The aim of this study is to determine whether a physical reactivation program is more effective in improving physical activity, quality of life, diabetes control and psychosocial well being than usual care.
ID
Source
Brief title
Condition
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the level of physical activity, assessed with the Short
Questionnaire to Assess Health enhancing physical activity (SQUASH).
Secondary outcome
The secondary outcomes are *quality of life*, determined by means of the World
Health Organisation Quality Of Life brief questionnaire (WHOQOL-BREF) and
*diabetes control*, which is determined by means of several biological factors
(such as HbA1c and blood pressure). To determine exercise behaviour
determinants, several psychosocial factors (such as depression and
self-efficacy) are assessed by means of validated questionnaires.
Background summary
Type-2 diabetes mellitus is a highly prevalent disease, which is associated
with major complications. In order to regulate diabetes accurately, complex
care is essential. In diabetes care the adaptation to a healthy lifestyle is an
important factor, with a predominant role for physical activity. Despite
ongoing diabetes exercise programs, the prevalence of inactivity among
diabetics remains high. In order to improve physical activity in diabetic
patients a physical reactivation program is implemented in diabetes care, which
will be evaluated in this study.
Study objective
The aim of this study is to determine whether a physical reactivation program
is more effective in improving physical activity, quality of life, diabetes
control and psychosocial well being than usual care.
Study design
By means of a randomisation procedure, performed at the level of general
practitioners practice, patients are allocated to the intervention or control
group.
Patients allocated to the intervention group will receive regular diabetes care
and participate in the physical reactivation program.
Patients allocated to the control group will receive regular diabetes care.
Intervention
The intervention consists of a 12-week music-accompanied physical reactivation
program, which is designed to improve the participants* exercise level and
self-efficacy. Within this 12-week physical reactivation program the patient is
prepared for exercise activities after the 12-week intervention period and is
exercise continuation promoted. After the exercise program, two exercise boosts
are offered (at 6 and 12 months from baseline), which will be preceded by a
telephone call as a reminder of the questionnaire and the upcoming exercise
session and to encourage the patient to come to the exercise session.
Study burden and risks
All patients included in this study will receive regular diabetes care. During
the one-year follow up patients assigned to the intervention group will
additionally participate in a 12-week exercise program and will be stimulated
to continue performing exercise. Besides this, all included patients -including
the patients allocated to control group- will be asked to fill in the
questionnaire 4 times, which will take 25 minutes each time. No additional
invasive measurements are necessary, as these assessments are part of regular
diabetes care.
Postbus 93245
2509 AE Den Haag
NL
Postbus 93245
2509 AE Den Haag
NL
Listed location countries
Age
Inclusion criteria
The patient is a type-2 diabetic patient
The patient has a Caucasian ethnicity
The patient is diagnosed with diabetes at least one year ago
The patient*s BMI is over 25 kg/m2 and maximal 40 kg/ m2
The patient is born between 1931 and 1956
Exclusion criteria
The patient performs exercise more than 2 hours a week
The patient is limited in walking 100 meter
The patient suffers from severe malignant hypertension
The patient suffers from unknown, untreated cardiac ischemia
The patient has physical or cognitive limitations in performing physical exercise
The patient suffers from a life-threatening comorbidity (such as cancer)
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 | NL19574.015.07 |