<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03824106</url>
  </required_header>
  <id_info>
    <org_study_id>5500</org_study_id>
    <nct_id>NCT03824106</nct_id>
  </id_info>
  <brief_title>Frailty Rehabilitation</brief_title>
  <official_title>Frailty Rehabilitation: A Community-based Intervention to Promote Healthy Aging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McMaster University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Frailty is an important clinical state that contributes to falls, hospitalization,&#xD;
      institutionalization and death. When an individual simultaneously has many health problems, a&#xD;
      frailty &quot;tipping point&quot; may be triggered by even a minor stressful event such as adding a new&#xD;
      drug or urinary tract infection. Our research suggests that approximately 23% of Canadians&#xD;
      over age 65 are frail, and by age 85 this estimate increases to over 40%. As we learn more&#xD;
      about frailty and its consequences, there is an urgent need to develop community-based&#xD;
      interventions that will prevent or delay frailty in older adults. Our proposed study will&#xD;
      examine if frailty rehabilitation program is an effective community-based intervention to&#xD;
      promote healthy aging. The primary objective of our study is to determine if 4-month frailty&#xD;
      rehabilitation improves physical function compared with control and exercise alone in&#xD;
      community-dwelling older adults living with frailty and sarcopenia. Secondary objectives of&#xD;
      our study are to determine if 4-months of frailty rehabilitation can improve functional&#xD;
      abilities and reduce healthcare utilization during a 6-month follow-up period compared with&#xD;
      control and exercise alone. Results will translate the first Canadian model of frailty and&#xD;
      sarcopenia rehabilitation and management.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this multi-arm randomized controlled trial (RCT), 324 community-dwelling older adults&#xD;
      (aged 65+) with frailty and at high risk for mobility disability will be randomized into one&#xD;
      of three arms (control, exercise only, multi-modal rehabilitation) stratified by sex, age and&#xD;
      location preference. Rolling recruitment will occur with ten cohorts total (2-3 cohorts per&#xD;
      site, n=33 participants per cohort), enrolled across the partner Young Men's Christian&#xD;
      Association (YMCA) sites.&#xD;
&#xD;
      Building upon the RCT, we aim to understand which components of a functional rehabilitation&#xD;
      program are essential to change the trajectory of sarcopenia in older adults and explore the&#xD;
      feasibility of a functional rehabilitation program with older adults. All participants will&#xD;
      be screened for sarcopenia at baseline. Of the 324 participants, a subset of participants&#xD;
      with sarcopenia will undergo additional assessments.&#xD;
&#xD;
      A validated frailty questionnaire can be administered over the phone and will provide an&#xD;
      estimate of frailty status.&#xD;
&#xD;
      Stratified block randomization (1:1 randomization ratio) with the allocation sequence&#xD;
      generated by a computer will be used to randomly allocate eligible participants to their&#xD;
      group assignment. Participants will be stratified based on their sex, age (&lt;80 or &gt;=80&#xD;
      years), and location preference. To protect against selection bias, the randomization&#xD;
      sequence will be adequately concealed so that investigators/participants are not aware of the&#xD;
      upcoming assignment. The proposed duration of treatment is 4-months.&#xD;
&#xD;
      Primary and secondary outcomes will be assessed at 0 and 4-months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 2, 2022</start_date>
  <completion_date type="Anticipated">December 2, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 3, 2023</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Physical Performance</measure>
    <time_frame>Baseline and 4-months</time_frame>
    <description>Physical function will be assessed with the Short Performance Physical Battery [total score]. Higher scores indicate better physical performance [range 0-12].</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Walking Speed</measure>
    <time_frame>Baseline and 4-months</time_frame>
    <description>Walking speed will be assessed with the 400-m Walk Test [walking speed, m/s]. Faster walking speeds indicate better performance.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Frailty</measure>
    <time_frame>Baseline and 4-months</time_frame>
    <description>Frailty will be assessed with the Fit-Frailty App [total score]. Higher scores indicate greater frailty [range 0-1].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fear of Falling</measure>
    <time_frame>Baseline and 4-months</time_frame>
    <description>Iconographical Falls Efficacy Scale [total score]. Higher scores indicate greater fear of falling [range 16-28]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Balance Confidence</measure>
    <time_frame>Baseline and 4-months</time_frame>
    <description>Dichotomous questions (y/n)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Falls</measure>
    <time_frame>Baseline and 4-months</time_frame>
    <description>Number of falls will be assessed by self-report.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fitness</measure>
    <time_frame>Baseline and 4-months</time_frame>
    <description>Fitness will be assessed with Fitness Trackers [average step count per day]. A greater number of steps indicates higher fitness level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Strength</measure>
