Physical Activity in Relation to Surgical Procedures

NCT ID: NCT02299596

Last Updated: 2023-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

761 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2025-12-31

Brief Summary

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This study will compare the outcome after surgery between a group of patients that receives instructions for prehabilitation training and one group that received standard treatment.

Detailed Description

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The aim of this study is to investigate whether a training program with intensified physical activity prior to and after a surgical procedure reduces the surgical-related postoperative recovery time, hospital stay, sick leave and complication rate.

A secondary aim is to investigate the effect of a training program with pre- and post- operative PA on the rate of resumption of QoL and normal physical function.

Conditions

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Colorectal Cancer Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Pre and postoperative exercise

The intervention is prehabilitation preoperatively and physical training postoperatively. During the hospital stay both groups will be treated in the same manner.

Preoperative intervention:

One half hour of exercise daily added to the existing daily exercise routine. The level of exercise should produce shortness of breath but the patient should be able to talk without much effort.

Inspiratory muscle training. Thirty breaths x two twice daily. Postoperative intervention is mainly the same as preoperatively.

Group Type EXPERIMENTAL

Physical activity

Intervention Type OTHER

The intervention will take place both pre- and postoperatively. During the hospital stay both groups will be treated in the same manner.

Control

Standard treatment with one exception, patients will fill in a physical activity diary

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Physical activity

The intervention will take place both pre- and postoperatively. During the hospital stay both groups will be treated in the same manner.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosed colorectal cancer and a planned surgical procedure

Exclusion Criteria

* HIPEC surgery, not able to give informed consent or understand the intervention
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Eva Haglind, MD, PhD, professor

Consultant Surgeon, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eva Haglind, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

SSORG

Locations

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Sahlgrenska University Hospital/Östra

Gothenburg, , Sweden

Site Status

Dept. of Surgery, Skaraborgs Sjukhus

Skövde, , Sweden

Site Status

Countries

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Sweden

References

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Onerup A, Li Y, Afshari K, Angenete E, de la Croix H, Ehrencrona C, Wedin A, Haglind E. Long-term results of a short-term home-based pre- and postoperative exercise intervention on physical recovery after colorectal cancer surgery (PHYSSURG-C): a randomized clinical trial. Colorectal Dis. 2024 Mar;26(3):545-553. doi: 10.1111/codi.16860. Epub 2024 Jan 15.

Reference Type DERIVED
PMID: 38225857 (View on PubMed)

Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub3.

Reference Type DERIVED
PMID: 37162250 (View on PubMed)

Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2022 May 19;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub2.

Reference Type DERIVED
PMID: 35588252 (View on PubMed)

Onerup A, Thorn SE, Angenete E, Bock D, Gryback Gillheimer E, Haglind E, Nilsson H. Effects of a home-based exercise program on the insulin-like growth factor axis in patients operated for colorectal cancer in Sweden: Results from the randomised controlled trial PHYSSURG-C. Growth Horm IGF Res. 2020 Apr;51:27-33. doi: 10.1016/j.ghir.2020.01.005. Epub 2020 Jan 28.

Reference Type DERIVED
PMID: 32007834 (View on PubMed)

Onerup A, Angenete E, Bock D, Borjesson M, Fagevik Olsen M, Gryback Gillheimer E, Skullman S, Thorn SE, Haglind E, Nilsson H. The effect of pre- and post-operative physical activity on recovery after colorectal cancer surgery (PHYSSURG-C): study protocol for a randomised controlled trial. Trials. 2017 May 8;18(1):212. doi: 10.1186/s13063-017-1949-9.

Reference Type DERIVED
PMID: 28482864 (View on PubMed)

Other Identifiers

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Physsurg C - the RCT

Identifier Type: -

Identifier Source: org_study_id