diabetes mellitus

Intervention

The supervised exercise therapy consisted of 1 hour-session for 3-times/week and for 12-weeks. Each session included
1. 10 minutes of warming up with slow walks and easy movements of progressive intensity
2. 25 minutes of aerobic exercises at 60–65% of maximal heart rate
3. 15 minutes of strength exercises with lower and upper limb using patient's own weight resistance, light
loads (e.g. 2-4 sets of 10 repetitions of unilateral knee flexion-extension at a slow pace with the body in a vertical position or of raising the arms over the head holding a stick)
4. 10 minutes of overall mobility and cooling down.
Patients’ heart rate was monitored using a pulse-meter.
During this 3-month period, participants in the control group (CG) continued their daily activities, with no physical exercise similar to those in the therapy. There was no follow-up beyond the end of the 3 month intervention period.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The primary endpoint with respect to efficacy of the combined exercise therapy in type-2 diabetes patient was to produce a moderate decrease in serum glycated hemoglobine (HbA1c) levels. Therefore, this parameter was measured from fasting blood samples along others, such as fasting glucose, HDL and LDL cholesterol, triglycerides, alanino aminotransferase (ALT) and aspartate aminotrasnferase (AST) in a standardized manner at laboratories of the hospital of the city of Évora (Portugal).

Measurements were made at baseline and post-intervention at 12 weeks.

Secondary outcome measures

1. Muscle condition: maximal peak force of the knee extensors and flexors was recorded by using the Biodex System-3 Isokinetic Dynamometer (Biodex Corp., Shirley, NY, USA). Each subset performed biolateral tests of maximal isokinetic leg strength and leg muscle fatigue.
2. Health-related quality of life (HRQOL), measured using the Portuguese language version of the Short Form 36 Health Survey (SF-36)
3. Body composition: percentage fat, total and abdominal, were assessed using dual-energy X-ray absorptiometry (DXA, Norland Excell Plus, Norland Inc, Fort Atkinson, USA)
4. Functional capacity of the patients, assessed by several tests, performed in a standardized manner:
4.1. Maximal walking speed test over 10 metres
4.2. 10-stairs climbing test
4.3. 10-stairs climbing test carrying a bag weighing 5 kg in each hand
4.4. Timed up and go test
4.5. 30 seconds chair stand test
4.6. 6-minutes walking test
Measurements were made at baseline and post-intervention at 12 weeks.

Overall trial start date

10/09/2008

Overall trial end date

21/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Non-smokers and not consumers of alcohol
2. Either sex
3. Age between 30 and 70 years
4. At least 3 years with diagnosed type-2 diabetes mellitus

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50 potentially eligible, 43 gave consent (exercise group: 22; control group 21)

Participant exclusion criteria

Presence of any disorders that might prevent physical training load and require other psychological, physical or nutritional therapy

Recruitment start date

10/09/2008

Recruitment end date

21/12/2008

Locations

Countries of recruitment

Portugal

Trial participating centre

S/ Reguentos de Monsaraz, 44
Évora
7005-399
Portugal

Sponsor information

Organisation

University of Évora (Portugal)

Sponsor details

Reguengos de Monsaraz
44
Pavilhão Gimnodesportivo
University of Évora
Évora
7005-399
Portugal

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Évora (Portugal)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes