Handball-based Exercise and Type 2 Diabetes

Study Overview
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Brief Summary
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This single-arm pilot study aims to investigate the feasibility of a handball-based intervention to people diagnosed with type 2 diabetes, including monitoring aerobic intensities and movement strategies during the intervention, and monitoring recruitment, adherence, and adverse events. Furthermore, the study aims to investigate the feasibility of a test battery including both physiological and patient-reported outcomes, and to investigate preliminary exercise effects.

Detailed Description
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Physical activity and exercise are known to be beneficial for increasing insulin sensitivity in skeletal muscle in healthy as well as in individuals with type 2 diabetes. But many patients who recently have been diagnosed with type-2 diabetes is often living a sedentary lifestyle and have poor adherence to physical interventions. High intensity interval training as well as team-based interventions has proven to be effectful in regulation of physiological parameters related to type 2 diabetes. The aim of this study is to investigate the feasibility of a handball-based intervention to people diagnosed with type 2 diabetes

Official Title
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Handball-based Exercise for People Diagnosed With Type 2 Diabetes: a Feasibility Study

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Small-sided team handball training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with type 2 diabetes Understands and speaks danish Exclusion Criteria: If General Practitioner do not recommend participation in the intervention

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Small-sided team handball training<br>60 minutes small-sided team handball training. Initial 20 minutes of warm-up including exercises for strength, aerobic, balance, coordination, and mobility. Hereafter 20 minutes of handball specific exercises including dribbling, running and shooting. Final 20 minutes of small-sided handball matches. | Behavioral: Small-sided team handball training<br>* 60 minutes small-sided team handball training. Initial 20 minutes of warm-up including exercises for strength, aerobic, balance, coordination, and mobility. Hereafter 20 minutes of handball specific exercises including dribbling, running and shooting. Final 20 minutes of small-sided handball matches.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of Hemoglobin A1c (HbA1c) (mmol/mol) | HbA1c measured with HemoCue HbA1c 501 | change from baseline to 12 weeks | 
| Peak oxygen uptake (VO2peak) | Peak oxygen uptake measured with incremental cycling test | change from baseline to 12 weeks | 
| Health related quality of life (HRQoL) | Health related quality of life measured with the danish version of Short Form 36 (SF-36) | change from baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of Cholesterol | Total cholesterol, low density lipoprotein (LDL), high density lipoprotein (HDL) measured with Accutrend Plus Cholesterol Meter | change from baseline to 12 weeks | 
| Body mass index (BMI) | Body mass index measured by kg/M2 | change from baseline to 12 weeks | 
| Body fat mass (kg) | Total body fat in kg measured with Tanita MC-180MA, Tokyo, Japan | change from baseline to 12 weeks | 
| Lean body mass (kg) | Lean body mass in kg measured with Tanita MC-180MA, Tokyo, Japan | change from baseline to 12 weeks | 
| Visceral fat (hip/waist ratio) | Visceral adipose tissue measured with hip (widest part of the hip) and waist (2.5 cm above the navel) ratio. | change from baseline to 12 weeks | 
| Blood pressure and resting puls | Blood pressure and resting puls measured with an automatic upperarm blood pressure monitor | change from baseline to 12 weeks | 
| Aerobic performance test (aerobic endurance) | Aerobic endurance measured with Intermittent Recovery Test Level 1 | change from baseline to 12 weeks | 
| Self-care behavior | Self-care behavior measured with diabetes Intention, Attitude, and Behavior Questionnaire (DIAB-Q) | change from baseline to 12 weeks | 
| Physical activity levels | Physical activity scale (PAS) | change from baseline to 12 weeks | 
| Aerobic intensity and movement patterns | Aerobic intensities (percent of maximal heart rate) measured with pulse monitor, and movement patterns (Metabolic Equivalent of Task (MET)) measured with accelerometer. | measured during intervention in week 2,3,6,7,10 and 11. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Glucose Metabolism Disorder, Metabolic Diseases, Endocrine System Disease, Team Handball Training, Team Sport