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 6065% 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
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