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

NCT ID: NCT03682523

Last Updated: 2023-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-07

Study Completion Date

2023-07-20

Brief Summary

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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

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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

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Sedentary Lifestyle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be classified into three strata based on their baseline mobility measured with the HABAM. Within each strata, patients will be randomly allocated to the control (n=25) and intervention (n=25) groups in temporal blocks. In the event of Covid-19 related interruptions to the study, temporal blocks aim to keep the number of participants in the intervention and control groups similar at all times.

This stratified, block randomised control trial design will ensure a similar distribution of patient characteristics in the control and intervention groups and will safeguard against possible interruptions due to Covid-19.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
A senior statistician will use a computer-generated random sequence to determine whether each patient is allocated to the control or intervention group. To minimize risk of bias, the RA who collects assessment data will remain blinded to the study group, with separate RAs assisting with the intervention. Only the statistician will hold the key to the control/intervention group.

Study Groups

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Control Group

Fitted with an accelerometer to measure time spent out of bed while in hospital. Otherwise, participants in the control group will receive usual care from the hospital medical team during their hospital stay. Daily activities of participants will not be restricted if patients are assigned to the control group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Group

Fitted with accelerometer to measure time spent out of bed while in hospital; daily goals set for time spent out of bed; mobilization feedback real-time feedback on goal attainment; hands on mobilization by physiotherapist for participants in late afternoon for participants who do not meet daily goal.

Group Type EXPERIMENTAL

Sedentary behavior reduction intervention

Intervention Type BEHAVIORAL

Participants 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.

Interventions

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Sedentary behavior reduction intervention

Participants 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Anticipated hospital length of stay \>1 day
* Patient or care partner able to communicate in English

Exclusion Criteria

* Patient unable to provide informed consent and care partner not available to provide consent
* Bedridden prior to hospital admission
* Previous participation in our study (i.e. readmission during data collection phase)
* End-of-life or waiting for long-term care facility
* Patient is admitted to a shared room with a current study participant.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Olga Theou

OTHER

Sponsor Role lead

Responsible Party

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Olga Theou

PhD, Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Olga Theou, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor, Department of Medicine, Dalhousie University

Locations

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QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Site Status

Countries

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Canada

References

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Other Identifiers

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Breaking Bad Rest

Identifier Type: -

Identifier Source: org_study_id

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