Type 2 Diabetes Clinical Trial
Official title:
Handball-based Exercise for People Diagnosed With Type 2 Diabetes: a Feasibility Study
Verified date | September 2020 |
Source | University College of Northern Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | December 20, 2021 |
Est. primary completion date | December 15, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years and older |
Eligibility | Inclusion Criteria: - Diagnosed with type 2 diabetes - Understands and speaks danish Exclusion Criteria: - If General Practitioner do not recommend participation in the intervention |
Country | Name | City | State |
---|---|---|---|
Denmark | The Department of Physiotherapy, University College of Northern Denmark | Aalborg |
Lead Sponsor | Collaborator |
---|---|
University College of Northern Denmark | Danish Handball Federation, Research Unit of General Practice, Aalborg, The Danish Diabetes Association |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Concentration of Hemoglobin A1c (HbA1c) (mmol/mol) | HbA1c measured with HemoCue HbA1c 501 | change from baseline to 12 weeks | |
Primary | Peak oxygen uptake (VO2peak) | Peak oxygen uptake measured with incremental cycling test | change from baseline to 12 weeks | |
Primary | 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 | 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 | |
Secondary | Body mass index (BMI) | Body mass index measured by kg/M2 | change from baseline to 12 weeks | |
Secondary | Body fat mass (kg) | Total body fat in kg measured with Tanita MC-180MA, Tokyo, Japan | change from baseline to 12 weeks | |
Secondary | Lean body mass (kg) | Lean body mass in kg measured with Tanita MC-180MA, Tokyo, Japan | change from baseline to 12 weeks | |
Secondary | 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 | |
Secondary | Blood pressure and resting puls | Blood pressure and resting puls measured with an automatic upperarm blood pressure monitor | change from baseline to 12 weeks | |
Secondary | Aerobic performance test (aerobic endurance) | Aerobic endurance measured with Intermittent Recovery Test Level 1 | change from baseline to 12 weeks | |
Secondary | Self-care behavior | Self-care behavior measured with diabetes Intention, Attitude, and Behavior Questionnaire (DIAB-Q) | change from baseline to 12 weeks | |
Secondary | Physical activity levels | Physical activity scale (PAS) | change from baseline to 12 weeks | |
Secondary | 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. |
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