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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Sweden

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.

  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
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 groups in NCT01707121
Study groupRoleWhat they receive
Surgical patientsPatients 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.

  1. Length of sick-leave/time to work

    for breast cancer and gallbladder surgery

    Measured: 6 weeks

  2. Length of hospital stay

    for colorectal surgery

    Measured: 6 weekw

Secondary outcomes (4)
  1. length of sick leave/time to work

    for colon and rectal cancer: length of sick leave/time to work

    Measured: 12 weeks

  2. length of hospital stay

    cholecystectomy and breast cancer: length of hospital stay

    Measured: 6 weeks

  3. 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

  4. 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.

  1. First posted16 Oct 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionSep 2015
  4. Study completionNov 2015

Resources

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)
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

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.

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