Primary Objective: (1) To study the efficacy of low volume high-intensity resistance training for improving glycemic control in patients with T2DM. Secondary Objectives: (2) To study the feasibility of low volume high-intensity resistance training…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
(1) glycemic control
The absolute change in plasma glycosylated haemoglobin concentration (HbA1c
[%]) from baseline to the end of the intervention period between both groups
will be assessed as main outcome for glycemic control. In addition fasting
plasma glucose (mmol/L) will be assessed.
Secondary outcome
(2) Feasibility
Feasibility will be assessed on the basis of retention, adherence and adverse
events. For retention the attrition rate will be established, defined as
discontinuation of the intervention or loss to follow-up following
randomization or by the end of the intervention period. Adherence will be
measured through attendance to the exercise sessions and compliance to the
prescribed intensities. All exercise sessions will be monitored by study
personnel who note attendance in a log and ensure each participant completes
each exercise bout at the individually prescribed intensity and duration.
(3) Risk factors for cardiovascular disease
i. Blood pressure
Both systolic and diastolic blood pressure (mmHg) will be measured.
ii. Plasma lipid values
The total cholesterol, HDL cholesterol and LDL cholesterol levels
(mmol/L) will be assessed.
iii. Body composition
Body weight (kg) and height (m) will be assessed and will be used to
establish the Body Mass Index (BMI [kg/mm2]). In addition, the waist
circumference (cm) will be measured.
(4) Muscle strength
Strength testing involves determination of the maximum weight (kg) that can be
lifted 1 time while maintaining proper form (1RM). Testing will be done for 2
exercises that are included in the training program (chest press and leg
press). In addition, the maximal voluntary torque (MVT) of the knee extensor
muscles will be determined isometrically on a custom-made dynamometer (Faculty
of Human Movement Sciences, VU University Amsterdam, Netherlands).
(5) Physical functioning
For physical functioning endurance, walking speed and balance will be assessed.
Endurance testing involves determination of the distance walked (m) during the
Six-Minute Walk Test (6MWT). Walking speed and balance will be assessed with
the 10 meter walk test (10MWT) and the Balance Test, both of which are included
in the Short Physical Performance Battery (SPPB), a short performance battery
assessing lower extremity function.
(6) Medication use
The patient*s medical files will be used to assess changes in medication use
during the study period.
(7) Well-being
For well-being the quality of life (QoL) and self-management will be assessed.
QoL will be measured with the Medical Outcome Study 36-Item Short-Form Health
Survey' (SF-36). Self-management will be measured with the 'Dutch version of
the Self Sufficiency Maxtrix (SSM-D)'.
Background summary
The prevalence of type 2 diabetes mellitus (T2DM) is rapidly increasing
world-wide and, for example, in The Netherlands over 750.000 registered cases
were diagnosed with T2DM in 2011. Despite an overwhelming body of evidence
demonstrating the efficacy of regular physical activity to treat or prevent
T2DM, there is no consensus on the nature of exercise therapy required to
provide adequate health benefits. Aerobic exercise has traditionally been
advocated. Recent position statements from the American Diabetes Association
(ADA) and the American College of Sports Medicine (ACSM) also recommend the use
of resistance training as part of a well-rounded exercise program.
The guidelines for resistance training have largely been based on
information regarding healthy individuals and the few randomized controlled
trials of resistance training in individuals with T2DM completed at the time
that they were published. In line with the aerobic exercise prescriptions, the
focus is on high volume and moderate-intensity exercise, which, especially
sedentary older patients with T2DM may find difficult to sustain. Moreover, it
appears that that the impact of progressive resistance training on muscle mass
and muscle strength in both young and older individuals is more pronounced if
higher training intensities are used. In older adults without diabetes,
high-intensity progressive resistance training programs have been reported to
have significant effects on daily energy expenditure, body composition, and
insulin sensitivity. To our knowledge, no study has examined the long-term
effects and feasibility of low volume high-intensity progressive resistance
training in individuals with T2DM. The absence of such data has precluded
specific recommendations by the ACSM and ADA with respect to the merits of low
volume high-intensity resistance training for individuals with T2DM.
Study objective
Primary Objective:
(1) To study the efficacy of low volume high-intensity resistance training for
improving glycemic control in patients with T2DM.
Secondary Objectives:
(2) To study the feasibility of low volume high-intensity resistance training
for improving glycemic control in patients with T2DM.
(3) To study the effect of low volume high-intensity resistance training on
risk factors for cardiovascular disease, muscle strength, physical functioning,
medication use and well-being in patients with T2DM.
Study design
A 26-week, single-centre, randomized controlled trial.
Intervention
Patients will be randomized to one of two groups, i.e. (1) low volume
high-intensity resistance training + usual care, (2) usual care. The
intervention consists of 20-30 minute training sessions once per week over a
period of 26 weeks.
Study burden and risks
The blood samples for determination of glycemic control will be collected by
the patient*s general practitioner (or by the SHL-groep) as part of the
standard medical treatment. Additionally, 5ml/a time extra blood will be
collected from the same line (required for determination of the plasma lipid
values, and during the first visit (intake) for determination of the serum
creatinine level). Each visit will take approximately 15 minutes.
All patients will be asked to visit the main office of TWB before and
after the intervention period to participate in a physical examination and to
fill out questionnaires. The duration of the physical examination, during which
measures of blood pressure, body composition, muscle strength (1-RM and MVT),
and physical functioning (6MWT, 10MWT and the Balance Test) are determined,
will be approximately 1.5 hour. Following the physical examination, all
patients receive two questionnaires (SF-36 and SSM-D) to fill out. The duration
for completing the questionnaires is approximately half an hour so that the
complete procedure has a duration of approximately 2 hours per visit.
Possible medical risks related to the physical fitness tests are considered
minimal. To check for contra-indications for high-intensity exercise, a
physician will thoroughly examine all patients before participation according
to the guidelines by the ACSM and ADA. TWB is well experienced in providing the
training program, and therefore, the occurrence of medical events is considered
minimal.
Considering the positive effects of high-intensity resistance training
known from preliminary research it can be concluded that the benefits outweigh
the burden and minimal risk associated with this study.
Belder 2-4
Roosendaal 4704 RK
NL
Belder 2-4
Roosendaal 4704 RK
NL
Listed location countries
Age
Inclusion criteria
(1) Diagnosis of T2DM by the American Diabetes Association criteria, i.e. a) HbA1c >=6.5%, or b) fasting plasma glucose >=7.0 mmol/L, or c) 2-h plasma glucose >=11.1 mmol/L.
(2) Baseline HbA1c value of 6.6% to 9.9% (normal range, 4.0% to 6.0%).
(3) Minimum age of 18 years.
Exclusion criteria
(1) Current insulin therapy.
(2) Participation in exercise 2 or more times weekly for 20 minutes or longer per session or in any resistance training during the previous 6 months.
(3) Insufficient mastery of the Dutch language.
(4) Cognitive impairment
(5) Changes during the previous 2 months in oral hypoglycemic, antihypertensive,or lipid-lowering agents or body weight (>=5%).
(6) Serum creatinine level of 200 µmol/L or greater (>=2.26 mg/dL).
(7) Proteinuria greater than 1 g/d.
(8) Blood pressure greater than 160/100 mm Hg.
(9) Restrictions in physical activity because of disease.
(10) Presence of other medical conditions that made participation inadvisable.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL47925.028.15 |