    <time_frame>Baseline and 4-months</time_frame>
    <description>Strength will be assessed with a handgrip dynamometer [kg].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Functional Mobility</measure>
    <time_frame>Baseline and 4-months</time_frame>
    <description>Strength will be assessed with the Timed Up and Go (TUG) Test [total time]. A higher score indicates a greater falls risk (greater or equal to 12 sec) and lower functional mobility.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cognition</measure>
    <time_frame>Baseline and 4-months</time_frame>
    <description>Cognition will be assessed with the Montreal Cognitive Assessment [total score]. Higher scores indicate better cognition [range 0-30].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cognition</measure>
    <time_frame>Baseline and 4-months</time_frame>
    <description>Cognition will be assessed with the Mini-Mental State Examination [total score]. Higher scores indicate better cognition [range 0-30].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Health-related Quality of Life</measure>
    <time_frame>Baseline and 4-months</time_frame>
    <description>Health-related quality of life will be assessed using a EuroQol instrument. Higher scores indicate better health-related quality of life [range 0-100].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Life Space Mobility</measure>
    <time_frame>Baseline and 4-months</time_frame>
    <description>Life space mobility will be assessed with the Life Space Assessment [total score]. Higher scores indicate a larger life space [range 0-120].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Basic Activities of Daily Living</measure>
    <time_frame>Baseline and 4-months</time_frame>
    <description>Activities of daily living will be assessed with the Katz activities of daily living questionnaire [total score]. Lower scores indicate greater impairment [range 0-6].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Instrumental Activities of Daily Living</measure>
    <time_frame>Baseline and 4-months</time_frame>
    <description>Activities of daily living will be assessed with Lawton instrumental activities of daily living questionnaire [total scores]. Lower scores indicate greater impairment [range 0-8].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Depression / Mood</measure>
    <time_frame>Baseline and 4-months</time_frame>
    <description>Depression and mood will be assessed with the Geriatric Depression Scale Short-Form [total score]. Higher scores indicate more depressive symptoms [range 0-15].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Nutrition</measure>
    <time_frame>Baseline and 4-months</time_frame>
    <description>Nutrition will be assessed with the Mini Nutritional Assessment [total score]. Lower scores indicate malnutrition [range 0-14].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sarcopenia</measure>
    <time_frame>Baseline and 4-months</time_frame>
    <description>Sarcopenia will be assessed with the strength, assistance walking, rise from a chair, climb stairs, and falls (SARC-F) questionnaire [total score]. High scores (greater than or equal to 4) is predictive of sarcopenia [range 0-10].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Muscle Mass</measure>
    <time_frame>Baseline and 4-months</time_frame>
    <description>Muscle mass will be assessed with dual-energy x-ray absorptiometry (DXA) and magnetic resonance imaging (MRI). A subset of participants will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Emergency Room Visits</measure>
    <time_frame>Baseline, 4-months and additional 6-month follow-up</time_frame>
    <description>Number of emergency room visits will be recorded. Higher number of emergency room visits indicates higher healthcare utilization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Hospitalizations</measure>
    <time_frame>Baseline, 4-months and additional 6-month follow-up</time_frame>
    <description>Number of hospitalizations will be recorded. Higher number of hospitalizations indicates higher healthcare utilization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Institutionalization</measure>
    <time_frame>Baseline, 4-months and additional 6-month follow-up</time_frame>
    <description>Institutionalization to long-term care will be recorded. Higher number individuals entering long-term care indicates higher healthcare utilization.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Individual-level Economic Evaluation</measure>
    <time_frame>Baseline, 4-months and additional 6-month follow-up</time_frame>
    <description>Individual-level economic evaluations will be assessed by changes in direct medical costs and effectiveness outcomes (e.g., quality-adjusted life years - QALYs), calculate and compare the incremental cost-effectiveness ratio (ICER) (e.g., $/ QALY gained, $/ a visit averted) against a willingness-to-pay threshold ($50,000/QALY) to show if this program of frailty rehabilitation represents good value for money.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">324</enrollment>
  <condition>Frailty</condition>
  <arm_group>
    <arm_group_label>Arm1.Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to the control arm will not receive any of the Frailty Rehabilitation Interventions. Participants in the control arm will receive Vitamin D.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm2.Group Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will attend the exercise program, twice-weekly, for 4-months with supplemental home exercise.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm3.Multi-modal Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group Exercise/Supplemental Home Exercise: This will be delivered identically to Arm 2.&#xD;
