Effects of twelve weeks of telecare-based elastic band resistance exercise training after laparoscopic sleeve gastrectomy in physical fitness, body composition and nutritional intake

ISRCTN	ISRCTN10259827
DOI	https://doi.org/10.1186/ISRCTN10259827
Sponsor	E-DA Hospital
Funder	E-DA Hospital

Submission date: 10/12/2025
Registration date: 30/12/2025
Last edited: 29/12/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Plain English summary of protocol not provided at registration

Contact information

Prof Nai Jen Chang
Principal investigator, Public, Scientific

100, Shiquan 1st Rd., Sanmin Dist.
Kaohsiung
807
Taiwan

ORCID ID	0000-0001-8408-8334
Phone	+886-7-3121101 ext. 2646
Email	njchang@kmu.edu.tw

Miss Wan Ling Tu
Principal investigator, Public, Scientific

No. 1, Yida Road, Jiaosu Village, Yanchao District, Kaohsiung City
Kaohsiung
824
Taiwan

ORCID ID	0009-0006-0850-6331
Phone	+886-7-6150011 ext. 257625
Email	i74261269@gmail.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Open (masking not used)
Control	Placebo
Assignment	Parallel
Purpose	Supportive care
Scientific title	A randomized controlled trial investigating the effects of a 12-week telehealth resistance-training program on preservation of fat-free mass and improvement of physical fitness in adults undergoing sleeve gastrectomy compared with usual postoperative care
Study objectives	The primary objective is to determine whether a 12-week telehealth elastic-band resistance training program can reduce the loss of fat-free mass and improve physical fitness in adults undergoing laparoscopic sleeve gastrectomy. Secondary objectives include evaluating changes in body composition, muscle strength, balance, dynamic balance, agility, biochemical markers, and dietary intake following the intervention.
Ethics approval(s)	Approved 02/08/2024, Institutional Review Board of the E-DA Hospital (No. 6, Yida Road, Jiasu Village, Yanchao District, Kaohsiung City, 824, Taiwan; +886-7-6151100 ext. 5109; ed114818@edah.org.tw), ref: EMRP-113-060
Health condition(s) or problem(s) studied	Severe obesity requiring bariatric surgery (laparoscopic sleeve gastrectomy)
Intervention	Intervention group: Participants received a 12-week telehealth elastic-band resistance training program. The program included structured weekly exercise sessions delivered via online video guidance and remote supervision. Exercises targeted major muscle groups and were performed using elastic resistance bands, with progressive intensity based on individual tolerance. Participants were instructed to complete the training 3 times per week. Control group: Participants received usual postoperative care following laparoscopic sleeve gastrectomy, including standard clinical follow-up and general lifestyle advice, but did not receive structured exercise training.
Intervention type	Behavioural
Primary outcome measure(s)	Static balance performance measured using the single-leg stance test with eyes open; the longest time (seconds) from two trials was recorded at at baseline (postoperative month 3, prior to intervention) and after the 12-week intervention period Lower extremity muscle strength measured using the 30-second Chair Stand Test (number of repetitions completed in 30 seconds) at at baseline (postoperative month 3, prior to intervention) and after the 12-week intervention period Handgrip strength measured using a handgrip dynamometer; two trials on the dominant hand with the best value recorded (kg) at at baseline (postoperative month 3, prior to intervention) and after the 12-week intervention period Functional mobility and agility measured using the Timed Up and Go (TUG) test; time required to stand up, walk 3 meters, turn, return, and sit down (seconds) at at baseline (postoperative month 3, prior to intervention) and after the 12-week intervention period
Key secondary outcome measure(s)	Fat mass, fat-free mass, skeletal muscle mass, percent body fat, visceral fat, total body water, and basal metabolic rate measured using Bioelectrical Impedance Analysis (BIA) using the BC-710 body composition analyzer at at baseline (postoperative month 3, prior to intervention) and after the 12-week intervention period Body weight, body mass index, waist circumference, hip circumference, blood pressure, and heart rate measured using standard clinical measurements at at baseline (postoperative month 3, prior to intervention) and after the 12-week intervention period Glycated hemoglobin, fasting glucose, insulin, lipid profile, liver and renal function markers, hematological indices, and iron-related parameters measured using data collected from the hospital electronic medical record system obtained after standard laboratory blood testing at at baseline (postoperative month 3, prior to intervention) and after the 12-week intervention period Total energy intake, macronutrient intake, and macronutrient distribution measured using three-day dietary records assessed by a registered dietitian at at baseline (postoperative month 3, prior to intervention) and after the 12-week intervention period
Completion date	23/10/2025

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	20 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	51
Total final enrolment	34
Key inclusion criteria	1. Adults aged 20–65 years undergoing laparoscopic sleeve gastrectomy 2. Diagnosed with severe obesity and eligible for bariatric surgery 3. Willing and medically able to participate in a 12-week postoperative telehealth resistance-training program 4. Able to provide informed consent
Key exclusion criteria	1. Those who have previously undergone bariatric surgery 2. Drug addiction 3. Malignant tumor patients 4. Patients whose mobility is limited and who cannot perform physical fitness activities 5. Pregnancy 6. Chronic obstructive pulmonary disease 7. Neurological or musculoskeletal diseases 8. Patients who refuse to sign the study consent form 9. Patients who, or whose caregivers, are unable to use mobile communication software
Date of first enrolment	02/08/2024
Date of final enrolment	31/07/2025

Locations

Countries of recruitment

Taiwan

Study participating centre

International Weight Loss and Diabetes Surgery Center, E-Da Hospital, Kaohsiung, Taiwan

No. 1, Yida Road, Jiaosu Village, Yanchao District
Kaohsiung City
824
Taiwan

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan

Editorial Notes

10/12/2025: Study’s existence confirmed by the E-Da Medical Foundation, E-Da Hospital Human Trials and Research Committee, Taiwan.