Effects of a map-based personalized intervention to promote walking in older adults

ISRCTN ISRCTN17473086
DOI https://doi.org/10.1186/ISRCTN17473086
Secondary identifying numbers 1782
Submission date
19/11/2024
Registration date
22/11/2024
Last edited
22/11/2024
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English Summary

Background and study aims
There is growing evidence that even low-intensity physical activity (e.g., walking at a “normal” pace) produces substantial health benefits. Walking is “universally accessible”, even for mobility-limited and chronically ill older people. To date, little consideration has been given to the environment and individual preferences of older people when promoting walking. A personalized approach based on geographic information systems (GIS) could help address the problem of low long-term adherence to walking programs. MOBITEC-Routes aims to investigate the effects of individualized, map-based walking promotion for mobility-limited and chronically ill older adults on walking (average steps/day) and further health-related parameters after 15 weeks of intervention (primary aim) and another 8 months of follow-up.

Who can participate?
Inactive, mobility-limited, community-dwelling older adults aged 65+ years old

What does the study involve?
Assessment of outcome parameters will take place at baseline, after a 15-week intervention period and after another 8 months of follow-up. The experimental intervention will offer personalized promotion of habitual walking, delivered by an exercise professional in face-to-face and telephone sessions. Opportunities to increase leisure and utilitarian walking will be identified by using interactive digital maps and a map-based activity plan will be set up. Behaviour change strategies (according to the HAPA model) will be employed. The control intervention will include general information on determinants of health (including sedentary behaviour, physical activity, sleep and nutrition) provided by an exercise professional. The primary outcome is walking (average steps per day) measured by accelerometry. Secondary outcomes include time spent lying, sitting, standing and stepping (accelerometry); physical function (battery of functional tests); real-life mobility (GPS and self-report); health-related quality of life (self-report); fall-related self-efficacy (self-report); active aging (self-report); and constructs of the Health Action Process Approach (HAPA) model (self-report). Statistical comparisons between the experimental and control groups will be undertaken.

What are the possible benefits and risks of participating?
The intervention focuses on the promotion of walking at the participant's comfortable, habitual walking speed (equivalent to “low-intensity” physical activity); i.e., the cardiovascular or musculoskeletal risk does not exceed the risk of usual everyday life. The benefits of the intervention are expected to outweigh the potential risks.

Where is the study run from?
The Department of Sport, Exercise and Medicine, University of Basel, Switzerland

When is the study starting and how long is it expected to run for?
December 2023 to September 2027

Who is funding the study?
Velux Stiftung, Switzerland

Who is the main contact?
Dr Timo Hinrichs (Principal Investigator), timo.hinrichs@unibas.ch

Study website

Contact information

Dr Timo Hinrichs
Public, Scientific, Principal Investigator

Department of Sport, Exercise and Health (DSBG)
University of Basel
Basel
4052
Switzerland

ORCiD logoORCID ID 0000-0001-6200-307X
Phone +41 61 207 47 43
Email timo.hinrichs@unibas.ch

Study information

Study designProspective two-arm single-centre randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Community, Internet/virtual, Telephone
Study typePrevention
Participant information sheet Not available in web format, please use contact details to request a participant information sheet.
Scientific titleIncreasing habitual walking by promoting purposeful activities in the neighbourhood: effects of a personalized, GIS-based intervention for mobility-limited and chronically ill older adults
Study acronymMOBITEC-Routes
Study hypothesisMOBITEC-Routes aims to assess the effects of an individualized, map-based habitual walking programme for mobility-limited and chronically ill older adults on walking (average steps/day) after 15 weeks of intervention (primary objective) and after another 8 months of follow-up. The main hypothesis is that the experimental intervention (individualized, map-based promotion of walking at habitual, comfortable speed) is more effective for increasing walking (average steps/day) than the control intervention (general health information).
Ethics approval(s)

Approved 19/11/2024, Ethics Committee of Northwestern and Central Switzerland (EKNZ) (Tellplatz 11, Basel, 4053, Switzerland; +41 61 268 13 50; eknz@bs.ch), ref: 2024-02094

ConditionThe study targets the walking behavior of inactive, mobility-limited, community-dwelling older adults aged 65+.
InterventionThe study is designed as a prospective, two-arm randomized controlled trial (single-centre). Balanced permuted block randomization with variable block sizes will be used to allocate participants to groups (ratio 1:1). Assessment of outcome parameters will take place at baseline, after a 15-week intervention period and after another 8 months of follow-up.

The experimental intervention includes a 15-week personalized counseling program aimed at promoting walking at a normal, comfortable speed. The program is delivered by an exercise professional through in-person and phone sessions. Using digital geographical maps, the sessions jointly explore opportunities to increase both leisure and utilitarian walking and create individualized route plans and walking schedules. Additionally, behavior change strategies are employed.

