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Trial record 58 of 45988 for:    intensity

High-intensity Training, Self-monitoring and Diabetes 2

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ClinicalTrials.gov Identifier: NCT03159494
Recruitment Status : Completed
First Posted : May 18, 2017
Last Update Posted : February 12, 2018
Sponsor:
Collaborator:
Aalborg University
Information provided by (Responsible Party):
University College of Northern Denmark

Brief Summary:
10 patients with type 2 diabetes participated in a training-intervention consisting of 8 times of High-Intensity Training (HIT). Before and after the intervention the patients were tested regarding Oral Glucose Tolerance Test, blood pressure, weight and fat% and VO2max. A pilot study was conducted with 6 patients with type 2 diabetes using the same protocol but only 6 times of training.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus High-Intensity Interval Training Self Care Other: High-Intensity Training Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A pilot group of 6 patients with type 2 diabetes tested before and after 6 times of High Intensity Training One group of patients with type 2 diabetes tested before and after 8 times of High Intensity Training.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Self-monitoring Approach in Evaluating the Effect of 3 Weeks of High-Intense Interval Training in Type 2 Diabetics
Actual Study Start Date : February 14, 2014
Actual Primary Completion Date : November 13, 2015
Actual Study Completion Date : November 13, 2015

Arm Intervention/treatment
Experimental: Intervention group
10 patients with type 2 diabetes enrolled to perform 8 times of High-Intensity Training. The subjects were tested before and after the training period.
Other: High-Intensity Training

8 times of Hit consisting of 3 minutes of Warm-up on an indoor bike followed by 10 intervals of 1 minute at 90% og HRmax interspersed of 1 minute of recovery.

As for the pilot study 6 times of training were completed


Experimental: Pilot study
6 patients with type 2 diabetes enrolled to perform 6 times of High-Intensity Training. The subjects were tested before and after the training period
Other: High-Intensity Training

8 times of Hit consisting of 3 minutes of Warm-up on an indoor bike followed by 10 intervals of 1 minute at 90% og HRmax interspersed of 1 minute of recovery.

As for the pilot study 6 times of training were completed





Primary Outcome Measures :
  1. Fasting glucose concentration [ Time Frame: Through study completion, an average of 3 weeks ]
    A small blood sample was collected by the use of a finger prick to determine fasting capillary blood glucose level (mmol/l) by a glucose meter (Accu Check)

  2. 2-hour glucose concentration [ Time Frame: Through study completion, an average of 3 weeks ]
    The participants were instructed to drink 75 mg of glucose dissolved in 300 ml of water. Blood samples were collected after 30, 60, 90 and 120 minutes with the use of finger prick and blood concentrations were measured by a glucose meter (Accu Check)

  3. Weight [ Time Frame: Through study completion, an average of 3 weeks ]
    Weight measured i kilograms on a Tanita digital scale without shoes

  4. Fat percent [ Time Frame: Through study completion, an average of 3 weeks ]
    A Tanita digital scale with bioelectric impedance was used to measured fat percent (%)

  5. Oxygen consumption [ Time Frame: Through study completion, an average of 3 weeks ]
    Bicycle test on a Lode ergometer bike to exhaustion with direct measurement of oxygen consumption by Breath-by-breath on Masterscreen CPX. The participants were instructed about the protocol before applying the equipment used for the test. Then there was a warm-up for 5 min. on 50-75 watt followed by incremental increase in intensity by 25 watt each minute until exhaustion. The outcome was measured in l/min and ml/kg/min

  6. Training intensity [ Time Frame: Through study completion, an average of 3 weeks ]
    The training intensity measured i % of max heart rate and Borg´s rate of perceived exhaustion was made for each interval (10 intervals/training, 8 times of training)

  7. Blood pressure [ Time Frame: Through study completion, an average of 3 weeks ]
    Blood pressure was measured after 10 min of rest in a sitting position. An automatic blood pressure monitor was used and three measures were made. The lowest of the three values were used in calculations.


Secondary Outcome Measures :
  1. Physical acitity [ Time Frame: At baseline ]
    The participants level of physical activity (measured in MET´s) was calculated by the use of the Physical Activity Scale (Aadahl M & Joergensen T, 2003)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed type 2 diabetes
  • Approved to participate by own general practitioner

Exclusion Criteria:

  • Conditions contraindicating training at high intensity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03159494


Sponsors and Collaborators
University College of Northern Denmark
Aalborg University
Investigators
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Principal Investigator: Ole K Hejlesen, Professor Medical Informatics, Aalborg University, Denmark

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Responsible Party: University College of Northern Denmark
ClinicalTrials.gov Identifier: NCT03159494     History of Changes
Other Study ID Numbers: FOU-PHD-007
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No