Promoting physical activity in adults with high blood pressure through eHealth
| ISRCTN | ISRCTN14808838 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14808838 |
| Sponsor | Center for Clinical Research Dalarna |
| Funders | Vetenskapsrådet, Centrum fÖr Klinisk Forskning Dalarna |
- Submission date
- 02/02/2026
- Registration date
- 03/02/2026
- Last edited
- 04/02/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Promoting physical activity is an important lifestyle intervention for preventing and managing disease. Supporting individuals with lifestyle-related conditions, such as high blood pressure, to reach the physical activity levels recommended by the World Health Organization is therefore a public health priority.
This study aims to evaluate the effects of a physical activity promotion intervention in Swedish primary healthcare for patients with high blood pressure. The intervention includes both counselling sessions with a healthcare professional and the use of an app, called ProMotion, which is designed to support physical activity.
Who can participate?
Adults aged 18–85 years and being insufficiently physically active who have recently (≤3 months) been diagnosed with high blood pressure by primary healthcare.
What does the study involve?
All participants in the study will receive a physical activity promotion intervention. The intervention is delivered in two phases (B-C). In Phase B, participants will monitor their physical activity in a diary for 4 weeks. In Phase C, participants will use an app designed for physical activity promotion in combination with counselling with a healthcare professional for 8 weeks. Before the intervention, all participants will be assigned to one of three baseline phases (either two, three or four weeks long). Physical activity will be measured by a thigh-worn accelerometer during all three phases and compared between the phases.
What are the possible benefits and risks of participating?
Participants will receive support to increase physical activity, which may contribute to lower blood pressure and improved overall health. In addition, participants will receive a detailed and individualized description of their physical activity patterns over an extended period. Together, the detailed information on physical activity patterns and the use of an app for physical activity promotion are intended to increase participants’ understanding of their own behaviour change processes.
Physical activity may cause temporary muscle soreness or pain and, in rare cases, injury. Participants will have access to a trained healthcare professional to minimize these risks. The study will collect personal and health data, which may pose a privacy risk. All data handling will follow strict ethical principles and data regulations to protect participants’ integrity.
Where is the study run from?
Center for Clinical Research Dalarna, Falun, Sweden
When is the study starting and how long is it expected to run for?
Expected start of data collection: February 16, 2026.
Expected final enrolment: April 16, 2026
Who is funding the study?
Center for Clinical Research Dalarna (Sweden)
The Swedish Research Council
Who is the main contact?
Douglas Anderson Åhlfeldt
daf@du.se
Contact information
Principal investigator, Scientific, Public
791 88 Falun
Falun
SE-791 88
Sweden
 ORCID ID |
0009-0005-6043-7364 |
|---|---|
| Phone | +46 703669023 |
| daf@du.se |
Scientific, Public
Center for Clinical Research Dalarna, Uppsala University, Nissers Väg 3
Falun
SE-791 82
Sweden
| ORCID ID |
0000-0002-8709-4446 |
|---|---|
| Phone | +46 730-818201 |
| catharina.gustavsson@regiondalarna.se |
Public, Scientific
Mora Hospital
Mora
SE‑792 85
Sweden
| ORCID ID |
0000-0003-1730-3131 |
|---|---|
| Phone | +46 735546945 |
| linda.a.pettersson@regiondalarna.se |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Non-randomized controlled trial | |
| Masking | Open (masking not used) | |
| Control | Historical | |
| Assignment | Single | |
| Purpose | Health services research, Treatment | |
| Scientific title | ProMotion - effects on physical activity by an eHealth intervention for physical activity promotion for adults with hypertension: protocol for a single case experimental design | |
| Study objectives | This study aims to evaluate the effects of a behaviour change intervention integrating the eHealth service ProMotion for person-centred physical activity promotion with conventional care in primary healthcare (PHC) among patients recently diagnosed with hypertension. The study will examine how the intervention affects the primary outcome variable, physical activity, and the secondary outcome variable, blood pressure. Furthermore, it will explore patients' experience of the eHealth service ProMotion and how patients engage with and use the eHealth service. Research questions: 1. How does the intervention affect physical activity in terms of type of activity, duration, and intensity: -When the patients use self-monitoring of physical activity? -When the patients use the first version of the eHealth service ProMotion? 2. How does the intervention affect blood pressure in patients with hypertension? 3. How do patients with hypertension perceive the usability of a first version of the eHealth service ProMotion? 4. How do patients with hypertension engage with the app and the webpage of the eHealth service ProMotion? | |