The control intervention focuses on giving general information on determinants of health. Topics include, e.g., sedentary behavior, physical activity, sleep, and nutrition. In contrast to the experimental intervention, no behavior change strategies are applied.
Intervention typeBehavioural
Primary outcome measureAverage steps per day are measured using an accelerometry at baseline (T0), directly after the 15-week intervention period (T1) and after another 8 months of follow-up (T2)
Secondary outcome measuresThe following secondary outcome measures will be assessed at baseline (T0), directly after the 15-week intervention period (T1) and after another 8 months of follow-up (T2):
1. Time spent lying, sitting, standing and stepping (and the respective bout lengths) measured using an accelerometry over 7 days
2. Real-life mobility measured using GPS over 7 days and by the University of Alabama at Birmingham Life Space Assessment
3. Physical function measured using the following battery of functional tests:
3.1. Standing balance measured using postural sway during 10s of semi-tandem stance on a force platform
3.2. Lower body strength measured using a timed test of 5 sit-to-stand repetitions on a force platform
3.3. Habitual and maximum walking speed measured using 10m walks using a light barrier system
3.4. Basic functional mobility and coordination measured using timed up-and-go test
4. Health-related quality of life measured by the Medical Outcomes Study 36-item Short-Form Survey
5. Active aging measured using the University of Jyvaskyla Active Aging Scale
6. Fear of falling measured using the Falls Efficacy Scale – International Version
7. Health behavior change measured using a self-report based on the constructs of the Health Action Process Approach model

Overall study start date01/12/2023
Overall study end date30/09/2027

Eligibility

Participant type(s)Patient
Age groupSenior
Lower age limit65 Years
SexBoth
Target number of participants130
Participant inclusion criteria1. Age 65 years and older
2. Living in own home
3. Self-reported mobility limitation, defined as at least “some difficulty” in either walking 2 km or climbing one flight of stairs
4. Ability to walk short distances outdoors (minimum 200 metres)
5. At least one chronic disease according to the “Self-Administered Comorbidity Questionnaire” (SCQ): heart disease, high blood pressure, lung disease, diabetes, ulcer or stomach disease, kidney disease, anemia or other blood diseases, cancer, depression, osteoarthritis, degenerative arthritis, back pain and/or rheumatoid arthritis
6. Medical clearance by study physician
7. Written informed consent
Participant exclusion criteria1. Inability to attend or complete the proposed course of intervention
2. Having a second home location and regularly spending more than 2 days per week at the second location
3. Being a spouse or living in the same household as a study participant
4. Regularly performing exercises, sporting activities or leisure activities of at least moderate intensity for more than 2 hours per week
6. Walking outdoors for more than 3 hours per week
7. High risk for adverse events related to physical activity (based on the study physician’s judgement); medical exclusion criteria include: untreated arterial hypertension or significantly elevated resting blood pressure (>180/100 mmHg) despite antihypertensive medication; higher-level chronic heart failure (New York Heart Association (NYHA) class III-IV); higher-level chronic obstructive pulmonary disease (Global Initiative for Obstructive Lung Disease (GOLD) stage IV); acute psychiatric disorder (e.g. severe depression); advanced terminal illness; having suffered a clinically relevant cardiovascular event (e.g. unstable angina pectoris, myocardial infarction, coronary angiography and/or angioplasty), a clinically relevant cerebrovascular event (e.g. stroke, recurrent TIA), or deterioration of insufficiently controlled diabetes within the previous 3 months; a HbA1c >10% (if available); or having suffered an injurious fall requiring medical treatment within the past 12 months.
8. On-going rehabilitation measures following an inpatient surgical procedure
9. Concurrent participation in another clinical trial
Recruitment start date02/12/2024
Recruitment end date30/09/2026

Locations

Countries of recruitment

  • Switzerland

Study participating centre

Department of Sport, Exercise and Health (DSBG), University of Basel
Grosse Allee 6
Basel
4052
Switzerland

Sponsor information

University of Basel
University/education

Department of Sport, Exercise and Health (DSBG), Grosse Allee 6
Basel
4052
Switzerland

Phone +41 61 207 47 79
Email sekretariat-dsbg@unibas.ch
Website https://dsbg.unibas.ch/de/
ROR logo "ROR" https://ror.org/02s6k3f65

Funders

Funder type

Research organisation

Velux Stiftung

No information available

Results and Publications

Intention to publish date30/09/2028
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in peer-reviewed journal
IPD sharing planThe data sets generated and/or analyzed during the current study will be available upon request from (PD Dr. Timo Hinrichs, timo.hinrichs@unibas.ch).

Editorial Notes

22/11/2024: Study's existence confirmed by the Ethics Committee of Northwestern and Central Switzerland (EKNZ).