Nutrition, protein supplementation, and a medication review will also be implemented.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Participants randomized to the control arm will not receive any of the Frailty Management Interventions.</description>
    <arm_group_label>Arm1.Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group Exercise</intervention_name>
    <description>A recent meta-analysis suggests 180 min/week of exercise (with a high challenge to balance) is most effective for fall prevention. Combined strength and endurance training performed at a moderate weekly frequency (i.e., two times per week) may promote marked gains on muscle hypertrophy, strength and power gains in frail older adults. Balance training is a key component of successful exercise programs for vulnerable older adults.</description>
    <arm_group_label>Arm2.Group Exercise</arm_group_label>
    <arm_group_label>Arm3.Multi-modal Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Nutrition and Medication review</intervention_name>
    <description>Nutrition review: Conduct nutritional screening flow and review any questions, provide some additional counseling/coaching. Protein supplements will be provided to all participants unless contraindicated.&#xD;
Medication review: Review/update current medication list and forward the list and medical history to the consultant study pharmacist.</description>
    <arm_group_label>Arm3.Multi-modal Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Protein Supplement</intervention_name>
    <description>Protein supplementation will be provided.</description>
    <arm_group_label>Arm3.Multi-modal Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin D</intervention_name>
    <description>1000 IU of oral vitamin D</description>
    <arm_group_label>Arm1.Control</arm_group_label>
    <arm_group_label>Arm2.Group Exercise</arm_group_label>
    <arm_group_label>Arm3.Multi-modal Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Community-dwelling ≥65 years of age&#xD;
&#xD;
          -  Able to independently ambulate 25m with or without walking aid&#xD;
&#xD;
          -  At high risk for mobility disability/functional limitations&#xD;
&#xD;
          -  Received medical clearance&#xD;
&#xD;
          -  Can arrange transportation to the YMCA up to 2x/week&#xD;
&#xD;
          -  Proof of being fully vaccinated against COVID-19 and proof of identification&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to speak or understand English&#xD;
&#xD;
          -  Currently attending a group exercise program&#xD;
&#xD;
          -  Currently in a drug optimization study/program&#xD;
&#xD;
          -  Currently taking protein supplements daily&#xD;
&#xD;
          -  Significant cognitive impairment where they may have difficulty following two-step&#xD;
             commands in group exercise&#xD;
&#xD;
          -  Receiving palliative/end of life care&#xD;
&#xD;
          -  Unstable angina or heart failure&#xD;
&#xD;
          -  Unable to attend for more than 20% of trial duration&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexandra Papaioannou, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMaster University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sherri Smith</last_name>
    <phone>905 521 2100</phone>
    <phone_ext>77715</phone_ext>
    <email>smithsher@hhsc.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>McMaster University - St. Peter's Hospital</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8M1W9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sherri Smith</last_name>
      <phone>905 521 2100</phone>
      <phone_ext>77715</phone_ext>
      <email>smithsher@hhsc.ca</email>
    </contact>
    <investigator>
      <last_name>Alexandra Papaioannou, MD, MSc</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
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  <verification_date>September 2022</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>September 3, 2022</last_update_submitted>
  <last_update_submitted_qc>September 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Frailty</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03824106
org study id: 5500
nct id: NCT03824106
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Frailty is an important clinical state that contributes to falls, hospitalization,
      institutionalization and death. When an individual simultaneously has many health problems, a
      frailty "tipping point" may be triggered by even a minor stressful event such as adding a new
      drug or urinary tract infection. Our research suggests that approximately 23% of Canadians
      over age 65 are frail, and by age 85 this estimate increases to over 40%. As we learn more
      about frailty and its consequences, there is an urgent need to develop community-based
      interventions that will prevent or delay frailty in older adults. Our proposed study will
      examine if frailty rehabilitation program is an effective community-based intervention to
      promote healthy aging. The primary objective of our study is to determine if 4-month frailty
      rehabilitation improves physical function compared with control and exercise alone in
      community-dwelling older adults living with frailty and sarcopenia. Secondary objectives of
      our study are to determine if 4-months of frailty rehabilitation can improve functional
      abilities and reduce healthcare utilization during a 6-month follow-up period compared with
      control and exercise alone. Results will translate the first Canadian model of frailty and
      sarcopenia rehabilitation and management.
