<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/NCT01707121</url>
  </required_header>
  <id_info>
    <org_study_id>Physsurg</org_study_id>
    <nct_id>NCT01707121</nct_id>
  </id_info>
  <brief_title>The Impact of Physical Activity on the Outcome of Surgery</brief_title>
  <official_title>The Impact of Physical Activity on the Outcome of Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sahlgrenska University Hospital, Sweden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sahlgrenska University Hospital, Sweden</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Over the last decades different life style factors have been established as risk factors for&#xD;
      various diseases. The obesity pandemic displays a good example of a disease where great&#xD;
      effort is undertaken to characterize risk factors associated with obesity (1). Smoking is&#xD;
      another life style risk factor established since several decades, and where primary&#xD;
      prevention has been increasingly successful (2, 3). Cardiovascular epidemiologic research at&#xD;
      the University of Gothenburg recognized PA as a factor of importance early on and thus&#xD;
      included PA related questions in the work up of studies with large cohorts (4-6). A 4-level&#xD;
      scale was introduced in the late 1960:s by Saltin and Grimby (7) and has been used&#xD;
      extensively since then. With this background it is of interest to record physical activity&#xD;
      one year and one month prior to certain types of elective surgery and to study the&#xD;
      relationship of PA to surgical complications and recovery is of interest.&#xD;
&#xD;
      The aim of this study is to investigate whether a higher physical activity prior to a&#xD;
      surgical procedure reduces hospital stay, sick leave and the complication rate.&#xD;
&#xD;
      A secondary aim is to investigate the effect of preoperative physical activity on the rate of&#xD;
      resumption of QoL and normal physical function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Physical activity (PA) has been in focus over the last two decades as a life style factor of&#xD;
      importance. A review summarizing nearly 170 studies states that the scientific evidence for&#xD;
      the association between lack of physical activity and cancer is convincing regarding breast&#xD;
      and colon cancer and probable for prostate cancer and possible for lung and endometrial&#xD;
      cancer (8). Regarding postoperative rehabilitation the benefits from preoperative physical&#xD;
      exercise together with a postoperative early rehabilitation schedule has been reported for&#xD;
      spinal surgery (9). In colorectal surgery the benefits of enhanced recovery programs have&#xD;
      been clearly demonstrated (10). The impact of preoperative prehabilitation has been evaluated&#xD;
      and seems beneficial (11, 12), however most studies have not used clinically important&#xD;
      outcome measures such as complications or postoperative morbidity. The evidence for&#xD;
      prehabilitation as a measure to reduce postoperative morbidity is scarce (12). To evaluate&#xD;
      the recovery after a surgical procedure in a broader sense is difficult. Several scales have&#xD;
      been tried to assess recovery (13-16).&#xD;
&#xD;
      The simple instrument for self-reported PA introduced by Saltin and Grimby has been shown to&#xD;
      discriminate between sedentary and active counterparts regarding maximum oxygen uptake (17)&#xD;
      and has been validated against biological measures (18). Indeed, studies have indicated that&#xD;
      such single self-reported approximation of the level of PA, may predict risk for morbidity&#xD;
      and cardiovascular as well as total mortality (19-21). The self-assessed PA-level concurs&#xD;
      well with the actual physical fitness of the individual (22-24). This is also important,&#xD;
      since cardiorespiratory fitness may also predict cardiovascular risk and mortality (25).&#xD;
&#xD;
      There are also studies indicating that other life-style factors such as alcohol consumption&#xD;
      has a negative impact on outcome after surgery as well as outcome after health-care&#xD;
      associated infections (26, 27). To screen for excessive alcohol consumption the Alcohol Use&#xD;
      Disorders Identification Test-Consumption (AUDIT) test has been used. Several recent studies&#xD;
      have indicated that a shorter survey with the top three questions in the AUDIT questionnaire&#xD;
      (AUDIT-C) is sufficient to provide information on alcohol use (28, 29).&#xD;
&#xD;
      Smoking is also a life-style factor that affects surgical outcome (30). It has been shown to&#xD;
      increase the risk for complications and studies indicate that smoking cessation prior to the&#xD;
      surgical procedure to reduce the risk for complications (31). Self-reported assessment of&#xD;
      smoking seems to be accurate and reflect the actual nicotine use of the individual (32).&#xD;
&#xD;
      Length of hospital stay is of importance both to patients and the society. A surgical&#xD;
      procedure that shortens hospital stay may be cost-effective even in cases with higher&#xD;
      operation room costs (33). It is also of importance to consider time to work/sick leave; a&#xD;
      cost for patients and society that can affect the cost analysis of a surgical procedure (34).&#xD;
&#xD;
      The aim of this study is to investigate whether a higher physical activity prior to a&#xD;
      surgical procedure reduces hospital stay, sick leave and the complication rate.&#xD;
&#xD;
      A secondary aim is to investigate the effect of preoperative physical activity on the rate of&#xD;
      resumption of QoL and normal physical function.&#xD;
&#xD;
      In order to explore the importance of PA for the outcome after a surgical procedure due to&#xD;
      gallbladder disease, breast cancer and colorectal cancer we will ask all patients operated&#xD;
      for any of the three above mentioned conditions to answer a short questionnaire (Appendix I)&#xD;
      including the Saltin and Grimby (7) questions to study of the effects of the level of PA&#xD;
      immediately before surgical operations. The patients will be asked to estimate their physical&#xD;
      activity four weeks prior to the surgical procedure.&#xD;
&#xD;
        1. Mostly sedentary&#xD;
&#xD;
