Concurrent Exercise Effects in Post-Bariatric Patients

Study acronym: BAR-EX
StatusRecruiting
PhaseNot applicable
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Interventions modified Show 5 more changesShow less
    • Enrollment target: 84 to 87
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints revised (11)
    • Study description shortened, about 121 words
    • Publications: details revised at 11 of 12 entries
  2. Notable Primary endpoint(s) modifiedv3 Show 6 more changesShow less
    • Enrollment increased: 68 → 84 participants
    • Trial arms changed: 1 → 2
    • Secondary endpoints: 8 to 11
    • Study title shortened, about 6 words
    • Eligibility criteria shortened, about 5 words
    • Study description shortened, about 1 word
  3. Notable Trial status: Active, Not Recruiting to Recruitingv2 Show 7 more changesShow less
    • Primary completion date: Dec 31, 2026 to Dec 31, 2027
    • Primary endpoints: 3 to 4
    • Study completion date: Jan 31, 2027 to Dec 31, 2028
    • Secondary endpoints: 1 to 8
    • Study description expanded, about 184 words
    • Site details revised
    • Study title shortened, about 5 words
  4. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study aims to evaluate the effect of a 5-week concurrent exercise program (aerobic and resistance training) on muscle quality, body composition, functional response, and quality of life in individuals undergoing bariatric surgery. This is a single-center, prospective, longitudinal, randomized controlled clinical trial with two parallel groups: an intervention group and a control group. A total of 87 adults aged 18 to 60 years who have undergone sleeve gastrectomy or Roux-en-Y gastric bypass and have a medical indication for metabolic rehabilitation will be recruited. The intervention group will participate in a structured, semi-supervised concurrent exercise program for 5 weeks, consisting of two in-person sessions per week (10 sessions in total), whereas the control group will continue receiving usual kinesiology care and standard clinical management according to the institutional rehabilitation protocol at Clínica BUPA Santiago. All participants will be assessed at two time points: baseline, during the fourth postoperative week, and at week 7. The primary outcome will be the change in rectus femoris muscle quality assessed by ultrasound (echo intensity). Secondary outcomes will include body composition (bioelectrical impedance analysis), functional response (One-minute Sit-to-Stand Test), and quality of life (Moorehead-Ardelt II questionnaire). Additionally, adherence to the exercise program in the intervention group will be assessed as the percentage of attendance at supervised exercise sessions, and its association with the magnitude of changes in study outcomes will be explored. The findings are expected to provide clinically relevant evidence regarding the effectiveness of exercise during the early postoperative period and to contribute to the optimization of metabolic rehabilitation strategies following bariatric surgery.
Trial Details
NCT Number NCT07423780
Lead Sponsor Universidad Autónoma de Chile
Collaborators: Clinica Bupa Santiago
Conditions
(from sponsor)
Obesity & Overweight, Post-bariatric Surgery
Related terms Obesity, Overweight
Enrollment 87 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov