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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03166852
• Other study ID #: FOU-PHD-005
• Status: Completed
• Phase: N/A
• First received: May 23, 2017
• Last updated: May 24, 2017
• Start date: April 27, 2016
• Est. completion date: November 27, 2016

Study information

• Verified date: May 2017
• Source: University College of Northern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 27, 2016
• Est. primary completion date: November 27, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosed type 2 diabetics

• In possession of a smartphone Approval from own general practitioner

Exclusion Criteria:

• Conditions contraindicating high-intensity training

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Exercise
• Technology

Intervention

Other:
• Home-training
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University College of Northern Denmark	Aalborg University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensity of training	Is it possible for type 2 diabetics to reach a high intensity on their own?	Through study completion, an average of 5 weeks
Primary	Frequency of training	How often do they train on their own?	Through study completion, an average of 5 weeks
Secondary	Diabetes Attitude Score	Questionaire to measure their attitude towards diabetes	At baseline
Secondary	Health Literacy	Questionaire	At baseline
Secondary	Interview	A semi-structured interview evaluating experiences from the study, including the use of equipment, training-method etc.	At study completion (After 5 weeks of training)