NCT05235763: HEALTHY

Heart Failure Activity Coach Study

Completed NA Last updated 24 October 2023

What this trial tests

NA trial testing activity coach in Physical Inactivity in 20 participants. Completed in 1 September 2023.

Timeline

1 June 2022

Primary endpoint
30 July 2023

1 September 2023

Quick facts

Lead sponsor	CareLigo AB
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	20
Start date	1 June 2022
Primary completion	30 July 2023
Estimated completion	1 September 2023
Sites	1 location across Sweden

Drugs / interventions tested

• activity coach
• sham activity coach

Conditions studied

• Physical Inactivity — all drugs for Physical Inactivity →
• Heart Failure — all drugs for Heart Failure →

Sponsor

CareLigo AB

Who can join

18 and older, any sex, with Physical Inactivity or Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

An application (app) called the activity coach will be tested to see if it can increase physical activity and decrease sedentary behaviuor, as well as increase quality of life and lead to personal goal attainment in physically inactive heart failure (HF) patients. This pilot randomized controlled trial (RCT) will test the study design and recruitment process, as well as outcomes for a future efficacy RCT.

HF-patients equipped with the mHealth-tool Optilogg will be screened for physical inactivity and then recruited and randomized to either have the activity coach app added to their Optilogg or remain with the standard Optilogg. The study will go on for 12 weeks. Weeks 1 and 12 physical activity using an accelerometer will be recorded, as well as health-related quality of life. At the start of the study the patients will list goals relating to physical activity which the wish to attain, and the level of attainment will be evaluated at the end of the study.

The activity coach educated the patient about physical activity, offers means of manually tracking physical activity, and provides trends of registered activity. Furthermore, it provides weekly summaries of registered physical activity and provides means of setting goals for the following week.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Testing the Recruitment Frequency, Implementation Fidelity, and Feasibility of Outcomes of the Heart Failure Activity Coach Study (HEALTHY): Pilot Randomized Controlled Trial.
   Blomqvist A, Bäck M, Klompstra L, Strömberg A, et al · · 2025 · cited 4× · PMID 39778202 · DOI 10.2196/62910
2. Usability and feasibility analysis of an mHealth-tool for supporting physical activity in people with heart failure.
   Blomqvist A, Bäck M, Klompstra L, Strömberg A, et al · · 2024 · cited 3× · PMID 38347499 · DOI 10.1186/s12911-024-02452-z
3. Exploring user experience: A qualitative analysis of the use of a physical activity support app for people with heart failure.
   Blomqvist A, Strömberg A, Lundberg M, Bäck M, et al · · 2025 · cited 1× · PMID 40402948 · DOI 10.1371/journal.pone.0309577