Handball-based Exercise and Type 2 Diabetes

NCT05015946 | Completed

• 1 other identifier: UCN-FoU-24000473
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Diabetes Mellitus; Glucose Metabolism Disorder; Metabolic Diseases; Endocrine System Disease; Team Handball Training; Team Sport

Outcome Measures

Primary Outcomes (3)

• Concentration of Hemoglobin A1c (HbA1c) (mmol/mol)

  HbA1c measured with HemoCue HbA1c 501

  change from baseline to 12 weeks

• Peak oxygen uptake (VO2peak)

  Peak oxygen uptake measured with incremental cycling test

  change from baseline to 12 weeks

• 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 Outcomes (10)

• Concentration of Cholesterol

  change from baseline to 12 weeks

• Body mass index (BMI)

  change from baseline to 12 weeks

• Body fat mass (kg)

  change from baseline to 12 weeks

• Lean body mass (kg)

  change from baseline to 12 weeks

• Visceral fat (hip/waist ratio)

  change from baseline to 12 weeks

Study Arms (1)

Small-sided team handball training

EXPERIMENTAL

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.

Behavioral: Small-sided team handball training

Interventions

Small-sided team handball training BEHAVIORAL

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.

Small-sided team handball training

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with type 2 diabetes
• Understands and speaks danish

You may not qualify if:

• If General Practitioner do not recommend participation in the intervention

Sponsors & Collaborators

• University College of Northern Denmark: lead
• Danish Handball Federation: collaborator
• The Danish Diabetes Association: collaborator
• Research Unit for General Practice in Aalborg: collaborator

Study Sites (1)

The Department of Physiotherapy, University College of Northern Denmark

Aalborg, 9210, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: August 23, 2021
• Study Start: September 1, 2021
• Primary Completion: December 15, 2021
• Study Completion: December 20, 2021
• Last Updated: March 4, 2022

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)