Heart-eXg Study: Effects of Exergaming to Reduce Sedentary Time in Inactive Patients With Heart Failure: An International Multi-center, Randomized, Parallel-group Study

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this to determine the effect of tailored exergaming for inactive patients with heart failure to reduce their sedentary time, improve their daily physical activity, exercise capacity, decrease frailty and improve health-related quality of life. Participants will, on a background of standard guideline-directed medical therapy patients, be randomised to tailored activity advice (control) or the Heart-Exergame (Heart-eXg) intervention for a period of 3 months. Patients randomised to the Heart-eXg group will receive an exergame with feedback and tailoring to adapt the exergaming advice. Patients will also be able to play with a person in their own network.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosed with symptomatic HF (NYHA II-IV) as diagnosed by cardiologist, (independent of Ejection Fraction: Patients with a preserved ejection fraction (HFpEF), mid-range ejection fraction (HFmrREF) or reduced ejection fraction (HFrEF) can be included.

• Clinically stable

• Physically inactive

• Older than 18 years, there is no upper age limit,

• Speak/understand the language of the country where the study is taking place.

• Wanting to use a smartphone for the study (if patients do not have a smartphone, they can borrow it from the study team for the duration of the study)

Locations
Other Locations
Slovakia
P. J. Safarik University
ACTIVE_NOT_RECRUITING
Norrköping
Spain
Germans Trias i Pujol Hospital
RECRUITING
Barcelona
Hospital de Bellvitge
RECRUITING
Barcelona
Hospital del Mar
ACTIVE_NOT_RECRUITING
Barcelona
Xarxa Assistencial Universitaria
RECRUITING
Manresa
INCLIVA
RECRUITING
Valencia
Sweden
Jönköping Hospital Rydhov
RECRUITING
Jönköping
Kalmar Länssjukhuset
RECRUITING
Kalmar
Linköping University Hospital
RECRUITING
Linköping
Primary Health Care Centers Östergötland
RECRUITING
Norrköping
Contact Information
Primary
Tiny Jaarsma, PhD
tiny.jaarsma@liu.se
+46011363550
Time Frame
Start Date: 2022-05-16
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 750
Treatments
Experimental: Exergame group
Patients will be introduced to the exergame and the exergame will be installed following a protocol either by the patients themselves or an instructor of the study.~Patients will be advised to exergame daily based on their activity monitor reading at baseline and based on their current activity level and preferences.~During the 3 months of active intervention patients will receive feedback on their activity level and data will also be shared with the coach who will use it to adapt the gaming advice. A clear exergaming goal will be set together by patient and coach. In the first month, they will receive weekly feedback on their performance based on the readings from the activity monitor and the reading from the exergame. In the rest of the active study team the frequency of the contact with the coach will be personalized.
No_intervention: Control group
Patients will receive a protocol-based activity advice (one time) from the HF team (nurse, cardiologist and/or physiotherapist) that corresponds to the intervention group in terms of time and effort. Participants in the control group are encouraged to decrease their sedentary behaviour to the same extent as the intervention group, and if possible be physical active 30 minutes for 5 days a week.
Related Therapeutic Areas
Sponsors
Leads: Linkoeping University

This content was sourced from clinicaltrials.gov