An interventional study of Exercise in Obesity, Morbid and Bariatric Surgery Candidate, sponsored by Universidad de Almeria. Completed at 1 site in Spain. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-09-07.
Sponsored by Universidad de Almeria · Not applicable, Interventional, and Treatment
Among 37 studies in Obesity, Morbid with a site in Spain — 10 open to participants now, 13 under way, none of them phase 3. Obesity, Morbid · Spain.
Among the 37 studies in Obesity, Morbid with a site in Spain, this one is the 10th largest by enrollment of the 24 interventional ones that give a count, is one of 2 that started in 2018, is one of 22 with no phase, and was the 17th registered.
941 studies on the registry are indexed under Obesity, Morbid; 163 are open to participants now.
Browse Obesity, Morbid studies →10 of the 37 studies in Obesity, Morbid with a site in Spain are open now. Recruiting first, the newest first:
Hospitales Universitarios Virgen del Rocío · Sites in Spain
University of Alicante · Sites in Spain
Instituto de Investigacion Sanitaria La Fe · Sites in Spain
Corporacion Parc Tauli · Sites in Spain
Institut de Recerca Biomèdica de Lleida · Sites in Spain
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 109 Obesity, Morbid studies recruiting now, 21 (19%) set no upper age limit and 83 (76%) stop at 75 or younger; 8 take children under 18; 9 take healthy volunteers.
This study: 18 Years to 60 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
37 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 2 started in 2018.
This study's enrollment of 80 is above the median of 62 across 602 interventional studies indexed under Obesity, Morbid.
Median enrollment 70 across the 24 interventional studies, 145 across the 13 observational. Of the 16 that completed or were terminated, 1 (6%) have results posted.
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3 of 37 have an industry lead sponsor. The 10 most frequent:
Universidad de Almeria is the lead sponsor of 72 studies on the registry; 11 are open to participants now.
Universidad de Almeria has 1 study filed under Obesity, Morbid — fewer than ten, so there is no comparison to draw.
1 of the studies in Obesity, Morbid with a site in Spain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06226194Institut de Recerca Biomèdica de LleidaGenetic Susceptibility to Predict Weight Loss After Bariatric Surgery | 2027-03-15 |
Among the 37 studies in Obesity, Morbid with a site in Spain, from their registry updates:
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Severe/morbid obesity is an international public health issue that importantly increases the risk of cardiovascular events and cardiovascular and all-cause mortality. Likewise, severe/morbid obesity increases the risk of illness, reduces quality of life, and raises health-care costs. Bariatric surgery is the election method for the treatment of severe/morbid obesity, resulting in significant weight loss and remission of comorbidities. However, a relatively large proportion of bariatric patients regain weight and continue to be at high risk for cardiovascular disease and premature mortality. A healthy lifestyle following bariatric surgery is essential for optimizing and maintaining weight loss. Observational studies suggest that physical activity following bariatric surgery might be associated with additional weight loss and more effective weigh loss maintenance over time. However, very little experimental evidence exists regarding the effects of supervised exercise on obesity-related outcomes in this specific population.
The aim of the EFIBAR (Ejercicio FÍsico tras cirugía BARiátrica) randomized controlled trial is to determine the effects of a 16-week supervised concurrent (aerobic and strength) exercise intervention program, on weight loss (primary outcome), body composition, cardiometabolic risk, physical fitness and quality of life (secondary outcomes) in patients with severe/morbid obesity following bariatric surgery.
According to the study aims the investigators pursue the following hypothesis: Supervised exercise will result in larger weight loss than control.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
To comply with local bariatric surgery criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Usual care PLUS concurrent (aerobic and strength) supervised exercise program of 16 weeks (3 sessions/week, 60 min/session, progressively increasing in volume and intensity). The program will be conducted by certified Exercise Science professionals.
Other: Exercise
Usual care routinely delivered after bariatric surgery, based on national (Spanish) and international recommendations, focused on nutritional status monitoring and diet/physical activity counseling.
Concurrent (aerobic and strength) supervised exercise program: the program comprises 3 sessions/week (60 min/session) of aerobic and strength exercises of progressive volume and intensity. The program will follow the Consensus on Exercise Reporting Template (CERT) guidelines.