        2. Light PA (such as gardening or walking or bicycling to work) at least two hours a week&#xD;
&#xD;
        3. Moderate PA such as aerobics, dancing, swimming, playing football or heavy gardening) at&#xD;
           least two hours a week&#xD;
&#xD;
        4. Vigorous PA (high intensity) at least five hours daily several times a week.&#xD;
&#xD;
      They will also be asked to report weight, length, smoking habits, alcohol consumption,&#xD;
      socioeconomic situation, diabetes, hypertension, hyperlipidaemia and BMI as well as certain&#xD;
      questions with relation to Quality of Life and their postoperative recovery (Appendix I). The&#xD;
      questions are to some extent validated through previous research (28, 29, 32, 47, 48) but&#xD;
      some questions are newly constructed. The new questions have been constructed by an expert&#xD;
      panel consisting of colorectal and general surgeons, cardiologist and specialized nurses. The&#xD;
      domains chosen have been related to previous research regarding recovery (42). The&#xD;
      questionnaire has been face-to face validated by patients with gall bladder surgery planned&#xD;
      or a previous cholecystectomy performed, patients with breast cancer both prior and after&#xD;
      surgery and colorectal cancer patients prior and after surgery using the same validation&#xD;
      methods previously described for prostate cancer (48).&#xD;
&#xD;
      All patients will be contacted by telephone and a subsequently receive a mailed questionnaire&#xD;
      (similar to the pre-operative questionnaire) (Appendix II) regarding their self-assessed QoL&#xD;
      post-operatively and postoperative recovery, the timing of this will be related to the&#xD;
      estimated time for recovery as follows:&#xD;
&#xD;
        -  3 weeks after gallbladder surgery&#xD;
&#xD;
        -  3 and 6 weeks after surgery for breast cancer&#xD;
&#xD;
        -  3 and 6 weeks after surgery for colorectal cancer&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Length of sick-leave/time to work</measure>
    <time_frame>6 weeks</time_frame>
    <description>for breast cancer and gallbladder surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>6 weekw</time_frame>
    <description>for colorectal surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>length of sick leave/time to work</measure>
    <time_frame>12 weeks</time_frame>
    <description>for colon and rectal cancer: length of sick leave/time to work</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length of hospital stay</measure>
    <time_frame>6 weeks</time_frame>
    <description>cholecystectomy and breast cancer: length of hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recovery</measure>
    <time_frame>6 weeks</time_frame>
    <description>Recovery measured as resumption of Quality of Life and return to normal function after surgery according to the patient's self-reported assessment in the postoperative questionnaire and measured as return to pre-operative levels.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health economic analysis</measure>
    <time_frame>12 months</time_frame>
    <description>Health economic analysis of resource consumption</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">450</enrollment>
  <condition>Physical Activity</condition>
  <condition>Breast Neoplasm</condition>
  <condition>Colorectal Neoplasm</condition>
  <condition>Gall Stones</condition>
  <arm_group>
    <arm_group_label>Surgical patients</arm_group_label>
    <description>Patients with planned surgery for breast cancer, colorectal cancer and gall bladder disease</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients planned for a surgical procedure with a planned hospital stay of at least 1 day.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients at including hospitals scheduled for any of the following procedures will&#xD;
             be asked to participate: cholecystectomy, breast cancer surgery, colorectal cancer&#xD;
             surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to give informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eva Angenete, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>SSORG, Scandinavian Surgical Outcomes Research Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sahlgrenska University Hospital/Östra</name>
      <address>
        <city>Göteborg</city>
        <zip>416 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skövde Kärnsjukhus</name>
      <address>
        <city>Skövde</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <link>
    <url>http://www.ssorg.net</url>
    <description>SSORG - Scandinavian Surgical Outcomes Research Group</description>
  </link>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>November 18, 2015</last_update_submitted>
  <last_update_submitted_qc>November 18, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sahlgrenska University Hospital, Sweden</investigator_affiliation>
    <investigator_full_name>Eva Angenete</investigator_full_name>
    <investigator_title>Consultant surgeon, M.D., Ph.D.</investigator_title>
  </responsible_party>
  <keyword>morbidity</keyword>
  <keyword>sick-leave</keyword>
  <keyword>hospital stay</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Gallstones</mesh_term>
  </condition_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/NCT01707121
org study id: Physsurg
nct id: NCT01707121
lead sponsor: 
has dmc: No
Over the last decades different life style factors have been established as risk factors for
      various diseases. The obesity pandemic displays a good example of a disease where great
      effort is undertaken to characterize risk factors associated with obesity (1). Smoking is
      another life style risk factor established since several decades, and where primary
      prevention has been increasingly successful (2, 3). Cardiovascular epidemiologic research at
      the University of Gothenburg recognized PA as a factor of importance early on and thus
      included PA related questions in the work up of studies with large cohorts (4-6). A 4-level
      scale was introduced in the late 1960:s by Saltin and Grimby (7) and has been used
      extensively since then. With this background it is of interest to record physical activity
      one year and one month prior to certain types of elective surgery and to study the
      relationship of PA to surgical complications and recovery is of interest.

