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

NCT03682523 | Completed

• 1 other identifier: Breaking Bad Rest
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sedentary Lifestyle

Keywords

Frailty; Hospitalization; Acute care; older adults; intervention

Outcome Measures

Primary Outcomes (1)

• Change in the Frailty Index

  The frailty index (FI) operationalizes frailty in clinical practice and for research. FI scores are calculated as the proportion of potential deficits present in a given individual. For this study we will construct a 30-item FI using a health questionnaire administered to patients or their care partners (if patients are not able to self-report) at each study time point. The proportion of patients changing their FI scores by \>=0.1 from baseline to hospital discharge is the primary outcome. Data collection is opportunistic, based on length of stay. The discharge date is not fixed - thus day-in-study at discharge will not be the same for all participants. Depending on length of stay, participants will provide data for additional time points between baseline and discharge, including week 1, week 2, week 3, week 4 and then in 30 day intervals. However, not every participant will have the same number of time points. Note that the median hospital length of stay is 14 days.

  Change from baseline frailty up to a median 14 day hospital length of stay

Secondary Outcomes (11)

• Change in the Frailty Index

  Change from baseline frailty up to a median 14 days hospital length of stay, and 30 days after hospital discharge

• Change in upright time

  Change from baseline upright time up to a median 14 day hospital length of stay

• Change in upright bouts

  Change from baseline upright bouts up to a median 14 day hospital length of stay

• Change in mobility: Hierarchical Assessment of Balance and Mobility (HABAM)

  Change from baseline mobility scores up to a median 14 day hospital length of stay

• Change in balance: Hierarchical Assessment of Balance and Mobility (HABAM)

  Change from baseline balance scores up to a median 14 day hospital length of stay

Study Arms (2)

Control Group

NO INTERVENTION

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.

Intervention Group

EXPERIMENTAL

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.

Behavioral: Sedentary behavior reduction intervention

Interventions

Sedentary behavior reduction intervention 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.

Intervention Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Olga Theou: lead

Study Sites (1)

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Location

Related Publications (29)

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  PMID: 21584244 RESULT

• Theou O, O'Brien MW, Godin J, Blanchard C, Cahill L, Hajizadeh M, Hartley P, Jarrett P, Kehler DS, Romero-Ortuno R, Visvanathan R, Rockwood K. Interrupting bedtime to reverse frailty levels in acute care: a study protocol for the Breaking Bad Rest randomized controlled trial. BMC Geriatr. 2023 Aug 10;23(1):482. doi: 10.1186/s12877-023-04172-x.

  PMID: 37563553 DERIVED

MeSH Terms

Conditions

Sedentary Behavior; Frailty

Condition Hierarchy (Ancestors)

Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Olga Theou, PhD

  Assistant Professor, Department of Medicine, Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: September 24, 2018
• Study Start: April 7, 2022
• Primary Completion: July 20, 2023
• Study Completion: July 20, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

CA (1)