Also known as: Exercise training
Percent total weight loss (%TWL) [Biospace Co., InBody 270, USA]
%TWL = \[(pre-surgery weight - post-surgery weight) / (pre-surgery weight)\] x 100
Time frame: Changes from baseline to 4-month and 1-year follow-up
Body composition: body fat
Percent body fat (%) assessed by bioimpedance analysis (InBody 270, Biospace Co., USA)
Time frame: Changes from baseline to 4-month and 1-year follow-up
Body composition: fat-free mass
Fat-free mass (kg) assessed by bioimpedance analysis (InBody 270, Biospace Co., USA)
Time frame: Changes from baseline to 4-month and 1-year follow-up
Body composition: fat-free mass index
Fat-free mass index (kg/m2) assessed by bioimpedance analysis (InBody 270, Biospace Co., USA)
Time frame: Changes from baseline to 4-month and 1-year follow-up
Body composition: central body fat
Waist and hip circumferences (measured in cm with an anthropometric tape), waist / height ratio
Time frame: Changes from baseline to 4-month and 1-year follow-up
Lipid profile assessed from blood sample
Total cholesterol (mg/dl), HDL-cholesterol (mg/dl), LDL-cholesterol (mg/dl) and triglycerides (mg/dl)
Time frame: Changes from baseline to 4-month and 1-year follow-up
Blood markers of glucose metabolism: glucose
Glucose (mg/dL)
Time frame: Changes from baseline to 4-month and 1-year follow-up
Blood markers of glucose metabolism: insulin
Insulin (μUI/mL)
Time frame: Changes from baseline to 4-month and 1-year follow-up
Blood markers of glucose metabolism: HOMA-IR
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: Changes from baseline to 4-month and 1-year follow-up
Blood markers of glucose metabolism: glycated hemoglobin HbA1c
Glycated hemoglobin HbA1c (%)
Time frame: Changes from baseline to 4-month and 1-year follow-up
Brachial and central blood pressures (mmHg)
Systolic and diastolic blood pressures assessed by Mobil-O-Graph
Time frame: Changes from baseline to 4-month and 1-year follow-up
Arterial stiffness
Pulse wave velocity (PWV, m/s) by Mobil-O-Graph
Time frame: Changes from baseline to 4-month and 1-year follow-up
Plasma concentrations of inflammatory markers
High-sensitivity C-reactive protein (hs-CRP)
Time frame: Changes from baseline to 4-month and 1-year follow-up
Plasma concentrations of inflammatory markers
Tumor necrosis factor (TNF-alpha)
Time frame: Changes from baseline to 4-month and 1-year follow-up
Plasma concentrations of inflammatory markers
Interleukin 6 (IL-6)
Time frame: Changes from baseline to 4-month and 1-year follow-up
Plasma concentrations of liver metabolism enzymes
GGT (gamma-glutamyltransferase)
Time frame: Changes from baseline to 4-month and 1-year follow-up
Plasma concentrations of liver metabolism enzymes
GPT (glutamate-pyruvate transaminase)
Time frame: Changes from baseline to 4-month and 1-year follow-up
Plasma concentrations of liver metabolism enzymes
GOT (glutamate-oxalacetate transaminase)
Time frame: Changes from baseline to 4-month and 1-year follow-up
Plasma levels of Vitamin D
Concentrations of 25-hydroxyvitamin D (ng/mL)
Time frame: Changes from baseline to 4-month and 1-year follow-up
Heart rate variability (HRV)
Assessed by heart rate monitor (Polar V800)
Time frame: Changes from baseline to 4-month and 1-year follow-up
Health-related physical fitness: cardiorespiratory fitness
Cardiorespiratory fitness, assessed using a maximal treadmill test
Time frame: Changes from baseline to 4-month and and 1-year follow-up
Health-related physical fitness: upper body muscular strength
Upper body muscular strength, assessed using handgrip dynamometry (kg)
Time frame: Changes from baseline to 4-month and and 1-year follow-up
Health-related physical fitness: lower body muscular strength
Lower body muscular strength, assessed using the 30-seconds chair-stand test (number of repetitions)
Time frame: Changes from baseline to 4-month and and 1-year follow-up
Health-related physical fitness: upper body flexibility
Upper body flexibility, assessed using the back scratch test (cm)
Time frame: Changes from baseline to 4-month and and 1-year follow-up
Objectively-measured physical activity
Assessed by accelerometry (ActiGraph, software ActiLife)
Time frame: Changes from baseline to 4-month and 1-year follow-up
Health-Related Quality of Life (HRQoL): SF-36
Measured by the 36-item Short Form Health Survey (SF-36)
Time frame: Changes from baseline to 4-month and 1-year follow-up
Health-Related Quality of Life (HRQoL): EQ-5D-3L
Measured by European Quality of Life - 5 Dimensions-3Levels (EQ-5D-3L)
Time frame: Changes from baseline to 4-month and 1-year follow-up
Symptomatology and function of hip / knee osteoarthritis: Pain
Measured by the WOMAC (Western Ontario and McMaster Universities) Osteoarthritis Index. The PAIN scale within the WOMAC questionnaire contains 5 items, each one scoring from 0 (Nothing) to 4 (Very much), what makes a total score ranging from 0 (better) to 20 (worse).
