Clinical Trials Directory

Trials / Completed

CompletedNCT03682523

The Breaking "Bad Rest" Study: Interrupting Sedentary Time to Reverse Frailty Levels in Acute Care

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
50 (actual)
Sponsor
Olga Theou · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

Summary

This study will determine whether an intervention aimed at reducing sedentary time in patients admitted to acute care will result in decreased frailty levels at hospital discharge, compared to the current standard of care. All patients will be fitted with accelerometers then randomised to the control or intervention group. The control group will receive only standard of care while in hospital. Participants in the intervention group will engage in daily goal setting for time out-of-bed and have access to real-time feedback on a bedside monitor. Participants in the intervention group will also received assisted mobilization if they have not met their daily goal by the late afternoon. The main outcome is frailty, assessed by a frailty index.

Detailed description

The objective of this study is to determine if an intervention designed to reduce sedentary time during a patient's stay in acute care will reduce patient's frailty levels more so than current standard of care. This study will be conducted at a single-centre, but will be a stratified, block randomised control trial. Fifty participants will be recruited within 24 hours of admission to a geriatric acute care unit. Both groups will be fitted with a device that measures sedentary and active time (accelerometer). Participants in the intervention group will have a daily goal for activity and will be provided with real-time feedback on attainment of that goal displayed on a bedside tablet. Participants in the intervention group who do not independently achieve their goal will be assisted in reducing their sedentary time in the afternoon and/or early evening to the maximum level of their ability; this level will be determined in consultation with the healthcare team. The primary outcome is a change in frailty during hospitalization, measured using a 30-item frailty index. The data collection phase is approximately 10 months. Data analysis will take an additional six months (16 months total). Knowledge-users will be involved during all stages of the project. The data generated from this study will enable us to scale up this intervention nationally and internationally. If the intervention is successful, it will warrant a study to implement the intervention as part of standard care. Ultimately, this study will inform guidelines to limit patients' sedentary behaviors in acute care.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSedentary behavior reduction interventionParticipants will be provided with a device to measure physical activity and sedentary behaviours. A tablet will be in the research office and each afternoon, it will be synced to the device to assess the activity progress of the patient. The research team will deliver an upright time goal and will target a 20% increase in upright time from the previous hospital day. Physiotherapist research assistants will visit the participants every afternoon to monitor progress and safely mobilize participants to their maximum ability if they have not met their daily goal (including weekend). The maximum level of ability will be determined in consultation with the healthcare team. Participants who do not meet their goal will be mobilized in the late afternoon/ early evening.

Timeline

Start date
2022-04-07
Primary completion
2023-07-20
Completion
2023-07-20
First posted
2018-09-24
Last updated
2023-08-30

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT03682523. Inclusion in this directory is not an endorsement.