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IRCT20241205063953N7 IRCT 2026-09-12 Islamic Azad University Effect of Progressive Resistance Training and Nano-Curcumin on Physical Performance in Older Adults with Sarcopenia Independent and Combined Effects of Progressive Resistance Training and Nano-Curcumin on Physical Performance and Muscle Health in Older Adults with Confirmed Sarcopenia: A 2×2 Factorial Randomized Placebo-Controlled Trial 2026-09-21 anticipated 252 Recruiting https://irct.ir/trial/93028 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Supportive, Randomization description: Participants will be randomly allocated in a 1:1:1:1 ratio to the four study groups. The randomization sequence will be generated by an independent statistician using variable block randomization stratified by study center, sex, and sarcopenia severity. Allocation concealment will be ensured using a central randomization system or sequentially numbered, opaque, sealed envelopes, Blinding description: Participants, outcome assessors, laboratory personnel, and data analysts will be blinded to nano-curcumin or placebo allocation. Nano-curcumin and placebo capsules will be identical in appearance and packaging and independently coded. Due to the nature of the resistance training intervention, blinding of participants and trainers to exercise allocation is not feasible; however, outcome assessors and data analysts will remain blinded to group allocation. N/A Sarcopenia. Intervention 1: Intervention group 1: Participants in this group will receive progressive resistance training for 16 weeks, three sessions per week. The exercise program will include resistance exercises targeting major upper and lower limb muscles with gradually increasing intensity under supervision of a trained instructor. In addition, participants will receive nano-curcumin 40 mg twice daily. Intervention 2: Intervention group 2: Participants in this group will receive progressive resistance training for 16 weeks, three sessions per week. The exercise program will include resistance exercises targeting major muscle groups with gradually increasing intensity under supervision of a trained instructor. This group will receive a placebo identical to nano-curcumin. Intervention 3: Intervention group 3: Participants in this group will receive nano-curcumin 40 mg twice daily for 16 weeks. Participants will receive usual lifestyle advice and will not participate in the resistance training program. Intervention 4: Control group: Participants in this group will receive placebo identical to nano-curcumin for 16 weeks. The placebo will be identical in appearance, packaging, and physical characteristics to the nano-curcumin product. Participants will not participate in the resistance training program. Yes - There is a plan to make this available What will be shared: De-identified individual participant data, study protocol, statistical analysis plan, analysis codes, and data dictionary will be made available to qualified researchers after publication of the primary study results. Requests will be reviewed by the research team based on scientific and ethical considerations. When: Access to data and documents will begin 6 months after publication of the primary study results and will remain available for 5 years. To whom: Academic researchers, scientists from research institutions, and qualified investigators submitting a valid scientific request will be eligible for access. Conditions: Data will be available for scientific research purposes, valid analyses, and advancing knowledge in multiple sclerosis and exercise science. Data reuse must comply with research ethics principles and must not attempt participant re-identification. Where to obtain: Requests for data access should be submitted to the corresponding investigator through the official email address of the research center. Final contact information will be provided after publication of the primary study results. How to obtain: Requests will be reviewed by the research team. After scientific and ethical approval, a data use agreement will be completed and access to de-identified data will be provided. Comments:
public Akram Jafari
Rahmatieh, Islamic Azad University Shahrekord Branch
Shahrekord Iran (Islamic Republic of) 8817630003 +98 38 3336 1001 jafari.akm@gmail.com Islamic Azad University scientific Akram Jafari
Rahmatieh, Islamic Azad University Shahrekord Branch
Shahrekord Iran (Islamic Republic of) 8817630003 +98 38 3336 1001 Jafari.akm@gmail.com Islamic Azad University Iran (Islamic Republic of) Age between 65 and 85 years Ability to provide written informed consent Confirmed sarcopenia according to the EWGSOP2 criteria Low muscle strength based on handgrip strength or five-times chair stand test Low appendicular skeletal muscle index measured by dual-energy X-ray absorptiometry Baseline SPPB score between 4 and 10 No regular resistance training during the previous three months Stable use of major medications and supplements for at least four weeks before enrollment Medical clearance for participation in moderate-to-high intensity resistance training 65 years 85 years Both Unstable cardiovascular disease or uncontrolled hypertension Recent stroke or major surgery M62.5 Muscle wasting and atrophy, not elsewhere classified Rehabilitation Rehabilitation Lifestyle Placebo Intervention group 1: Participants in this group will receive progressive resistance training for 16 weeks, three sessions per week. The exercise program will include resistance exercises targeting major upper and lower limb muscles with gradually increasing intensity under supervision of a trained instructor. In addition, participants will receive nano-curcumin 40 mg twice daily. Intervention group 2: Participants in this group will receive progressive resistance training for 16 weeks, three sessions per week. The exercise program will include resistance exercises targeting major muscle groups with gradually increasing intensity under supervision of a trained instructor. This group will receive a placebo identical to nano-curcumin. Intervention