      The aim of this study is to investigate whether a higher physical activity prior to a
      surgical procedure reduces hospital stay, sick leave and the complication rate.

      A secondary aim is to investigate the effect of preoperative physical activity on the rate of
      resumption of QoL and normal physical function.
Physical activity (PA) has been in focus over the last two decades as a life style factor of
      importance. A review summarizing nearly 170 studies states that the scientific evidence for
      the association between lack of physical activity and cancer is convincing regarding breast
      and colon cancer and probable for prostate cancer and possible for lung and endometrial
      cancer (8). Regarding postoperative rehabilitation the benefits from preoperative physical
      exercise together with a postoperative early rehabilitation schedule has been reported for
      spinal surgery (9). In colorectal surgery the benefits of enhanced recovery programs have
      been clearly demonstrated (10). The impact of preoperative prehabilitation has been evaluated
      and seems beneficial (11, 12), however most studies have not used clinically important
      outcome measures such as complications or postoperative morbidity. The evidence for
      prehabilitation as a measure to reduce postoperative morbidity is scarce (12). To evaluate
      the recovery after a surgical procedure in a broader sense is difficult. Several scales have
      been tried to assess recovery (13-16).

      The simple instrument for self-reported PA introduced by Saltin and Grimby has been shown to
      discriminate between sedentary and active counterparts regarding maximum oxygen uptake (17)
      and has been validated against biological measures (18). Indeed, studies have indicated that
      such single self-reported approximation of the level of PA, may predict risk for morbidity
      and cardiovascular as well as total mortality (19-21). The self-assessed PA-level concurs
      well with the actual physical fitness of the individual (22-24). This is also important,
      since cardiorespiratory fitness may also predict cardiovascular risk and mortality (25).

      There are also studies indicating that other life-style factors such as alcohol consumption
      has a negative impact on outcome after surgery as well as outcome after health-care
      associated infections (26, 27). To screen for excessive alcohol consumption the Alcohol Use
      Disorders Identification Test-Consumption (AUDIT) test has been used. Several recent studies
      have indicated that a shorter survey with the top three questions in the AUDIT questionnaire
      (AUDIT-C) is sufficient to provide information on alcohol use (28, 29).

