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Compliance to HIT-program at Home With the Use of Technology

Primary Purpose

Diabetes Mellitus, Type 2, Exercise, Technology

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Home-training
Sponsored by
University College of Northern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus, Type 2

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed type 2 diabetics
  • In possession of a smartphone Approval from own general practitioner

Exclusion Criteria:

  • Conditions contraindicating high-intensity training

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Home-training group

    Arm Description

    High-intensity training at home 3 times/week for 5 weeks

    Outcomes

    Primary Outcome Measures

    Intensity of training
    Is it possible for type 2 diabetics to reach a high intensity on their own?
    Frequency of training
    How often do they train on their own?

    Secondary Outcome Measures

    Diabetes Attitude Score
    Questionaire to measure their attitude towards diabetes
    Health Literacy
    Questionaire
    Interview
    A semi-structured interview evaluating experiences from the study, including the use of equipment, training-method etc.

    Full Information

    First Posted
    May 23, 2017
    Last Updated
    May 24, 2017
    Sponsor
    University College of Northern Denmark
    Collaborators
    Aalborg University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03166852
    Brief Title
    Compliance to HIT-program at Home With the Use of Technology
    Official Title
    Compliance to HIT-program at Home With the Use of Technology
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 27, 2016 (Actual)
    Primary Completion Date
    November 27, 2016 (Actual)
    Study Completion Date
    November 27, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University College of Northern Denmark
    Collaborators
    Aalborg University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    High-intensity training (HIT) has showed beneficial effects in type 2 diabetics such as improved glycemic control, improved bloodpressure and more. In addition, HIT is a time-saving training protocol which is of importance, as lack of time often is mentioned as a reason not to train. The combination of the time-saving HIT-protocol and the possibility to train at home and still get feedback on the intensity and amount of training can be appealing for some. This study aims to investigate whether it is possible to train at the right intensity and frequency and only get feedback throug a technology.
    Detailed Description
    Participants: Patients with diagnosed type 2 diabetes recruited through local papers and Facebook. The participants receives both oral and written information before signing a written consent. Pretest Each participant participate in a 1½ hour long pretest in which basic information is collected. This information include gender, age, weight, height, diabetes-age, marital status, medicine and education/job. Furthermore they complete two questionnaires; the Diabetes Attitude Scale(DAS) and Health Literacy. The pretest-session ends with a VO2max test to find the participants maximal heart rate and their maximal oxygen consumption. Before leaving an appointment is made on when to get a visit at home with the purpose to get instructions on how to train and get the equipment. DAS The questionnaire consisted of 33 statements divided into subgroups. The participant is instructed to consider each statement in terms of how much they agree with the statement and they is instructed to answer all the questions. A higher score overall indicates a positive attitude towards diabetes and the result can also be viewed as results in subgroups. Health Literacy Health Literacy is found using the Danish TOFHLA (Test Of Functional Health Literacy in Adults). The Danish TOFHLA consists of a 17-item numeracy part and 50-item reading comprehension part. The numeracy part of the Danish TOFHLA assesses the participant's ability to understand financial assistance, keep a clinical appointment, understand instructions for taking medication, etc. In the Danish TOFHLA, the test of reading comprehension is conducted as a modified cloze procedure in which random words are deleted from a reading passage (31). In this case, every fifth to seventh word is deleted in healthrelated reading passages, and the participant then selects the most fitting word from a list of four possible words. The total scores for the Danish TOFHLA test are divided into three levels: inadequate (score: 0-59), marginal (score: 60-74) and adequate (score 75-100). VO2max Bicycle test to exhaustion with direct measurement of oxygen consumption by Breath-by-breath on Masterscreen CPX. Warm-up for 5 min. on 50-75 watt followed by incremental increase in intensity by 25 watt each minute until exhaustion. The test is qualified as a VO2max test if Respiratory Exchange Ratio (RER) exceeded 1,1. Otherwise it was categorized as a VO2peak. Training The participants is instructed to train 3 times/week for 5 weeks. Before each training a HR-sensor (Polar H7 Smart Bluetooth) is applied and connected to Endomondo via their smartphone. The training consists of 10 x 60 sec work on a bike at an intensity of ~90% of max HR interspersed by 60 sec of recovery sessions. The HR used for training is calculated based on the max HR found by VO2max test at pretest. Feedback At Mondays, Wednesdays and Fridays the participants gets feedback via Endomondo. The feedback focuses on the intensity and frequency of training. If no training is logged for a week the participant will be contacted through mail. Interview At the end of the training period the equipment is obtained and a semi-structured interview performed and taped on a dictaphone (app). The interview is classified into three areas: The training, the use of the equipment and the feedback. The interview is then transcribed and analyzed in NVIVO. A phenomenological approach is chosen as the interest is focused on the individuals experiences of the phenomenon and thereby describe the phenomenon

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2, Exercise, Technology

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    One group performs HIT with techology-based feedback for 5 weeks and the next group do the same
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    21 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Home-training group
    Arm Type
    Experimental
    Arm Description
    High-intensity training at home 3 times/week for 5 weeks
    Intervention Type
    Other
    Intervention Name(s)
    Home-training
    Intervention Description
    5 weeks of interval training at home. The training consisted of 3 minutes of warm-up. 10 intervals of 1 minute at 90% of maxHR interspersed with one minute of low intensity pedalling. Cool-down period of 2 minutes.
    Primary Outcome Measure Information:
    Title
    Intensity of training
    Description
    Is it possible for type 2 diabetics to reach a high intensity on their own?
    Time Frame
    Through study completion, an average of 5 weeks
    Title
    Frequency of training
    Description
    How often do they train on their own?
    Time Frame
    Through study completion, an average of 5 weeks
    Secondary Outcome Measure Information:
    Title
    Diabetes Attitude Score
    Description
    Questionaire to measure their attitude towards diabetes
    Time Frame
    At baseline
    Title
    Health Literacy
    Description
    Questionaire
    Time Frame
    At baseline
    Title
    Interview
    Description
    A semi-structured interview evaluating experiences from the study, including the use of equipment, training-method etc.
    Time Frame
    At study completion (After 5 weeks of training)

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosed type 2 diabetics In possession of a smartphone Approval from own general practitioner Exclusion Criteria: Conditions contraindicating high-intensity training
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ole K Hejlesen, Professor
    Organizational Affiliation
    Medical Informatics, Aalborg University, Denmark
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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