Handball-based Exercise and Type 2 Diabetes
- Conditions
- Type 2 Diabetes
- Registration Number
- NCT05015946
- Lead Sponsor
- University College of Northern Denmark
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- Diagnosed with type 2 diabetes
- Understands and speaks danish
- If General Practitioner do not recommend participation in the intervention
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Concentration of Hemoglobin A1c (HbA1c) (mmol/mol) change from baseline to 12 weeks HbA1c measured with HemoCue HbA1c 501
Peak oxygen uptake (VO2peak) change from baseline to 12 weeks Peak oxygen uptake measured with incremental cycling test
Health related quality of life (HRQoL) change from baseline to 12 weeks Health related quality of life measured with the danish version of Short Form 36 (SF-36)
- Secondary Outcome Measures
Name Time Method Physical activity levels change from baseline to 12 weeks Physical activity scale (PAS)
Body fat mass (kg) change from baseline to 12 weeks Total body fat in kg measured with Tanita MC-180MA, Tokyo, Japan
Lean body mass (kg) change from baseline to 12 weeks Lean body mass in kg measured with Tanita MC-180MA, Tokyo, Japan
Blood pressure and resting puls change from baseline to 12 weeks Blood pressure and resting puls measured with an automatic upperarm blood pressure monitor
Aerobic intensity and movement patterns measured during intervention in week 2,3,6,7,10 and 11. Aerobic intensities (percent of maximal heart rate) measured with pulse monitor, and movement patterns (Metabolic Equivalent of Task (MET)) measured with accelerometer.
Concentration of Cholesterol change from baseline to 12 weeks Total cholesterol, low density lipoprotein (LDL), high density lipoprotein (HDL) measured with Accutrend Plus Cholesterol Meter
Visceral fat (hip/waist ratio) change from baseline to 12 weeks Visceral adipose tissue measured with hip (widest part of the hip) and waist (2.5 cm above the navel) ratio.
Aerobic performance test (aerobic endurance) change from baseline to 12 weeks Aerobic endurance measured with Intermittent Recovery Test Level 1
Self-care behavior change from baseline to 12 weeks Self-care behavior measured with diabetes Intention, Attitude, and Behavior Questionnaire (DIAB-Q)
Body mass index (BMI) change from baseline to 12 weeks Body mass index measured by kg/M2
Trial Locations
- Locations (1)
The Department of Physiotherapy, University College of Northern Denmark
🇩🇰Aalborg, Denmark
The Department of Physiotherapy, University College of Northern Denmark🇩🇰Aalborg, Denmark