In this multi-arm randomized controlled trial (RCT), 324 community-dwelling older adults
      (aged 65+) with frailty and at high risk for mobility disability will be randomized into one
      of three arms (control, exercise only, multi-modal rehabilitation) stratified by sex, age and
      location preference. Rolling recruitment will occur with ten cohorts total (2-3 cohorts per
      site, n=33 participants per cohort), enrolled across the partner Young Men's Christian
      Association (YMCA) sites.

      Building upon the RCT, we aim to understand which components of a functional rehabilitation
      program are essential to change the trajectory of sarcopenia in older adults and explore the
      feasibility of a functional rehabilitation program with older adults. All participants will
      be screened for sarcopenia at baseline. Of the 324 participants, a subset of participants
      with sarcopenia will undergo additional assessments.

      A validated frailty questionnaire can be administered over the phone and will provide an
      estimate of frailty status.

      Stratified block randomization (1:1 randomization ratio) with the allocation sequence
      generated by a computer will be used to randomly allocate eligible participants to their
      group assignment. Participants will be stratified based on their sex, age (<80 or >=80
      years), and location preference. To protect against selection bias, the randomization
      sequence will be adequately concealed so that investigators/participants are not aware of the
      upcoming assignment. The proposed duration of treatment is 4-months.

      Primary and secondary outcomes will be assessed at 0 and 4-months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in Physical Performance
time frame: Baseline and 4-months
description: Physical function will be assessed with the Short Performance Physical Battery [total score]. Higher scores indicate better physical performance [range 0-12].
measure: Change in Walking Speed
time frame: Baseline and 4-months
description: Walking speed will be assessed with the 400-m Walk Test [walking speed, m/s]. Faster walking speeds indicate better performance.
measure: Change in Frailty
time frame: Baseline and 4-months
description: Frailty will be assessed with the Fit-Frailty App [total score]. Higher scores indicate greater frailty [range 0-1].
measure: Change in Fear of Falling
time frame: Baseline and 4-months
description: Iconographical Falls Efficacy Scale [total score]. Higher scores indicate greater fear of falling [range 16-28]
measure: Change in Balance Confidence
time frame: Baseline and 4-months
description: Dichotomous questions (y/n)
measure: Change in Falls
time frame: Baseline and 4-months
description: Number of falls will be assessed by self-report.
measure: Change in Fitness
time frame: Baseline and 4-months
description: Fitness will be assessed with Fitness Trackers [average step count per day]. A greater number of steps indicates higher fitness level.
measure: Change in Strength
time frame: Baseline and 4-months
description: Strength will be assessed with a handgrip dynamometer [kg].
measure: Change in Functional Mobility
time frame: Baseline and 4-months
description: Strength will be assessed with the Timed Up and Go (TUG) Test [total time]. A higher score indicates a greater falls risk (greater or equal to 12 sec) and lower functional mobility.
measure: Change in Cognition
time frame: Baseline and 4-months
description: Cognition will be assessed with the Montreal Cognitive Assessment [total score]. Higher scores indicate better cognition [range 0-30].
measure: Change in Cognition
time frame: Baseline and 4-months
description: Cognition will be assessed with the Mini-Mental State Examination [total score]. Higher scores indicate better cognition [range 0-30].
measure: Change in Health-related Quality of Life
time frame: Baseline and 4-months
description: Health-related quality of life will be assessed using a EuroQol instrument. Higher scores indicate better health-related quality of life [range 0-100].
measure: Change in Life Space Mobility
time frame: Baseline and 4-months
description: Life space mobility will be assessed with the Life Space Assessment [total score]. Higher scores indicate a larger life space [range 0-120].
measure: Change in Basic Activities of Daily Living
time frame: Baseline and 4-months
description: Activities of daily living will be assessed with the Katz activities of daily living questionnaire [total score]. Lower scores indicate greater impairment [range 0-6].
measure: Change in Instrumental Activities of Daily Living
time frame: Baseline and 4-months
description: Activities of daily living will be assessed with Lawton instrumental activities of daily living questionnaire [total scores]. Lower scores indicate greater impairment [range 0-8].
