Handball-based Exercise and Type 2 Diabetes

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Small-sided team handball training

• 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

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2021-06-03
• Study First Submitted QC: 2021-08-14
• Study First Posted: 2021-08-23
• Study Start: 2021-09-01
• Primary Completion: 2021-12-15
• Study Completion: 2021-12-20
• Last Update Submitted: 2022-03-03
• Last Update Posted: 2022-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Diagnosed with type 2 diabetes
• Understands and speaks danish

Exclusion Criteria

• If General Practitioner do not recommend participation in the intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Small-sided team handball training	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.

Primary Outcome Measures

Name	Time	Method
Peak oxygen uptake (VO2peak)	change from baseline to 12 weeks	Peak oxygen uptake measured with incremental cycling test
Concentration of Hemoglobin A1c (HbA1c) (mmol/mol)	change from baseline to 12 weeks	HbA1c measured with HemoCue HbA1c 501
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
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
Physical activity levels	change from baseline to 12 weeks	Physical activity scale (PAS)
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
Body mass index (BMI)	change from baseline to 12 weeks	Body mass index measured by kg/M2
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)

Trial Locations

Locations (1)

The Department of Physiotherapy, University College of Northern Denmark; 🇩🇰 Aalborg, Denmark