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Completed

NCT Number: NCT03641027

Physical Activity Before Obesity Surgery

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion Criterion:

  • Patients at including hospitals scheduled for gastric bypass surgery

Exclusion criteria

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

Treatment and study plan

Increased physical activity

Other

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

Other

Primary outcomes

  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 outcomes

  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- glucose metabolism

    Time frame: From surgery to 2 years postoperatively

    Glucose metabolism-

  5. Blood test- Blood lipids

    Time frame: From surgery to 2 years postoperatively

    Metabolic change lipids

  6. Blood tests, Blood sugar

    Time frame: From surgery to 2 years postoperatively

    HbA1c

  7. Blood tests, fasting blood suger

    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 medication because of co-morbidity

    Time frame: From inclusion 1 year postoperatively

    Number of patients with medication because of diabetes, high blood pressure and dyslipidemia.

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Borås Lasarett
  • Centrallasarettet i Växjö
  • Karlshamns lasarett
  • Mora sjukhus
  • Torsby sjukhus

Registry information

Acronym: PABOS

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Aug 21, 2018
Registry last updated
Mar 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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