group 3: Participants in this group will receive nano-curcumin 40 mg twice daily for 16 weeks. Participants will receive usual lifestyle advice and will not participate in the resistance training program. Control group: Participants in this group will receive placebo identical to nano-curcumin for 16 weeks. The placebo will be identical in appearance, packaging, and physical characteristics to the nano-curcumin product. Participants will not participate in the resistance training program. Change in total Short Physical Performance Battery score from baseline to week 16. Timepoint: Measurement at baseline before intervention initiation and at week 16 after completion of the intervention. Method of measurement: Using the Short Physical Performance Battery assessment including balance test, walking speed test, and chair stand test, performed by a trained outcome assessor blinded to group allocation. Knee extension muscle strength. Timepoint: Measurement at baseline before intervention initiation and at week 16 after completion of the intervention. Method of measurement: Using an isokinetic dynamometer to assess knee extension strength by a trained assessor. Appendicular skeletal muscle index. Timepoint: Measurement at baseline before intervention initiation and at week 16 after completion of the intervention. Method of measurement: Using dual energy X ray absorptiometry to measure appendicular lean mass divided by height squared. Quadriceps muscle quality. Timepoint: Measurement at baseline before intervention initiation and at week 16 after completion of the intervention. Method of measurement: Using muscle ultrasound to assess muscle thickness and echo intensity of the quadriceps muscles including rectus femoris and vastus lateralis. Sarcopenia related quality of life. Timepoint: Measurement at baseline before intervention initiation and at week 16 after completion of the intervention. Method of measurement: Using the validated Persian version of the sarcopenia specific quality of life questionnaire. Handgrip strength. Timepoint: Measurement at baseline, week 8, and week 16. Method of measurement: Using a standard handgrip dynamometer in a seated position according to a standardized handgrip strength assessment protocol. Knee extension muscle strength. Timepoint: At baseline before intervention initiation and at the end of week 16. Method of measurement: Measured using an isokinetic dynamometer. Appendicular skeletal muscle mass index. Timepoint: At baseline and at the end of week 16. Method of measurement: Appendicular lean mass measured by dual-energy X-ray absorptiometry and divided by height squared. Quadriceps muscle thickness. Timepoint: At baseline and at the end of week 16. Method of measurement: Measured by muscle ultrasound in the rectus femoris and vastus lateralis using standardized settings. Quadriceps muscle echo intensity. Timepoint: At baseline and at the end of week 16. Method of measurement: Measured from grayscale ultrasound images of the rectus femoris and vastus lateralis using fixed ultrasound settings. Sarcopenia-specific quality of life score. Timepoint: At baseline and at the end of week 16. Method of measurement: Measured using the validated Persian version of the Sarcopenia Quality of Life questionnaire. Handgrip strength. Timepoint: At baseline, week 8, and the end of week 16. Method of measurement: Measured using a standard handgrip dynamometer according to a standardized assessment protocol. Walking speed. Timepoint: At baseline, week 8, and the end of week 16. Method of measurement: Measured using the standardized four-meter walking speed test. Five-times chair stand test time. Timepoint: At baseline, week 8, and the end of week 16. Method of measurement: Measured as the time required to complete five consecutive chair stands according to a standardized protocol. Timed Up and Go test time. Timepoint: At baseline, week 8, and the end of week 16. Method of measurement: Measured as the time required to stand from a chair, walk three meters, return, and sit down according to a standardized protocol. Serum irisin concentration. Timepoint: At baseline and at the end of week 16. Method of measurement: Measured in serum using a validated enzyme-linked immunosorbent assay kit in the central laboratory. High-sensitivity C-reactive protein concentration. Timepoint: At baseline and at the end of week 16. Method of measurement: Measured in serum at the central laboratory using a validated laboratory assay. Serum interleukin 6 concentration. Timepoint: At baseline and at the end of week 16. Method of measurement: Measured in serum using a validated immunoassay in duplicate at the central laboratory. Serum tumor necrosis factor alpha concentration. Timepoint: At baseline and at the end of week 16. Method of measurement: Measured in serum using a validated immunoassay in duplicate at the central laboratory. Serum insulin-like growth factor 1 concentration. Timepoint: At baseline and at the end of week 16. Method of measurement: Measured in serum using a validated laboratory assay at the central laboratory. Serum myostatin concentration. Timepoint: At baseline and at the end of week 16. Method of measurement: Measured in serum using a validated immunoassay at the central laboratory. Serum alanine aminotransferase concentration. Timepoint: At baseline, week 8, and the end of week 16. Method of measurement: Measured using a standard clinical blood chemistry assay. Serum aspartate aminotransferase concentration. Timepoint: At baseline, week 8, and the end of week 16. Method of measurement: Measured using a standard clinical blood chemistry assay. Serum alkaline phosphatase concentration. Timepoint: At baseline, week 8, and the end of week 16. Method of measurement: Measured using a standard clinical blood chemistry assay. IR.IAU.SHK.REC.1405.110 کمیته اخلاق دانشگاه ازاد اسلامی واحد شهرکرد Islamic Azad University Approved 2026-06-10 Ethics Committee of Islamic Azad University, Shahrekord Branch Rahmatieh, Islamic Azad University Shahrekord Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)