measure: Change in Depression / Mood
time frame: Baseline and 4-months
description: Depression and mood will be assessed with the Geriatric Depression Scale Short-Form [total score]. Higher scores indicate more depressive symptoms [range 0-15].
measure: Change in Nutrition
time frame: Baseline and 4-months
description: Nutrition will be assessed with the Mini Nutritional Assessment [total score]. Lower scores indicate malnutrition [range 0-14].
measure: Change in Sarcopenia
time frame: Baseline and 4-months
description: Sarcopenia will be assessed with the strength, assistance walking, rise from a chair, climb stairs, and falls (SARC-F) questionnaire [total score]. High scores (greater than or equal to 4) is predictive of sarcopenia [range 0-10].
measure: Change in Muscle Mass
time frame: Baseline and 4-months
description: Muscle mass will be assessed with dual-energy x-ray absorptiometry (DXA) and magnetic resonance imaging (MRI). A subset of participants will be assessed.
measure: Change in Emergency Room Visits
time frame: Baseline, 4-months and additional 6-month follow-up
description: Number of emergency room visits will be recorded. Higher number of emergency room visits indicates higher healthcare utilization.
measure: Change in Hospitalizations
time frame: Baseline, 4-months and additional 6-month follow-up
description: Number of hospitalizations will be recorded. Higher number of hospitalizations indicates higher healthcare utilization.
measure: Change in Institutionalization
time frame: Baseline, 4-months and additional 6-month follow-up
description: Institutionalization to long-term care will be recorded. Higher number individuals entering long-term care indicates higher healthcare utilization.
measure: Individual-level Economic Evaluation
time frame: Baseline, 4-months and additional 6-month follow-up
description: Individual-level economic evaluations will be assessed by changes in direct medical costs and effectiveness outcomes (e.g., quality-adjusted life years - QALYs), calculate and compare the incremental cost-effectiveness ratio (ICER) (e.g., $/ QALY gained, $/ a visit averted) against a willingness-to-pay threshold ($50,000/QALY) to show if this program of frailty rehabilitation represents good value for money.
arm group label: Arm1.Control
arm group type: Experimental
description: Participants randomized to the control arm will not receive any of the Frailty Rehabilitation Interventions. Participants in the control arm will receive Vitamin D.
arm group label: Arm2.Group Exercise
arm group type: Experimental
description: Participants will attend the exercise program, twice-weekly, for 4-months with supplemental home exercise.
arm group label: Arm3.Multi-modal Intervention
arm group type: Experimental
description: Group Exercise/Supplemental Home Exercise: This will be delivered identically to Arm 2.
Nutrition, protein supplementation, and a medication review will also be implemented.
intervention type: Other
intervention name: Control
description: Participants randomized to the control arm will not receive any of the Frailty Management Interventions.
arm group label: Arm1.Control
intervention type: Behavioral
intervention name: Group Exercise
description: A recent meta-analysis suggests 180 min/week of exercise (with a high challenge to balance) is most effective for fall prevention. Combined strength and endurance training performed at a moderate weekly frequency (i.e., two times per week) may promote marked gains on muscle hypertrophy, strength and power gains in frail older adults. Balance training is a key component of successful exercise programs for vulnerable older adults.
arm group label: Arm2.Group Exercise
arm group label: Arm3.Multi-modal Intervention
intervention type: Combination Product
intervention name: Nutrition and Medication review
description: Nutrition review: Conduct nutritional screening flow and review any questions, provide some additional counseling/coaching. Protein supplements will be provided to all participants unless contraindicated.
Medication review: Review/update current medication list and forward the list and medical history to the consultant study pharmacist.
arm group label: Arm3.Multi-modal Intervention
intervention type: Dietary Supplement
intervention name: Protein Supplement
description: Protein supplementation will be provided.
arm group label: Arm3.Multi-modal Intervention
intervention type: Dietary Supplement
intervention name: Vitamin D
description: 1000 IU of oral vitamin D
arm group label: Arm1.Control
arm group label: Arm2.Group Exercise
arm group label: Arm3.Multi-modal Intervention
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Alexandra Papaioannou, MD, MSc
role: Principal Investigator
affiliation: McMaster University
last name: Sherri Smith
phone: 905 521 2100
phone ext: 77715
email: smithsher@hhsc.ca
facility: 
status: Recruiting
contact: 
investigator: 
country: Canada
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responsible party type: Sponsor
mesh term: Frailty
mesh term: Vitamin D