Sedentary LifestyleNCT03682523
The Breaking "Bad Rest" Study: Interrupting Sedentary Time to Reverse Frailty Levels in Acute Care
A study testing Sedentary behavior reduction intervention in people with Sedentary Lifestyle, run by Olga Theou at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- Sedentary behavior reduction intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 7 Apr 2022to 20 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Anticipated hospital length of stay >1 day
- Patient or care partner able to communicate in English
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Sedentary Lifestyle
- Being tested
- Sedentary behavior reduction intervention
- Keywords
- Frailty, Hospitalization, Acute care, older adults, intervention
- Medical subject headings
- Sedentary Behavior, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedentary behavior reduction interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Sedentary behavior reduction intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline frailty up to a median 14 day hospital length of stay
Secondary outcomes (11)
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. Secondary outcome for the FI is a change from baseline up to one month following hospital discharge as a continuous measure.
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.
Measured: Change from baseline frailty up to a median 14 days hospital length of stay, and 30 days after hospital discharge
Change in upright time
Time (minutes/day) spent upright out of bed (upright time) will be tracked continuously during the participants' hospital length of stay using accelerometers for both groups. Patients will be fitted with accelerometers within 24 hours of admission. An ActivatorTM (PAL Technologies Ltd) accelerometer will be attached to the mid-thigh of the patients' dominant side.
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.
Measured: Change from baseline upright time up to a median 14 day hospital length of stay
Change in upright bouts
The number of times/day that a participants gets upright out of bed (upright bouts) will be tracked continuously during the participants' hospital length of stay using accelerometers for both groups. Patients will be fitted with accelerometers within 24 hours of admission. An ActivatorTM (PAL Technologies Ltd) accelerometer will be attached to the mid-thigh of the patients' dominant side.
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.
Measured: 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)
The HABAM is a clinical tool used to obtain a global measure of a patients' health through the assessment of mobility, transfers and balance. Patients receive daily scores based on demonstrated ability in each focal area; testing if the patient can move around in bed, sit up in bed, stand up, etc. The median hospital length of stay is expected to be 14 days, but many patients will have a longer length of stay. This means that some patients will have more data collection time points than others.
Measured: 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)
The HABAM is a clinical tool used to obtain a global measure of a patients' health through the assessment of mobility, transfers and balance. Patients receive daily scores based on demonstrated ability in each focal area; testing if the patient can move around in bed, sit up in bed, stand up, etc. The median hospital length of stay is expected to be 14 days, but many patients will have a longer length of stay. This means that some patients will have more data collection time points than others.
Measured: Change from baseline balance scores up to a median 14 day hospital length of stay
Falls
The number of falls will be assessed by reviewing medical charts during hospitalization and by self-report at the one month follow-up.
Measured: From baseline to 30 days after hospital discharge
Hospital length of stay
Medical chart reviews will be assessed to measure hospital length of stay
Measured: From baseline up to a median 14 day hospital length of stay
In-hospital mortality
Medical chart reviews will be assessed to measure in-hospital mortality
Measured: From baseline up to a median 14 day hospital length of stay
Hospital readmissions
Medical chart reviews will be assessed to measure readmissions within 30 days.
Measured: From baseline up to 30 days after hospital discharge
Safety evaluation (frequency of adverse events)
Safety will be determined through medical chart audit for frequency of adverse events
Measured: From baseline up to a median 14 day hospital length of stay
Cost
Costs (Canadian Dollars) related to the interventions will be collected prospectively from the intervention accounts and costs incurred by the healthcare system and patients will be collected through interviews and follow-up surveys, respectively. An appropriate decision-analytic modeling framework will be employed to undertake cost-effectiveness analyses.