      Smoking is also a life-style factor that affects surgical outcome (30). It has been shown to
      increase the risk for complications and studies indicate that smoking cessation prior to the
      surgical procedure to reduce the risk for complications (31). Self-reported assessment of
      smoking seems to be accurate and reflect the actual nicotine use of the individual (32).

      Length of hospital stay is of importance both to patients and the society. A surgical
      procedure that shortens hospital stay may be cost-effective even in cases with higher
      operation room costs (33). It is also of importance to consider time to work/sick leave; a
      cost for patients and society that can affect the cost analysis of a surgical procedure (34).

      The aim of this study is to investigate whether a higher physical activity prior to a
      surgical procedure reduces hospital stay, sick leave and the complication rate.

      A secondary aim is to investigate the effect of preoperative physical activity on the rate of
      resumption of QoL and normal physical function.

      In order to explore the importance of PA for the outcome after a surgical procedure due to
      gallbladder disease, breast cancer and colorectal cancer we will ask all patients operated
      for any of the three above mentioned conditions to answer a short questionnaire (Appendix I)
      including the Saltin and Grimby (7) questions to study of the effects of the level of PA
      immediately before surgical operations. The patients will be asked to estimate their physical
      activity four weeks prior to the surgical procedure.

        1. Mostly sedentary

        2. Light PA (such as gardening or walking or bicycling to work) at least two hours a week

        3. Moderate PA such as aerobics, dancing, swimming, playing football or heavy gardening) at
           least two hours a week

        4. Vigorous PA (high intensity) at least five hours daily several times a week.

      They will also be asked to report weight, length, smoking habits, alcohol consumption,
      socioeconomic situation, diabetes, hypertension, hyperlipidaemia and BMI as well as certain
      questions with relation to Quality of Life and their postoperative recovery (Appendix I). The
      questions are to some extent validated through previous research (28, 29, 32, 47, 48) but
      some questions are newly constructed. The new questions have been constructed by an expert
      panel consisting of colorectal and general surgeons, cardiologist and specialized nurses. The
      domains chosen have been related to previous research regarding recovery (42). The
      questionnaire has been face-to face validated by patients with gall bladder surgery planned
      or a previous cholecystectomy performed, patients with breast cancer both prior and after
      surgery and colorectal cancer patients prior and after surgery using the same validation
      methods previously described for prostate cancer (48).

      All patients will be contacted by telephone and a subsequently receive a mailed questionnaire
      (similar to the pre-operative questionnaire) (Appendix II) regarding their self-assessed QoL
      post-operatively and postoperative recovery, the timing of this will be related to the
      estimated time for recovery as follows:

        -  3 weeks after gallbladder surgery

        -  3 and 6 weeks after surgery for breast cancer

        -  3 and 6 weeks after surgery for colorectal cancer
observational model: Cohort
time perspective: Prospective
measure: Length of sick-leave/time to work
time frame: 6 weeks
description: for breast cancer and gallbladder surgery
measure: Length of hospital stay
time frame: 6 weekw
description: for colorectal surgery
measure: length of sick leave/time to work
time frame: 12 weeks
description: for colon and rectal cancer: length of sick leave/time to work
measure: length of hospital stay
time frame: 6 weeks
description: cholecystectomy and breast cancer: length of hospital stay
measure: Recovery
time frame: 6 weeks
description: Recovery measured as resumption of Quality of Life and return to normal function after surgery according to the patient's self-reported assessment in the postoperative questionnaire and measured as return to pre-operative levels.
measure: Health economic analysis
time frame: 12 months
description: Health economic analysis of resource consumption
arm group label: Surgical patients
description: Patients with planned surgery for breast cancer, colorectal cancer and gall bladder disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eva Angenete, M.D., Ph.D.
role: Principal Investigator
affiliation: SSORG, Scandinavian Surgical Outcomes Research Group
facility: 
facility: 
country: Sweden
url: http://www.ssorg.net
description: SSORG - Scandinavian Surgical Outcomes Research Group
responsible party type: Principal Investigator
investigator affiliation: Sahlgrenska University Hospital, Sweden
investigator full name: Eva Angenete
investigator title: Consultant surgeon, M.D., Ph.D.
mesh term: Neoplasms
mesh term: Breast Neoplasms
mesh term: Colorectal Neoplasms
mesh term: Gallstones