Time frame: Changes from baseline to 4-month and 1-year follow-up
Symptomatology and function of hip / knee osteoarthritis: Function
Measured by the WOMAC (Western Ontario and McMaster Universities) Osteoarthritis Index. The FUNCTION scale within the WOMAC questionnaire contains 17 items, each one scoring from 0 (No trouble) to 4 (Very much difficult), what makes a total score ranging from 0 (better) to 68 (worse).
Time frame: Changes from baseline to 4-month and 1-year follow-up
Symptomatology and function of hip / knee osteoarthritis: Stiffness
Measured by the WOMAC (Western Ontario and McMaster Universities) Osteoarthritis Index. The STIFFNESS scale within the WOMAC questionnaire contains 2 items, each one scoring from 0 (Nothing) to 4 (Very much), what makes a total score ranging from 0 (better) to 8 (worse).
Time frame: Changes from baseline to 4-month and 1-year follow-up
Depression, anxiety and stress
Measured by the Depression, Anxiety and Stress Scale short form (DASS-21). The DASS-21 comprises three sub-scales assessing specific psychiatric symptoms (i.e., depression, anxiety, and stress). Each of these symptoms is assessed using seven items rated on a 4-point Likert-type scale (i.e., 0 = ''Did not apply to me at all''; 3 = ''Applied to me very much, or most of the time''). Summed score for each psychiatric symptom ranges from 0 to 21. Higher scores in each sub-scale indicate higher levels of depressive, anxiety or stress symptomatology. According to the specific nature of the three psychiatric symptoms assessed by the DASS-21, these are treated independently so that no total score is available.
Time frame: Changes from baseline to 4-month and 1-year follow-up
Emotional, psychological and social well-being
Measured by the Mental Health Continuum-Short Form (MHC-SF)
Time frame: Changes from baseline to 4-month and 1-year follow-up
Cost-effectiveness analysis (CEA)
The costs will consider those related to the surgery, the exercise program, prescription medication, sick leave, post-surgery complications and readmission rates, time and effort requiring each treatment, as well as possible dietary and informal care costs. Effectiveness will be considered as changes observed in the main clinical outcomes: weight loss and cardiometabolic risk (remission/relapse of hypertension, dyslipidemia and type 2 diabetes).
Time frame: From baseline to 1-year follow-up
Cost-utility analysis (CUA)
The costs will consider those related to the surgery, the exercise program, prescription medication, sick leave, post-surgery complications and readmission rates, time and effort requiring each treatment, as well as possible dietary and informal care costs. Utility will evaluate variation in quality of life experienced by participants, computed as changes in quality-adjusted life years (QALY) using SF-36 questionnaire.
Time frame: From baseline to 1-year follow-up
Cost-utility analysis (CUA)
The costs will consider those related to the surgery, the exercise program, prescription medication, sick leave, post-surgery complications and readmission rates, time and effort requiring each treatment, as well as possible dietary and informal care costs. Utility will evaluate variation in quality of life experienced by participants, computed as changes in quality-adjusted life years (QALY) using EQ-5D-3L questionnaire.
Time frame: From baseline to 1-year follow-up
Plan to share: Yes — All IPD will be shared once the study is finalised and the main results are published. IPD can be obtained by contacting the responsible party (artero@ual.es).
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Two years (24 months) after the study completion.
Access criteria: The PI must be contacted and a minimum number of co-authors from the research team must be included in any publication.
Ran from May 2018 to primary completion in Sep 2022, 52 months.
Of 274 non-industry interventional studies with no phase under Obesity, Morbid, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 48. This study's 52 months is above that.
Counting every sponsor, half of 286 studies reached it within 25 months; a quarter within 11 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Universidad de Almeria