| Ethics approval(s) |
Approved 19/01/2026, Swedish Ethical Review Authority (Box 2110, Uppsala, 750 02, Sweden; +46 10-475 08 00; registrator@etikprovning.se), ref: 2025-08644-01 | |
| Health condition(s) or problem(s) studied | Physical activity promotion in patients with hypertension | |
| Intervention | This study uses a single case experimental design with multiple baselines. All study participants received a physical activity promotion intervention, including the eHealth service ProMotion specifically designed to facilitate behaviour change. The study includes three phases: a baseline phase A and two intervention phases B and C. The multiple-baseline approach allows for experimental control at the individual level by systematically staggered introduction of intervention phases. The participants are randomly assigned to one of three baseline lengths (two, three or four weeks). During phase A, participants receive only the instruction to continue living their lives as usual. Physical activity is measured using a thigh-worn accelerometer throughout the study. Blood pressure is measured at the beginning of each phase (A–C) and again at the end of the intervention period. During intervention phase B, participants are instructed to self-monitor their physical activity for four weeks as a stand-alone behaviour change technique. Physical activity is recorded in a diary, including the type of activity (e.g., cycling, gardening, walking), duration (minutes), and perceived level of exertion (the Borg Rating of Perceived Exertion Scale). Intervention phase C lasts for eight weeks and includes the introduction and use of the Promotion eHealth service specifically designed to promote physical activity. It incorporates multiple behaviour change techniques, such as goal setting and action planning, self-monitoring of behaviour and outcomes, feedback, and social support. In addition, participants receive traditional physical activity promotion through counselling with a designated healthcare professional, delivered using motivational interviewing principles. All participants attend an introductory meeting with their healthcare professional at the start of phase C and are offered follow-up meetings by convenience during the intervention phase C. | |
| Intervention type | Behavioural | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) |
| |
| Completion date | 01/09/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 85 Years |
| Sex | All |
| Target sample size at registration | 12 |
| Key inclusion criteria | 1. Persons aged 18-85 years with a recent diagnosis (≤3 months) of the ICD-10 diagnosis I10.9 Hypertension (≥140/90 mmHg) 2. Cared for at one of the participating primary health care centers 3. Has access to a smartphone or tablet 4. Reports spending less than 150 minutes on leisure time PA, i.e sports or exercise, on moderate intensity during an ordinary week |
| Key exclusion criteria | 1. Hypertension ≥180/110 mmHg 2. Short life expectancy (<6 months) due to serious illness 3. Predicted inability to comply with study protocol due to cognitive impairment, such as dementia 4. Insufficient ability to understand written Swedish |
| Date of first enrolment | 16/02/2026 |
| Date of final enrolment | 16/04/2026 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Hede
846 31
Sweden
Sveg
842 32
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated and analysed during the current study will be available upon reasonable request from Ass. Prof. Dr Catharina Gustavsson, email address: catharina.gustavsson@regiondalarna.se Pseudonymised datasets can be requested by researchers who can show adequate ethical approval for the purposes of replicating the analyses, confirming or refuting the study findings, or inclusion in systematic reviews and meta-analyses. Types of data that can be shared include: • Accelerometer derived physical activity data (Microsoft Excel format) • Blood pressure measurements (Microsoft Excel format) • Self administered questionnaire data on perceived usability and exercise self efficacy (Microsoft Excel format) All shared datasets will be pseudonymised in accordance with ethical and legal requirements, including GDPR. Research data will be stored securely for a minimum of ten years in compliance with Swedish legislation. |
Editorial Notes
NHW 04/02/2026: Internal review.
02/02/2026: Trial's existence confirmed by Swedish Ethical Review Authority.
