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NCT Number: NCT05015946

Handball-based Exercise and Type 2 Diabetes

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.

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Key information

Conditions

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

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Department of Physiotherapy, University College of Northern Denmark

Aalborg, 9210, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with type 2 diabetes
  • Understands and speaks danish

Exclusion criteria

  • If General Practitioner do not recommend participation in the intervention

Treatment and study plan

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.

Primary outcomes

  1. Concentration of Hemoglobin A1c (HbA1c) (mmol/mol)

    Time frame: change from baseline to 12 weeks

    HbA1c measured with HemoCue HbA1c 501

  2. Peak oxygen uptake (VO2peak)

    Time frame: change from baseline to 12 weeks

    Peak oxygen uptake measured with incremental cycling test

  3. 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)

Secondary outcomes

  1. 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

  2. Body mass index (BMI)

    Time frame: change from baseline to 12 weeks

    Body mass index measured by kg/M2

  3. Body fat mass (kg)

    Time frame: change from baseline to 12 weeks

    Total body fat in kg measured with Tanita MC-180MA, Tokyo, Japan

  4. Lean body mass (kg)

    Time frame: change from baseline to 12 weeks

    Lean body mass in kg measured with Tanita MC-180MA, Tokyo, Japan

  5. 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.

  6. 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

  7. Aerobic performance test (aerobic endurance)

    Time frame: change from baseline to 12 weeks

    Aerobic endurance measured with Intermittent Recovery Test Level 1

  8. Self-care behavior

    Time frame: change from baseline to 12 weeks

    Self-care behavior measured with diabetes Intention, Attitude, and Behavior Questionnaire (DIAB-Q)

  9. Physical activity levels

    Time frame: change from baseline to 12 weeks

    Physical activity scale (PAS)

  10. 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.

Sponsors and collaborators

Lead sponsor

University College of Northern Denmark

Other

Collaborators

  • Danish Handball Federation
  • Research Unit for General Practice in Aalborg
  • The Danish Diabetes Association

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 23, 2021
Registry last updated
Mar 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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