NCT02843048

Brief Summary

Despite being effective in weight reduction in severely obese patients, bariatric surgery (BS) negatively influences bone metabolism and increases the risk of falls thereby potentially increasing the risk of fracture. The mechanisms of BS induced bone loss are unknown but may be related to calcium and vitamin D malabsorption, changes in the energy regulation metabolism and gastrointestinal hormonal physiology. Since the etiology of BS induced bone loss is largely unknown, treatment relies mostly on calcium and vitamin D supplementation, which provide little benefit. Exercise is an effective strategy to prevent bone mass losses in several health conditions. However, no study so far has examined the effects of an exercise-training program in the prevention of BS induced bone loss. The investigators main goal is to investigate the effects on bone metabolism and fracture risk of an exercise-training program specifically tailored to improve bone health and balance of patients that underwent BS. The investigators will perform a randomized controlled trial on obese patients (n=80; BMI\>40 Kg.m-2) elected to BS. Patients will be randomly assigned into 2 groups i) a group receiving standard follow-up and medical care, or ii) a group that will undergo a 11 months' Exercise Training program designed to improve bone health and reduce fall risk plus the standard follow-up and medical care. All patients will be assessed i) before the surgery, ii) one month, iii) 6 months, and iv) 12 months after the surgery. Assessments include: biochemical markers of bone turnover (BTM), BMD, bone tissue biomechanical properties, hormones involved in the regulation of energy, gastrointestinal and bone metabolism, body composition, BMI, nutritional intake, balance, muscle strength, cardiorespiratory fitness and daily physical activity. These evaluations will allow the investigators to understand the effects of an exercise-training program on bone metabolism of BS patients, contributing also to further elucidate the mechanisms underlying BS induced bone loss and fracture risk increase. The investigators will use established methods in the literature as well as novel procedures, which will enable them to overcome some of the limitations of previous studies. At the end of the study the investigators expect to have collected consistent data about whether an exercise-training program is or is not able to effectively prevent BS induced bone losses and fracture risk increases.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 25, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

October 31, 2017

Status Verified

October 1, 2017

Enrollment Period

1.9 years

First QC Date

July 14, 2016

Last Update Submit

October 28, 2017

Conditions

ObesityMetabolic Bone DiseaseAccidental Falls

Keywords

OsteoporosisBariatric SurgeryPhysical exerciseObesity

Outcome Measures

Primary Outcomes (3)

  • Bone mineral density

    Assayed by dual energy x-ray absorptiometry (DXA); g/cm2

    12 months

  • Biochemical marker of bone resorption

    Collagen type 1 cross-linked C-telopeptide (CTX; ng/mL)

    12 months

  • Bone Material Strength index (BMSi)

    Normalized parameter of bone material's resistance to indentation (OsteoProbe RUO)

    12 months

Study Arms (2)

Exercise training

EXPERIMENTAL

Exercise training plus standard medical follow-up care

Behavioral: Exercise training program

Standard medical care

ACTIVE COMPARATOR

Standard medical follow-up care only

Behavioral: Standard medical care

Interventions

Exercise training programBEHAVIORAL

Participants allocated to the "Exercise training plus standard medical care" group will undergo an exercise-training program of 11 months duration, 3 sessions/week, and 60 minutes/session, starting one month after the surgery. Each exercise session will be supervised and will include 5 major components: i) warm-up, ii) multidirectional jumps, iii) balance, iv) strength and, v) cool down. This structure is planned to meet two main objectives: i) enhance bone formation and, ii) reduce fall risk by improving muscle strength, cardiorespiratory fitness and balance.

Exercise training
Standard medical careBEHAVIORAL

Standard follow-up medical care following bariatric surgery

Standard medical care

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • meet the referral criteria for bariatric surgery;
  • BMI \>40 kg.m-2 or \>35 kg.m-2 with obesity-related comorbidities;
  • Motivation to participate in the study, regardless to the allocation group

You may not qualify if:

  • use of drugs that interfere with bone metabolism (i.e. bisphosphonates, teriparatide, calcitonin, hormone replacement therapy, chronic use of corticosteroids, thiazide diuretics);
  • Unable to perform exercise of moderate intensity;
  • Health condition that could be aggravated by exercise (i.e. uncontrolled arterial hypertension, severe kidney disease, class III New York Heart Association heart failure);
  • Peri-menopausal status with last menstruation \<1 year;
  • Known metabolic bone disease (i.e. Osteogenesis Imperfecta, Paget bone disease);
  • Concurrent participation in a structured exercise program (\>30 min in duration \>1 day/week);
  • Pregnancy or breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade de Desporto

Porto, 4200-450, Portugal

Location

Related Publications (1)

  • Boppre G, Diniz-Sousa F, Veras L, Bezerra A, Devezas V, Preto J, Santos-Sousa H, Oliveira J, Fonseca H. Impact of a Multicomponent Exercise Training Program on Muscle Strength After Bariatric Surgery: A Randomized Controlled Trial. Obes Surg. 2024 May;34(5):1704-1716. doi: 10.1007/s11695-024-07173-w. Epub 2024 Mar 27.

    PMID: 38532144DERIVED

Related Links

MeSH Terms

Conditions

ObesityBone Diseases, MetabolicOsteoporosisMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesBehavior

Study Officials

  • Hélder Fonseca, PhD

    CIAFEL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 14, 2016

First Posted

July 25, 2016

Study Start

April 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2019

Last Updated

October 31, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)