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

About this trial
This is an interventional health services research trial for Diabetes Mellitus, Type 2
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
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
NCT ID
NCT03166852
First Posted
May 23, 2017
Last Updated
May 24, 2017
Sponsor
University College of Northern Denmark
Collaborators
Aalborg University
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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Compliance to HIT-program at Home With the Use of Technology
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