Clinical trial NCT05015946: Handball-based Exercise and Type 2 Diabetes
Official title: Handball-based Exercise for People Diagnosed With Type 2 Diabetes: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Diabetes Mellitus
Glucose Metabolism Disorder
Metabolic Diseases
Endocrine System Disease
Team Handball Training
Team Sport
Lead sponsor: University College of Northern Denmark
Sponsor class: OTHER
Collaborators: name: Danish Handball Federation
name: The Danish Diabetes Association
name: Research Unit for General Practice in Aalborg
First posted: 2021-08-23
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

* Diagnosed with type 2 diabetes
* Understands and speaks danish

Exclusion Criteria:

* If General Practitioner do not recommend participation in the intervention

Primary outcomes:
measure: Concentration of Hemoglobin A1c (HbA1c) (mmol/mol)
timeFrame: change from baseline to 12 weeks
measure: Peak oxygen uptake (VO2peak)
timeFrame: change from baseline to 12 weeks
measure: Health related quality of life (HRQoL)
timeFrame: change from baseline to 12 weeks
Secondary outcomes:
measure: Concentration of Cholesterol
timeFrame: change from baseline to 12 weeks
measure: Body mass index (BMI)
timeFrame: change from baseline to 12 weeks
measure: Body fat mass (kg)
timeFrame: change from baseline to 12 weeks
measure: Lean body mass (kg)
timeFrame: change from baseline to 12 weeks
measure: Visceral fat (hip/waist ratio)
timeFrame: change from baseline to 12 weeks
measure: Blood pressure and resting puls
timeFrame: change from baseline to 12 weeks
measure: Aerobic performance test (aerobic endurance)
timeFrame: change from baseline to 12 weeks
measure: Self-care behavior
timeFrame: change from baseline to 12 weeks
measure: Physical activity levels
timeFrame: change from baseline to 12 weeks
measure: Aerobic intensity and movement patterns
timeFrame: measured during intervention in week 2,3,6,7,10 and 11.
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: The Department of Physiotherapy, University College of Northern Denmark
Study officials:
References: