Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Physical Activity Before Obesity Surgery (PABOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03641027
Recruitment Status : Recruiting
First Posted : August 21, 2018
Last Update Posted : April 24, 2019
Sponsor:
Collaborators:
Borås Lasarett
Centrallasarettet i Växjö
Karlshamns lasarett
Torsby sjukhus
Mora sjukhus
Information provided by (Responsible Party):
Göteborg University

Brief Summary:

There are limited knowledge about the impact of increased pre-operative physical training on postoperative physical activity levels as well as on recovery and complication rates after bariatric surgery.

The primary aim of this study is to investigate whether an intervention including individual coaching to improve level of physical activity before and after gastric bypass surgery leads to a changed of level physical activity post-operatively at eight weeks, one and two years.

Secondary aims of the study are to investigate whether increased physical activity has effects on complication rates, re-admissions and re-operations, post-operative weight-loss, gastrointestinal pain, recovery measured as hospital stay, sick-leave and QoL, resumption of normal physical activity.

METHODS 300 patients will be recruited and randomized to an intervention group or control group. The patients in the intervention group will receive individual coaching by a physical therapist to:

  • increase physical activity 30 minutes/day (At least 150 min/week)
  • decrease time spent sitting/lying The patients in the control group will receive standard care.

Before surgery, 6 weeks, and one year after surgery patient will fill in a questionnaire including level of physical activity, sick leave, quality of life and gastrointestinal pain. In addition blood test will be taken and complication rates recorded.


Condition or disease Intervention/treatment Phase
Obesity Physical Activity Other: Increased physical activity Other: Standard care Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment A single blind, randomized, controlled, intervention study. Evaluation of the addition of increased physical activity for patients undergoing obesity surgery compared to standard care.
Masking: Single (Outcomes Assessor)
Masking Description: Assessor will not be aware of which group the patients are included in.
Primary Purpose: Treatment
Official Title: Physical Activity Before Obesity Surgery
Actual Study Start Date : February 16, 2016
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Increased physical activity
Increased physical activity daily before surgery. Standard care during hospital stay and continued training after discharge.
Other: Increased physical activity

Preoperatively

Individual coaching by a physical therapist to:

  • increase physical activity 30 minutes/day (At least 150 min/week)
  • decrease time spent sitting/lying

Telephone follow up one week after the intervention starts

At the hospital

-Frequent mobilization

After discharge

A telephone follow up one week postoperatively with coaching by a physical therapist to:

  • increase physical activity 30 minutes/day (At least 150 min/week) until 8 weeks postoperatively
  • decrease time spent sitting/lying

The intervention includes a prescribed FaR (Fysisk aktivitet på recept) with frequency, duration and intensity of the activity corresponding 12-15 on the BORG-RPE scale.


Standard care
Standard care
Other: Standard care



Primary Outcome Measures :
  1. INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRES (IPAQ) [ Time Frame: From inclusion 1 year postoperatively ]
    Physical activity level measured in METS (Metabolic Equivalent)

  2. Saltin-Grimby Physical Activity Scale (SGPAS) [ Time Frame: From inclusion to 1 year postoperatively ]
    Physical activity level, 1-4 (4 highest activity level).


Secondary Outcome Measures :
  1. Complication rates [ Time Frame: From inclusion to 30 days postoperatively ]
    Anastomotic leakages, bleedings that require intervention, thrombosis, re-admissions and re-operations derived from the patient medical records

  2. Length of stay [ Time Frame: From surgery to discharge. On average two days ]
    Days at hospital

  3. Sick-leave [ Time Frame: From surgery to at latest 1 year postoperatively ]
    Sick-leave is prescribed one week at a time, patients are required to call the doctor, to ask for prolonged sick-leave a week at a time.

  4. Blood test [ Time Frame: From surgery to 2 years postoperatively ]
    Glucose metabolism.

  5. Blood test [ Time Frame: From surgery to 2 years postoperatively ]
    Metabolic change lipids

  6. Blood tests [ Time Frame: From surgery to 2 years postoperatively ]
    HbA1c

  7. Blood tests [ Time Frame: From surgery to 2 years postoperatively ]
    Fasting P-glucose

  8. Blood tests [ Time Frame: From surgery to 2 years postoperatively ]
    Blood lipids

  9. Weight [ Time Frame: From surgery to 2 years postoperatively ]
    Actual weight measured during clinical visits

  10. General Quality of Life, QoL By EQ5D [ Time Frame: From inclusion 1 year postoperatively ]
    EQ5D, 5 questions with 3 different answers each (1 best value) leaving a 5 digit code which is transfered to a score from 0.3403-0.9694

  11. Gastrointestinal pain by Gastrointestinal Symptom Rating Scale (GSRS) [ Time Frame: From inclusion 1 year postoperatively ]
    Gastrointestinal Symptom Rating Scale, 16 questions rated on scales with 7 levels (a-low symptoms to g- worst symtoms)

  12. Self reported co-morbidity [ Time Frame: From inclusion 1 year postoperatively ]
    Number of patients with diabetes and with dyslipidemia medications

  13. Self reported co-morbidity [ Time Frame: From inclusion 1 year postoperatively ]
    Number of patients with medication because of diabetes, high blood pressure and dyslipidemia.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criterion:

• All patients at including hospitals scheduled for gastric bypass surgery

Exclusion Criteria:

  • Inability to understand given information.
  • Inability to perform the intervention

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03641027


Contacts
Layout table for location contacts
Contact: Monika Fagevik Olsén, PhD +46 31 342 11 95 monika.fagevik-olsen@vgregion.se

Locations
Layout table for location information
Sweden
Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden, 413 45
Contact: Monika Fagevik Olsén, PhD    +46 31 342 11 95    monika.fagevik-olsen@vgregion.se   
Sponsors and Collaborators
Göteborg University
Borås Lasarett
Centrallasarettet i Växjö
Karlshamns lasarett
Torsby sjukhus
Mora sjukhus
Investigators
Layout table for investigator information
Principal Investigator: Monika Fagevik Olsén, pHd Sahlgrenska Academy at Gothenburg university, Sweden

Layout table for additonal information
Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT03641027     History of Changes
Other Study ID Numbers: FoU i VGR: 202291
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Göteborg University:
Obesity
Physical Activity
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms