Handball-based Exercise and Type 2 Diabetes

March 3, 2022 updated by: University College of Northern Denmark

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9210
        • The Department of Physiotherapy, University College of Northern Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with type 2 diabetes
  • Understands and speaks danish

Exclusion Criteria:

  • If General Practitioner do not recommend participation in the intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of Hemoglobin A1c (HbA1c) (mmol/mol)
Time Frame: change from baseline to 12 weeks
HbA1c measured with HemoCue HbA1c 501
change from baseline to 12 weeks
Peak oxygen uptake (VO2peak)
Time Frame: change from baseline to 12 weeks
Peak oxygen uptake measured with incremental cycling test
change from baseline to 12 weeks
Health related quality of life (HRQoL)
Time Frame: change from baseline to 12 weeks
Health related quality of life measured with the danish version of Short Form 36 (SF-36)
change from baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of Cholesterol
Time Frame: change from baseline to 12 weeks
Total cholesterol, low density lipoprotein (LDL), high density lipoprotein (HDL) measured with Accutrend Plus Cholesterol Meter
change from baseline to 12 weeks
Body mass index (BMI)
Time Frame: change from baseline to 12 weeks
Body mass index measured by kg/M2
change from baseline to 12 weeks
Body fat mass (kg)
Time Frame: change from baseline to 12 weeks
Total body fat in kg measured with Tanita MC-180MA, Tokyo, Japan
change from baseline to 12 weeks
Lean body mass (kg)
Time Frame: change from baseline to 12 weeks
Lean body mass in kg measured with Tanita MC-180MA, Tokyo, Japan
change from baseline to 12 weeks
Visceral fat (hip/waist ratio)
Time Frame: 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.
change from baseline to 12 weeks
Blood pressure and resting puls
Time Frame: change from baseline to 12 weeks
Blood pressure and resting puls measured with an automatic upperarm blood pressure monitor
change from baseline to 12 weeks
Aerobic performance test (aerobic endurance)
Time Frame: change from baseline to 12 weeks
Aerobic endurance measured with Intermittent Recovery Test Level 1
change from baseline to 12 weeks
Self-care behavior
Time Frame: change from baseline to 12 weeks
Self-care behavior measured with diabetes Intention, Attitude, and Behavior Questionnaire (DIAB-Q)
change from baseline to 12 weeks
Physical activity levels
Time Frame: change from baseline to 12 weeks
Physical activity scale (PAS)
change from baseline to 12 weeks
Aerobic intensity and movement patterns
Time Frame: 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.
measured during intervention in week 2,3,6,7,10 and 11.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College of Northern Denmark

Collaborators

The Danish Diabetes Association
Research Unit of General Practice, Aalborg
Danish Handball Federation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

December 15, 2021

Study Completion (Actual)

December 20, 2021

Study Registration Dates

First Submitted

June 3, 2021

First Submitted That Met QC Criteria

August 14, 2021

First Posted (Actual)

August 23, 2021

Study Record Updates

Last Update Posted (Actual)

March 4, 2022

Last Update Submitted That Met QC Criteria

March 3, 2022

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCN-FoU-24000473

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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