The effectiveness of smartphone app guided interval-walking training compared to continuous aerobic walking training for people with type 2 diabetes or prediabetes. A pilot study.
Organizational Data
- DRKS-ID:
- DRKS00016370
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2019-03-07
- Last update in DRKS:
- 2019-05-27
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
The aim of this study is to evaluate the effectiveness of an outdoor smartphone app guided interval-walking training in terms of body measurements, fitness capacity and improvements in quality of life for people with type 2 diabetes or a pre-stage of it. Moreover, the purpose is to investigate whether interval walking-training is more effective in comparison to a continuous walking-training. During the training phase the interval-walking group is going to complete a walking training of 30 minutes, 3 times per week for 4 weeks. The intervals consist of 3 minutes blocks of fast walking, followed by 3 minutes of slower walking. The training is guided by 2 physiotherapists 2 times per week and once per week the individuals have to perform the training by themselves. The continuous walking group is going to walk 30 minutes at a medium pace 3 times per week for 4 weeks. The training is guided by 2 physiotherapist 2 times per week and once per week the individuals have to perform the training by themselves.
Brief summary in scientific language
The primary outcome of this pilot study is to assess the feasibility of the study design that is key to the success of a future large-scale study. The secondary outcome is a comparison between the effects of a smartphone app guided outdoor interval walking-training and a continuous aerobic walking-training in terms of anthropometric measurements (WtHR, weight), aerobic capacity (6-MWT) and improvements in quality of life (SF-36). This RCT includes patients with type 2 diabetes or prediabetes, as diagnosed by a MD. If subjects fulfil the inclusion criteria, they will be randomly assigned to one of the two training groups. The interval-walking group is going to complete a walking training of 30 minutes, 3 times per week for 4 weeks. The intervals contain blocks of 3 minutes of high intensity, followed by 3 minutes of lower intensity. The training is guided by 2 physiotherapists 2 times per week and once per week the individuals have to perform the training by themselves. The continuous walking group (control group) is going to walk 30 minutes at a medium pace 3 times per week for 4 weeks. The training is guided by 2 physiotherapist 2 times per week and once per week the individuals have to perform the training by themselves.
Health condition or problem studied
- ICD10:
- E11 - Type 2 diabetes mellitus
- Free text:
- Type 2 diabetes, prediabetes
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- The smartphone app assisted interval-walking group is going to complete a walking training of 30 minutes, 3 times per week for 4 weeks. The intervals contain blocks of 3 minutes of high intensity, followed by 3 minutes of lower intensity walking. The training is guided by 2 physiotherapists 2 times per week and once per week the individuals have to perform the training by themselves (preferable on the weekend).
- Arm 2:
- The continuous walking group (control group) is going to walk 30 minutes at a medium pace 3 times per week for 4 weeks. The training is guided by 2 physiotherapists 2 times per week and once per week the individuals have to perform the training by themselves (preferable on the weekend).
Endpoints
- Primary outcome:
- The primary outcome of this pilot study is to assess the feasibility of the study design that is key to the success of a large-scale study. The feasibility factors of the study design are measured by reasons for exclusion, recruitment rate, reasons for dropouts, patients’ satisfaction, intensity of the training method, missing data, estimated sample size. The feasibility factors will be measured during the whole study time and are assessed by descriptive statistics, questionnaires and interviews.
- Secondary outcome:
- The secondary outcome is a comparison between the effects of a smartphone app guided outdoor interval walking-training and a continuous aerobic walking-training in terms of anthropometric measurements (WtHR, weight), aerobic capacity (6-MWT) and improvements in quality of life (SF-36) in patients with type 2 diabetes or prediabetes. These measurements will take place at baseline and after 4 weeks of training.
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Switzerland
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Other Physiotherapiepraxis Luzern
Recruitment period and number of participants
- Planned study start date:
- 2019-03-07
- Actual study start date:
- 2019-03-07
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 20
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 99 Years
- Additional Inclusion Criteria:
- Participants fulfilling all of the following inclusion criteria are eligible for the study: • Informed Consent as documented by signature • Individuals with type 2 diabetes or prediabetes diagnosed by a GP • Ability to walk 30 min continuously • Ability to read and speak German fluently • No contraindication, which prohibit physical activity • Owning a smartphone (Apple / Android)
Exclusion Criteria
The presence of any one of the following exclusion criteria will lead to exclusion of the participant: • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. • Patients receiving long-term insulin and/or sulfonylurea treatment • Contraindication, which prohibit physical activity (e.g. uncontrolled arterial hypertension, limited cardiac insufficiency) • Limiting musculoskeletal disorders, which prohibit the participation (Injury in lower limbs, painful osteoarthritis etc.) • No informed consent • <18 years of age
Addresses
Primary Sponsor
- Address:
- Gesundheitspraxis Löwen Center AGJosé van der HoefZürichstrasse 96004 LuzernSwitzerland
- Telephone:
- 00 41 41 410 69 40
- Fax:
- 00 41 41 410 69 43
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.physio-luzern.ch
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Gesundheitspraxis Löwen Center AGBSc, cand MSc Franziska VoigtZürichstrasse 96004 LuzernSwitzerland
- Telephone:
- 00 41 41 410 69 40
- Fax:
- 00 41 41 410 69 43
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.physio-luzern.ch
Contact for Public Queries
- Address:
- Gesundheitspraxis Löwen Center AGBSc, cand MSc Franziska VoigtZürichstrasse 96004 LuzernSwitzerland
- Telephone:
- 00 41 41 410 69 40
- Fax:
- 00 41 41 410 69 43
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.physio-luzern.ch
Principal Investigator
- Address:
- Gesundheitspraxis Löwen Center AGBSc, cand MSc Franziska VoigtZürichstrasse 96004 LuzernSwitzerland
- Telephone:
- 00 41 41 410 69 40
- Fax:
- 00 41 41 410 69 43
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.physio-luzern.ch
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Gesundheitspraxis Löwen Center AGZürichstrasse 96004 LuzernSwitzerland
- Telephone:
- 0041 41 410 69 40
- Fax:
- 0041 41 410 69 43
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.physio-luzern.ch
Ethics Committee
Address Ethics Committee
- Address:
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2018-12-19
- Ethics committee number:
- 2018-02061
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2019-01-11
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- Prüfprotokoll
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry