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The impact of a physical reactivation program on type-2 diabetes patients.


- candidate number2990
- NTR NumberNTR1175
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-jan-2008
- Secondary IDs19574 CCMO (ABR-nummer)
- Public TitleThe impact of a physical reactivation program on type-2 diabetes patients.
- Scientific TitleThe effect of implementation of a physical reactivation program on physical activity behaviour, quality of life and biological and psychosocial factors on type-2 diabetes patients.
- ACRONYMThe impact of a physical reactivation program on type-2 diabetes patients
- hypothesisA physical reactivation program is more effective in improving physical activity behaviour, quality of life, diabetic parameters and psychosocial well being than usual care in type-2 diabetic patients.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II)
- Inclusion criteria1. The patient is a type-2 diabetes patient;
2. The patient has a Caucasian ethnicity;
3. The patient is diagnosed with diabetes at least one year ago;
4. The patient’s BMI is over 25 kg/m2 and maximal 40 kg/m2;
5. The patient is born between 1931 and 1956.
- Exclusion criteria1. The patient performs exercise more than 2 hours a week;
2. The patient is limited in walking 100 meter;
3. The patient suffers from severe malignant hypertension;
4. The patient suffers from unknown, untreated cardiac ischemia;
5. The patient has physical or cognitive limitations in performing physical exercise;
6. The patient suffers from a life-threatening comorbidity (such as cancer).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2008
- planned closingdate1-mei-2009
- Target number of participants204
- InterventionsThe 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.
- Primary outcomeThe primary outcome is the level of physical activity, assessed with the Short Questionnaire to Assess Health enhancing physical activity (SQUASH).
- Secondary outcomeThe 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.
- TimepointsThe control group, as well as the intervention group, will be monitored for one year. At baseline, questionnaires will be assessed. This assessment will be repeated three months after inclusion, at the end of the music-accompanied exercise program. Subsequently, the questionnaires are carried out six months and twelve months after inclusion. Data concerning biological parameters will be collected at baseline and twelve months after baseline measurement.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES E.S.J. Rooij van
- CONTACT for SCIENTIFIC QUERIESMD, PhD, Professor of Primary Care V.J.M. Pop
- Sponsor/Initiator POZOB
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryRationale:
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.


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 general practice level, 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.


Study population:
The study population will consist of 204 Caucasian, inactive, overweight diabetic patients born between 1931 and 1956. Patients are excluded from participation if they can walk less them 100 meters, suffer from severe malignant hypertension, untreated cardiac ischemia or a life-threatening co-morbidity, if the patient experiences physical or cognitive limitations in performing exercise.


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.


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. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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.
- Main changes (audit trail)
- RECORD8-jan-2008 - 9-apr-2008


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