Clinical Trials Logo

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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03166852
Study type Interventional
Source University College of Northern Denmark
Contact
Status Completed
Phase N/A
Start date April 27, 2016
Completion date November 27, 2016

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05666479 - CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
Completed NCT05647083 - The Effect of Massage on Diabetic Parameters N/A
Active, not recruiting NCT05661799 - Persistence of Physical Activity in People With Type 2 Diabetes Over Time. N/A
Completed NCT03686722 - Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin Phase 1
Completed NCT02836704 - Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose) Phase 4
Completed NCT01819129 - Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes Phase 3
Completed NCT04562714 - Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy N/A
Completed NCT02009488 - Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM) Phase 1
Completed NCT05896319 - Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2 N/A
Recruiting NCT05598203 - Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes N/A
Completed NCT05046873 - A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People Phase 1
Completed NCT04030091 - Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus Phase 4
Terminated NCT04090242 - Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes N/A
Completed NCT03604224 - A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
Completed NCT03620357 - Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D) N/A
Completed NCT01696266 - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Completed NCT03620890 - Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy Phase 4
Withdrawn NCT05473286 - A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
Not yet recruiting NCT05029804 - Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes N/A
Completed NCT04531631 - Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes Phase 2