Physical ActivityNCT01707121
The Impact of Physical Activity on the Outcome of Surgery
An observational study of Physical Activity and Breast Neoplasm, run by Sahlgrenska University Hospital at 2 sites in Sweden.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Activity, Breast Neoplasm, Colorectal Neoplasm
- How many people
- 450 participants
- Where
- 2 sitesSweden
- Study dates
- Dec 2012to Nov 2015
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients planned for a surgical procedure with a planned hospital stay of at least 1 day.
Who may be able to join
- All patients at including hospitals scheduled for any of the following procedures will be asked to participate: cholecystectomy, breast cancer surgery, colorectal cancer surgery
Who cannot join
- Inability to give informed consent.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Sahlgrenska University Hospital/Östra
Gothenburg, 416 85
Skövde Kärnsjukhus
Skövde
About this study
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.
Read the detailed description
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.
- Mostly sedentary
- Light PA (such as gardening or walking or bicycling to work) at least two hours a week
- Moderate PA such as aerobics, dancing, swimming, playing football or heavy gardening) at least two hours a week
- 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
- Conditions
- Physical Activity, Breast Neoplasm, Colorectal Neoplasm, Gall Stones
- Keywords
- morbidity, sick-leave, hospital stay
- Medical subject headings
- Motor Activity, Breast Neoplasms, Colorectal Neoplasms, Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Surgical patients | Patients with planned surgery for breast cancer, colorectal cancer and gall bladder disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of sick-leave/time to work
for breast cancer and gallbladder surgery
Measured: 6 weeks
Length of hospital stay
for colorectal surgery
Measured: 6 weekw
Secondary outcomes (4)
length of sick leave/time to work
for colon and rectal cancer: length of sick leave/time to work
Measured: 12 weeks
length of hospital stay
cholecystectomy and breast cancer: length of hospital stay
Measured: 6 weeks
Recovery
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.
Measured: 6 weeks
Health economic analysis
Health economic analysis of resource consumption
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startDec 2012
- Primary completionSep 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Angenete, Sahlgrenska University Hospital
- Investigators
- Eva Angenete, M.D., Ph.D., Principal investigator, SSORG, Scandinavian Surgical Outcomes Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01707121
- Sponsor's protocol ID
- Physsurg
- Status last verified
- Nov 2015
- First submitted
- 11 Oct 2012
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Nilsson H, Angeras U, Bock D, Borjesson M, Onerup A, Fagevik Olsen M, Gellerstedt M, Haglind E, Angenete E. Is preoperative physical activity related to post-surgery recovery? A cohort study of patients with breast cancer. BMJ Open. 2016 Jan 14;6(1):e007997. doi: 10.1136/bmjopen-2015-007997.
PubMed 26769776
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Physical Activity on the Outcome of Surgery
- ClinicalTrials.gov ID
- NCT01707121
- Acronym / sponsor ID
- Physsurg
- Conditions
- Physical Activity, Breast Neoplasm, Colorectal Neoplasm, Gall Stones
- Keywords
- morbidity, sick-leave, hospital stay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 16 Oct 2012 (estimated)
- 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.
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.
Detailed description
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.
- Mostly sedentary
- Light PA (such as gardening or walking or bicycling to work) at least two hours a week
- Moderate PA such as aerobics, dancing, swimming, playing football or heavy gardening) at least two hours a week
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical patients | – | –Patients with planned surgery for breast cancer, colorectal cancer and gall bladder disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients planned for a surgical procedure with a planned hospital stay of at least 1 day.
Key inclusion criteria (1 listed)
- All patients at including hospitals scheduled for any of the following procedures will be asked to participate: cholecystectomy, breast cancer surgery, colorectal cancer surgery
Key exclusion criteria (1 listed)
- Inability to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Length of sick-leave/time to work
Time frame: 6 weeks
for breast cancer and gallbladder surgery
Length of hospital stay
Time frame: 6 weekw
for colorectal surgery
4 secondary outcomes
length of sick leave/time to work
Time frame: 12 weeks
length of hospital stay
Time frame: 6 weeks
Recovery
Time frame: 6 weeks
Health economic analysis
Time frame: 12 months
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 20 Nov 2015.
- Derived from this study: PubMed 26769776Nilsson H, Angeras U, Bock D, Borjesson M, Onerup A, Fagevik Olsen M, Gellerstedt M, Haglind E, Angenete E. Is preoperative physical activity related to post-surgery recovery? A cohort study of patients with breast cancer. BMJ Open. 2016 Jan 14;6(1):e007997. doi: 10.1136/bmjopen-2015-007997.
- SSORG - Scandinavian Surgical Outcomes Research GroupLink provided by the sponsor.
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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.
Eva Angenete, M.D., Ph.D. principal investigator
SSORG, Scandinavian Surgical Outcomes Research Group
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Activity and Breast Neoplasm, run by Sahlgrenska University Hospital at 2 sites in Sweden.
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 1 inclusion and 1 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 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
Length of sick-leave/time to work (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 NCT01707121, which also lists 1 linked publication.
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 20 Nov 2015.