Clinical trial NCT04555330: Technology Assisted Physical Activity Among Hospitalised Medical Patients
Official title: Technology Assisted Physical Activity Among Hospitalised Medical Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease
Cardiac Disease
Geriatric Disease
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 354
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The allocation of participants will be done in 8 waves at each of the participating wards. At each hospital ward, 4 of the waves will be allocated to the control group and 4 to the intervention group. The order of the conditions is randomised.

A participant will be assigned to the wave that the ward is allocated to at the time of admission.

The wave size for each ward is set to 10 patients.

Assignment of the waves at each department will be determined before any recruitment by means of Latin square randomisation in 2 blocks of 4 waves at the 4 participating wards.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Research show that inactivity during hospitalization is the norm and that the negative effects on muscle mass and the fitness of the patient will take a long time and hard work to recover afterwards.

Especially for weaker elderly patients, just a few days in bed could mean that they are not able to take care of themselves afterwards, with increased care expenses and increased risk of relapse as a consequence. Even though this is known, the work to motivate patients to be active during their hospitalization is limited to few training sessions with only the most vulnerable patients. No tools are today available for objectively tracking and motivating patients to be active during their stay. Having such a professional tool would not only motivate but also shift the attention of the health professionals towards the importance of physical activity in the treatment of the patient.

The aim of the studys is to investigate if patients hospitalised for medical disease will increase their time spent out of bed during hospitalisation through simple visual feedback about physical activities from a mobile bedside device.

Detailed description: The study will be conducted as a quasi-randomised trial using a large tertiary public hospital in Copenhagen, Denmark. Patients admitted to Department of Respiratory Medicine (2 wards), Department of Cardiology, and Department of Geriatrics will be included, and they will have their physical activity level measured either with or without a bedside monitor providing visual feedback of time spent bedridden, sitting, standing and walking.

All participants will have their physical activity measured during hospitalisation. Approximately half of the participants will receive visual feedback about the amount of physical activity from a mobile device placed on the bedside table.

Eligibility criteria: INCLUSION CRITERIA

An individual will be eligible for study participation if he/she meets the following criteria:

1. Is admitted to one of the participating departments
2. Has signed informed consent
3. Reads and speaks Danish

EXCLUSION CRITERIA

An individual will be excluded from the study if he/she meets any of the following criteria:

1. Any condition that, in the opinion of the investigator, makes the person unfit for participation
2. Expected hospitalisation less than 24 hours
3. Has no independent ambulatory abilities (e.g. wheel chair user)
4. Needs personal assistance in body transfers and ambulation (Cumulated Ambulation Score 0, 1, 2, or 3)
5. Has allergy towards band aid

Primary outcomes:
measure: Time spent out of bed measured in minutes related to the total accelerometer wear time (minutes).
timeFrame: Through hospital stay, on average between 1 and 7 days
Secondary outcomes:
measure: Time spent lying down, measured in minutes related to the total accelerometer wear time (minutes).
timeFrame: Through hospital stay, on average between 1 and 7 days
measure: Time spent sitting measured in minutes related to the total accelerometer wear time (minutes).
timeFrame: Through hospital stay, on average between 1 and 7 days
measure: Time spent standing measured in minutes related to the total accelerometer wear time (minutes).
timeFrame: Through hospital stay, on average between 1 and 7 days
measure: Time spent walking measured in minutes related to the total accelerometer wear time (minutes).
timeFrame: Through hospital stay, on average between 1 and 7 days
measure: Length of stay
timeFrame: Time from hospital admission to hospital discharge
measure: Readmission to hospital
timeFrame: within 90 days
measure: In-hospital fall incidents
timeFrame: Through hospital stay, on average between 1 and 7 days
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital, Department of Physical and Occupational Therapy
Study officials:
References: