Effect of a Concurrent Exercise Program on Muscle Quality, Body Composition, Functional Response, and Quality of Life in Individuals Undergoing Bariatric Surgery: Protocol for a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Change in rectus femoris muscle quality (echo intensity; grayscale units 0-255)
研究概览
简要总结
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.
详细描述
Bariatric surgery is an effective treatment for severe obesity; however, the early postoperative period is frequently associated with loss of lean body mass, reduced muscle strength, and functional decline, which may negatively affect recovery and quality of life. Physical exercise has been proposed as a key component of metabolic rehabilitation, although evidence regarding structured concurrent exercise programs initiated early after bariatric surgery remains limited, particularly with respect to muscle quality.
The aim of this study is to evaluate the effect of a 5-week concurrent exercise program on rectus femoris muscle quality in individuals undergoing bariatric surgery, compared with a control group receiving usual kinesiology care. Secondary objectives include evaluating changes in body composition, functional response, and quality of life, as well as exploring the association between exercise adherence and the magnitude of observed changes.
This is a single-center, prospective, longitudinal, randomized controlled clinical trial with two parallel groups (intervention and control). A total of 87 adults aged 18-60 years who have undergone sleeve gastrectomy or Roux-en-Y gastric bypass at Clínica BUPA Santiago and have a medical indication for metabolic rehabilitation will be recruited. Participants will undergo baseline assessment during the fourth postoperative week and will then be randomly allocated in a 1:1 ratio to the intervention or control group using a sequence generated and administered by an individual independent of the assessors and treating physical therapists.
The intervention group will participate in a structured, semi-supervised 5-week concurrent exercise program designed according to the FITT principle (Frequency, Intensity, Time, and Type of exercise). The program will combine aerobic and resistance training and will include two supervised in-person sessions per week (10 sessions in total) plus one complementary home-based session each week. Aerobic training will progress from continuous moderate-intensity exercise to interval training, whereas resistance training will progressively increase training volume for large muscle groups. Exercise intensity will be monitored using the Borg Rating of Perceived Exertion scale, and resistance loads will be individually adjusted according to each participant's clinical tolerance.
Participants allocated to the control group will continue receiving usual kinesiology care and standard clinical management according to the institutional metabolic rehabilitation protocol at Clínica BUPA Santiago. This program will also follow the FITT principle and will include two supervised sessions per week consisting of continuous aerobic exercise, targeted muscle strengthening, and static stretching, consistent with routine clinical practice, without the structured progression incorporated into the concurrent exercise program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the intervention, participants and treating physical therapists cannot be blinded to group allocation. However, outcome assessors responsible for baseline and post-intervention evaluations will remain blinded to treatment allocation. Assessors will have no access to the randomization sequence, and participants will be instructed not to disclose their assigned intervention during outcome assessments.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-60 years.
- •Participants eligible for the institutional PAD (Pago Asociado a Diagnóstico) bariatric surgery program with medical indication for metabolic rehabilitation.
- •Undergoing sleeve gastrectomy or Roux-en-Y gastric bypass at Clínica BUPA Santiago.
- •Medical indication for metabolic rehabilitation.
- •Able and willing to provide written informed consent.
排除标准
- •Type 1 diabetes mellitus or type 2 diabetes mellitus with severe complications (including stage G4-G5 nephropathy, severe autonomic neuropathy, or high risk of exercise-related hypoglycemia).
- •Severe musculoskeletal disorders limiting participation in the exercise program.
- •Acute cardiovascular event within the previous 3 months or medical contraindication to supervised exercise.
- •Severe cardiorespiratory disease or dyspnea at rest or with minimal exertion.
- •Dependence on supplemental oxygen.
- •Bariatric surgery complications (e.g., leak, bleeding, stenosis, or intra-abdominal abscess).
- •Liver failure, kidney failure, or any other clinical condition compromising safe participation in the exercise program.
研究组 & 干预措施
Concurrent Physical Exercise Program
Participants allocated to the intervention group will complete a structured, semi-supervised concurrent exercise program during the postoperative period following bariatric surgery. Participants will enter the study during postoperative week 4 and undergo a baseline assessment before starting the intervention. The program will last 5 weeks and will include 10 supervised in-person sessions (2 sessions/week, approximately 60 minutes each) and one complementary home-based session per week. After completion of the intervention, participants will remain one week without supervised exercise sessions before the week 7 follow-up assessment.
干预措施: Concurrent Exercise Program (Behavioral)
Usual Metabolic Rehabilitation Program
Participants allocated to the control group will receive the usual metabolic rehabilitation program at Clínica BUPA Santiago. The rehabilitation program will follow the FITT principle (Frequency, Intensity, Time, and Type of exercise) and will include two supervised sessions per week for 5 weeks consisting of continuous aerobic exercise, targeted muscle strengthening, and stretching according to the institutional protocol. All participants will undergo baseline and week 7 assessments.
干预措施: Usual Metabolic Rehabilitation Program (Behavioral)
结局指标
主要结局
Change in rectus femoris muscle quality (echo intensity; grayscale units 0-255)
时间窗: Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).
Muscle quality will be assessed by ultrasound as echo intensity (mean grayscale value, 0-255) within a standardized region of interest, analyzed using ImageJ, at baseline and post-intervention. Change will be calculated as Δ = post - pre.
次要结局
- Change in intramuscular fat infiltration assessed by ultrasound echo intensity (grayscale units 0-255)(Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of intervention and 1 week of rest).)
- Change in fat mass (kg)(Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).)
- Change in skeletal muscle mass (kg)(Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).)
- Change in 1-minute Sit-to-Stand performance (1min-STST)(Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).)
- Adherence to the exercise program (supervised in-clinic sessions)(During the 5-week intervention period (calculated at the end of the program based on attendance to the 10 supervised sessions).)
- Change in percent body fat (%)(Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).)
- Change in visceral fat area (cm²)(Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).)
- Change in basal metabolic rate (kcal/day)(Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).)
- Change in rectus femoris muscle thickness (cm)(Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).)
- Change in rectus femoris cross-sectional area (cm²)(Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).)
- Change in fat infiltration measured by ultrasound in the rectus femoris (cm)(Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).)
- Change in quality of life assessed by the Moorehead-Ardelt II questionnaire(Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).)
研究者
María José Pabst
Principal Investigator (Physiotherapist/Doctoral Candidate)
Universidad Autónoma de Chile