Measured: From baseline up to 30 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start7 Apr 2022
- Primary completion20 Jul 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olga Theou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Olga Theou, Nova Scotia Health Authority
- Investigators
- Olga Theou, PhD, Principal investigator, Assistant Professor, Department of Medicine, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682523
- Sponsor's protocol ID
- Breaking Bad Rest
- Status last verified
- Aug 2023
- First submitted
- 12 Sep 2018
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hoogerduijn JG, Buurman BM, Korevaar JC, Grobbee DE, de Rooij SE, Schuurmans MJ. The prediction of functional decline in older hospitalised patients. Age Ageing. 2012 May;41(3):381-7. doi: 10.1093/ageing/afs015. Epub 2012 Feb 28.
PubMed 22378613Covinsky KE, Palmer RM, Fortinsky RH, Counsell SR, Stewart AL, Kresevic D, Burant CJ, Landefeld CS. Loss of independence in activities of daily living in older adults hospitalized with medical illnesses: increased vulnerability with age. J Am Geriatr Soc. 2003 Apr;51(4):451-8. doi: 10.1046/j.1532-5415.2003.51152.x.
PubMed 12657063Chong E, Ho E, Baldevarona-Llego J, Chan M, Wu L, Tay L. Frailty and Risk of Adverse Outcomes in Hospitalized Older Adults: A Comparison of Different Frailty Measures. J Am Med Dir Assoc. 2017 Jul 1;18(7):638.e7-638.e11. doi: 10.1016/j.jamda.2017.04.011. Epub 2017 Jun 3.
PubMed 28587850Romero-Ortuno R, Forsyth DR, Wilson KJ, Cameron E, Wallis S, Biram R, Keevil V. The Association of Geriatric Syndromes with Hospital Outcomes. J Hosp Med. 2017 Feb;12(2):83-89. doi: 10.12788/jhm.2685.
PubMed 28182802Romero-Ortuno R, Wallis S, Biram R, Keevil V. Clinical frailty adds to acute illness severity in predicting mortality in hospitalized older adults: An observational study. Eur J Intern Med. 2016 Nov;35:24-34. doi: 10.1016/j.ejim.2016.08.033. Epub 2016 Sep 2.
PubMed 27596721Baldwin C, van Kessel G, Phillips A, Johnston K. Accelerometry Shows Inpatients With Acute Medical or Surgical Conditions Spend Little Time Upright and Are Highly Sedentary: Systematic Review. Phys Ther. 2017 Nov 1;97(11):1044-1065. doi: 10.1093/ptj/pzx076.
PubMed 29077906Kortebein P, Ferrando A, Lombeida J, Wolfe R, Evans WJ. Effect of 10 days of bed rest on skeletal muscle in healthy older adults. JAMA. 2007 Apr 25;297(16):1772-4. doi: 10.1001/jama.297.16.1772-b. No abstract available.
PubMed 17456818Lipnicki DM, Gunga HC. Physical inactivity and cognitive functioning: results from bed rest studies. Eur J Appl Physiol. 2009 Jan;105(1):27-35. doi: 10.1007/s00421-008-0869-5. Epub 2008 Sep 17.
PubMed 18797919Kortebein P, Symons TB, Ferrando A, Paddon-Jones D, Ronsen O, Protas E, Conger S, Lombeida J, Wolfe R, Evans WJ. Functional impact of 10 days of bed rest in healthy older adults. J Gerontol A Biol Sci Med Sci. 2008 Oct;63(10):1076-81. doi: 10.1093/gerona/63.10.1076.
PubMed 18948558Aguilar-Farias N, Brown WJ, Peeters GM. ActiGraph GT3X+ cut-points for identifying sedentary behaviour in older adults in free-living environments. J Sci Med Sport. 2014 May;17(3):293-9. doi: 10.1016/j.jsams.2013.07.002. Epub 2013 Aug 8.
PubMed 23932934Egerton T, Brauer SG, Cresswell AG. Fatigue after physical activity in healthy and balance-impaired elderly. J Aging Phys Act. 2009 Jan;17(1):89-105. doi: 10.1123/japa.17.1.89.
PubMed 19299841Tremblay MS, Carson V, Chaput JP, Connor Gorber S, Dinh T, Duggan M, Faulkner G, Gray CE, Gruber R, Janson K, Janssen I, Katzmarzyk PT, Kho ME, Latimer-Cheung AE, LeBlanc C, Okely AD, Olds T, Pate RR, Phillips A, Poitras VJ, Rodenburg S, Sampson M, Saunders TJ, Stone JA, Stratton G, Weiss SK, Zehr L. Canadian 24-Hour Movement Guidelines for Children and Youth: An Integration of Physical Activity, Sedentary Behaviour, and Sleep. Appl Physiol Nutr Metab. 2016 Jun;41(6 Suppl 3):S311-27. doi: 10.1139/apnm-2016-0151.
PubMed 27306437Shadmi E, Zisberg A. In-hospital mobility and length of stay. Arch Intern Med. 2011 Jul 25;171(14):1298; author reply 1298-9. doi: 10.1001/archinternmed.2011.321. No abstract available.
PubMed 21788551Brown CJ, Williams BR, Woodby LL, Davis LL, Allman RM. Barriers to mobility during hospitalization from the perspectives of older patients and their nurses and physicians. J Hosp Med. 2007 Sep;2(5):305-13. doi: 10.1002/jhm.209.
PubMed 17935241Liu B, Moore JE, Almaawiy U, Chan WH, Khan S, Ewusie J, Hamid JS, Straus SE; MOVE ON Collaboration. Outcomes of Mobilisation of Vulnerable Elders in Ontario (MOVE ON): a multisite interrupted time series evaluation of an implementation intervention to increase patient mobilisation. Age Ageing. 2018 Jan 1;47(1):112-119. doi: 10.1093/ageing/afx128.
PubMed 28985310
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Breaking "Bad Rest" Study: Interrupting Sedentary Time to Reverse Frailty Levels in Acute Care
- ClinicalTrials.gov ID
- NCT03682523
- Acronym / sponsor ID
- Breaking Bad Rest
- Conditions
- Sedentary Lifestyle
- Keywords
- Frailty, Hospitalization, Acute care, older adults, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Olga TheouUniversity, hospital or other
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 24 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Sedentary behavior reduction interventionFitted 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Anticipated hospital length of stay >1 day
- Patient or care partner able to communicate in English
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sedentary 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. | Behavioural | Intervention Group |
Primary outcome
Change in the Frailty Index
Time frame: Change from baseline frailty up to a median 14 day hospital length of stay
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.
11 secondary outcomes
Change in the Frailty Index
Time frame: Change from baseline frailty up to a median 14 days hospital length of stay, and 30 days after hospital discharge
Change in upright time
Time frame: Change from baseline upright time up to a median 14 day hospital length of stay
Change in upright bouts
Time frame: 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)
Time frame: 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)
Time frame: Change from baseline balance scores up to a median 14 day hospital length of stay
Falls
Time frame: From baseline to 30 days after hospital discharge
Hospital length of stay
Time frame: From baseline up to a median 14 day hospital length of stay
In-hospital mortality
Time frame: From baseline up to a median 14 day hospital length of stay
Hospital readmissions
Time frame: From baseline up to 30 days after hospital discharge
Safety evaluation (frequency of adverse events)
Time frame: From baseline up to a median 14 day hospital length of stay
Cost
Time frame: From baseline up to 30 days after hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Background: PubMed 22378613Hoogerduijn JG, Buurman BM, Korevaar JC, Grobbee DE, de Rooij SE, Schuurmans MJ. The prediction of functional decline in older hospitalised patients. Age Ageing. 2012 May;41(3):381-7. doi: 10.1093/ageing/afs015. Epub 2012 Feb 28.
- Background: PubMed 12657063Covinsky KE, Palmer RM, Fortinsky RH, Counsell SR, Stewart AL, Kresevic D, Burant CJ, Landefeld CS. Loss of independence in activities of daily living in older adults hospitalized with medical illnesses: increased vulnerability with age. J Am Geriatr Soc. 2003 Apr;51(4):451-8. doi: 10.1046/j.1532-5415.2003.51152.x.
