NCT04375488

Brief Summary

The aim of the investigator's study is to investigate whether postoperative inspiratory muscle training and resistance exercise training has an effect on functional capacity, respiratory functions, respiratory muscle strength and endurance in patients undergoing bariatric surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 27, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2020

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2020

Completed
Last Updated

June 22, 2020

Status Verified

June 1, 2020

Enrollment Period

5 months

First QC Date

April 17, 2020

Last Update Submit

June 19, 2020

Conditions

Obesity, Morbid

Keywords

bariatric surgeryinspiratory muscle strengthrespiratory muscle endurancefunctional capacityperipheral muscle strengthquality of liferesistance exercise training6 - Minute Walk Test

Outcome Measures

Primary Outcomes (13)

  • Forced Vital Capacity (FVC)

    Respiratory Function Test

    3 months

  • Forced Expiratory Volume in 1 second (FEV1)

    Respiratory Function Test

    3 months

  • FEV1/FVC

    Respiratory Function Test

    3 months

  • Peak Expiratory Flow (PEF)

    Respiratory Function Test

    3 months

  • Forced expiratory flow over the middle one half of the FVC (FEF25-75%)

    Respiratory Function Test

    3 months

  • maximum inspiratory pressure (MIP)

    Respiratory Muscle Strength Test

    3 months

  • Maximal Voluntary Ventilation

    Respiratory Muscle Endurance Test

    3 months

  • Hand-held Dynamometer

    Dynamic Muscle Strength Test

    3 months

  • 5 times sit to stand test

    Mobility Test

    3 months

  • 6 minutes walking test

    functional capacity test

    3 months

  • Quality of Life Scale Specific for Obese Persons

    Quality of Life

    3 months

  • maximum expiratory pressure (MEP)

    Respiratory Muscle Strength Test

    3 months

  • Hand grip dynamometer

    Static Peripheral Muscle Strength Test

    3 months

Study Arms (3)

Resistance Exercise Training Group

EXPERIMENTAL

Resistance exercise training for 8 major muscle groups and 150 min per week walking suggestions were given

Other: Resistance Exercise Training

Inspiratory Muscle Training Group

EXPERIMENTAL

Resistance exercise training for 8 major muscle groups and inspiratory muscle strength training and 150 min per week walking suggestions were given

Other: Resistance Exercise TrainingOther: Inspiratory Muscle Training

Control Group

NO INTERVENTION

150 min per week walking suggestions were given.

Interventions

Resistance Exercise TrainingOTHER

60 minutes resistance exercise training for 8 major muscle groups (quadriceps, hamstring, biceps, triceps, pectoralis major, gluteus medius , gluteus maximus, middle part of deltoid) for 8 weeks, 3 times per week

Inspiratory Muscle Training GroupResistance Exercise Training Group
Inspiratory Muscle TrainingOTHER

with % 30 of MIP, 20 minutes inspiratory muscle training for 8 weeks, 3 times per week

Inspiratory Muscle Training Group

Eligibility Criteria

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

You may qualify if:

  • Having a body mass index (BMI) ≥40kg / m2 or
  • (BMI) ≥35kg/m2 and at least one concomitant disease associated with obesity
  • To participate regularly in treatment

You may not qualify if:

  • Using assistive device while walking
  • Lung infection in the past 1 month
  • Chronic obstructive pulmonary disease (COPD)
  • Having an orthopedic, neurological disease that will prevent him/her from exercising
  • Uncontrollable hypertension
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakıf Üniversitesi

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Alis Kostanoğlu

    Assistant professor

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2020

First Posted

May 5, 2020

Study Start

December 27, 2019

Primary Completion

May 21, 2020

Study Completion

June 18, 2020

Last Updated

June 22, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)