Handball-based Exercise and Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05015946
• Other study ID #: UCN-FoU-24000473
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 20, 2021

Study information

• Verified date: September 2020
• Source: University College of Northern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• Small-sided team handball training
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.

Locations

Country	Name	City	State
Denmark	The Department of Physiotherapy, University College of Northern Denmark	Aalborg

Sponsors (4)

Lead Sponsor	Collaborator
University College of Northern Denmark	Danish Handball Federation, Research Unit of General Practice, Aalborg, The Danish Diabetes Association

Country where clinical trial is conducted

Denmark, 

Outcome

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.