- Background: PubMed 28587850Chong E, Ho E, Baldevarona-Llego J, Chan M, Wu L, Tay L. Frailty and Risk of Adverse Outcomes in Hospitalized Older Adults: A Comparison of Different Frailty Measures. J Am Med Dir Assoc. 2017 Jul 1;18(7):638.e7-638.e11. doi: 10.1016/j.jamda.2017.04.011. Epub 2017 Jun 3.
- Background: PubMed 28182802Romero-Ortuno R, Forsyth DR, Wilson KJ, Cameron E, Wallis S, Biram R, Keevil V. The Association of Geriatric Syndromes with Hospital Outcomes. J Hosp Med. 2017 Feb;12(2):83-89. doi: 10.12788/jhm.2685.
- Background: PubMed 27596721Romero-Ortuno R, Wallis S, Biram R, Keevil V. Clinical frailty adds to acute illness severity in predicting mortality in hospitalized older adults: An observational study. Eur J Intern Med. 2016 Nov;35:24-34. doi: 10.1016/j.ejim.2016.08.033. Epub 2016 Sep 2.
- Background: PubMed 29077906Baldwin C, van Kessel G, Phillips A, Johnston K. Accelerometry Shows Inpatients With Acute Medical or Surgical Conditions Spend Little Time Upright and Are Highly Sedentary: Systematic Review. Phys Ther. 2017 Nov 1;97(11):1044-1065. doi: 10.1093/ptj/pzx076.
- Background: PubMed 17456818Kortebein P, Ferrando A, Lombeida J, Wolfe R, Evans WJ. Effect of 10 days of bed rest on skeletal muscle in healthy older adults. JAMA. 2007 Apr 25;297(16):1772-4. doi: 10.1001/jama.297.16.1772-b. No abstract available.
- Background: PubMed 18797919Lipnicki DM, Gunga HC. Physical inactivity and cognitive functioning: results from bed rest studies. Eur J Appl Physiol. 2009 Jan;105(1):27-35. doi: 10.1007/s00421-008-0869-5. Epub 2008 Sep 17.
- Background: PubMed 18948558Kortebein P, Symons TB, Ferrando A, Paddon-Jones D, Ronsen O, Protas E, Conger S, Lombeida J, Wolfe R, Evans WJ. Functional impact of 10 days of bed rest in healthy older adults. J Gerontol A Biol Sci Med Sci. 2008 Oct;63(10):1076-81. doi: 10.1093/gerona/63.10.1076.
- Background: PubMed 23932934Aguilar-Farias N, Brown WJ, Peeters GM. ActiGraph GT3X+ cut-points for identifying sedentary behaviour in older adults in free-living environments. J Sci Med Sport. 2014 May;17(3):293-9. doi: 10.1016/j.jsams.2013.07.002. Epub 2013 Aug 8.
- Background: PubMed 19299841Egerton T, Brauer SG, Cresswell AG. Fatigue after physical activity in healthy and balance-impaired elderly. J Aging Phys Act. 2009 Jan;17(1):89-105. doi: 10.1123/japa.17.1.89.
- Background: PubMed 27306437Tremblay MS, Carson V, Chaput JP, Connor Gorber S, Dinh T, Duggan M, Faulkner G, Gray CE, Gruber R, Janson K, Janssen I, Katzmarzyk PT, Kho ME, Latimer-Cheung AE, LeBlanc C, Okely AD, Olds T, Pate RR, Phillips A, Poitras VJ, Rodenburg S, Sampson M, Saunders TJ, Stone JA, Stratton G, Weiss SK, Zehr L. Canadian 24-Hour Movement Guidelines for Children and Youth: An Integration of Physical Activity, Sedentary Behaviour, and Sleep. Appl Physiol Nutr Metab. 2016 Jun;41(6 Suppl 3):S311-27. doi: 10.1139/apnm-2016-0151.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olga Theou, PhD principal investigator
Assistant Professor, Department of Medicine, Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sedentary behavior reduction intervention in people with Sedentary Lifestyle, run by Olga Theou at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Frailty Index (time frame: Change from baseline frailty up to a median 14 day hospital length of stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03682523, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.