Effects of Resistance Training Programes At Different Intensities on Musculoskeletal, Metabolic, Lipid, Immunological, Inflammatory, Well-being and Functional Parameters in Older Adults.

The aging of the global population is recognized by the World Health Organization (WHO) as a major issue due to the disabilities and comorbidities related to this process, with women being the gender most affected. Due to the physiological and psychological age associated declines, physical activity and exercise are proven strategies for reducing the impact of aging. However, it is still unknown what kind of training program could be the most effective in reversing deleterious age-related changes in older adults. Regarding this, the type of training intensity and exercise modality are two key training parameters in exercise programming, and, therefore, different adaptations could be induced in older adults through the modification of these parameters. Furthermore, the type of training device is a significant factor and can act as a barrier or facilitator in older adults' participation in physical activities and exercise programs. Therefore, the research project primary goals are to compare the effects of resistance training programes performed at different intensities and materials during 32 weeks on a variety of physiological parameters in older adults.

Study Overview

• Status: Completed
• Conditions: Aging
• Intervention / Treatment: Behavioral: Elastic band-based resistance training program at high intensity (HI); Behavioral: Elastic band-based resistance training program at moderate-high intensity (MHI-bands); Behavioral: Elastic band-based resistance training program at moderate intensity (MI); Behavioral: Elastic tubes-based resistance training program at moderate-high intensity (MHI-tubes); Behavioral: Water-based resistance training program at moderate intensity (WMI)

Detailed Description

This is a randomized clinical trial (RCT) with 6 parallel arms. The subjects will be divided in 6 groups with a randomized technique assigned to a 32-week of: a) progressive elastic band-based resistance training program at high intensity (HI); b) progressive elastic band-based resistance training program at moderate-high intensity (MHI-bands); c) progressive elastic band-based resistance training program at moderate intensity (MI); d) progressive elastic tubes-based resistance training program at moderate-high intensity (MHI-tubes); e) progressive water-resistance training program at moderate intensity (WMI); f) self-management control group (CG). The subjects will be submitted to a 2-session familiarization period and then a 32-week of training program will be performed twice a week.

The exercise groups engaged in progressive elastic-based (bands of tubes) resistance training twice a week with three to four sets of six (HI), 10 (MHI) or 15 (MI) submaximal repetitions including six overall body exercises at a rate of perceived exertion (RPE) of 6-7 in the first four weeks and 8-9 in the remaining weeks on the OMNI-Resistance Exercise Scale (RES). The water-resistance group will perform similar exercises adapted to the water environment at maximal effort (maximal speed in the concentric and eccentric phases of each repetition) during 40 seconds. Members of the control group were instructed to continue their everyday lives.

Oxidative stress, bone health, body composition, neuromuscular strength, physical function, quality of life, lipidic, immune and cardiometabolic profile will be assessed. Oxidative stress status will be assessed in deoxyribonucleic acid (DNA) (urinary 8-oxo-2-deoxyguanosine [8-oxo-dG], lipids (F2-isoprostanes[8-iso-P]; malonaldehyde [MDA], and proteins (protein carbonyls) products together with antioxidant enzymes (superoxide dismutase [SOD] and glutathione peroxidase [GPx]), and thiol redox state (reduced glutathione [GSH], oxidized glutathione [GSSG], and the GSSG/GSH ratio. Bone health will be integrated by measures of areal bone mineral density (aBMD) and the T-score of the lumbar spine (L1-L4 segments, L2-L4 segments, and L1, L2, L3, and L4 individual vertebrae) and proximal femur (femoral neck, trochanter, intertrochanter, Ward's triangle, and total hip in both projects) will be assessed by dual-energy X-ray absorptiometry (DXA). Additionally bone health will be also composed by fracture risk (the 10-year probability of a major osteoporotic fracture and the 10-year probability of a hip fracture), bone turnover markers (BTMs) of bone formation (procollagen type I N propeptide [P1NP], a bone-specific isoform of alkaline phosphatase [bALP]) and bone resorption (a β-isomerized form of C-terminal telopeptide of type I collagen [β-CTx]), and their relationship (bALP/ β-CTx ratio). Body composition (total body mass, total fat mass, total fat-free mass, and total body fat percentage) will be measured by DXA. Moreover, the neuromuscular strength of upper limbs (elbow flexor and extensor muscles) and lower limbs (hip abductor and hip adductor along with knee flexor and extensor muscles) will be assessed through isokinetic dynamometry at low (60°/s) and high (180°/s) velocities. Finally, physical performance will be measured using various functional tests and batteries widely used in the literature, such as the 30 seconds chair stand (30sec-CS) and 30 seconds arm curl (30sec-AC) for muscle strength/endurance of the lower and upper limbs; time up and go (TUG) for dynamic balance/agility; the six-minute walking test (6MWT) for aerobic endurance; five sit-to stand.

• Study Type: Interventional
• Enrollment (Actual): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46020
    • Physical Activity and Sport Science Faculty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age > 60 years
• Physically independent (able to walk 100 m without a walking aid and climb 10 steps without rest)
• On the registration waiting list for physical activity at their respective Municipal Activity Centers for Older People (MACOP).
• Sedentary lifestyle (less than one hour of physical activity or exercise a week during the previous six months).
• Medical certificate of suitability or fitness to practice resistance training activities.
• No plans to leave the area during the intervention.
• Cognitive ability to understand and follow the instructions and sign the informed consent form.
• Free of any antioxidant supplements for at least six weeks before the start of this study.

Exclusion Criteria:

• Presence of cardiovascular, musculoskeletal, renal, liver, pulmonary, or neuromuscular and neurological disorders that would prevent the participant from performing the exercises.
• Current or prior (past six months) use of hormone replacement therapy.
• Body weight changes > 10% in the previous year.
• Intake of prescription medications or supplements (e.g., vitamins C, E) that were expected to alter the results of the study (ergogenic, dietary aids, estrogen, beta-blockers, steroid hormones, calcitonin, corticosteroids, glucocorticoids, thiazide diuretics, anticonvulsants, bisphosphonates, raloxifene).
• A history of malignant neoplasms.
• Terminal illness with life expectancy of less than one year.
• Engagement in regular strength training (more than once a week) during the previous six months.
• Participation in another research project (within the last six months) involving dietary, exercise, and/or pharmaceutical intervention.
• Mini mental State Examination lower than 23/30.
• Severe visual or hearing impairment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elastic band-based resistance training program at high intensity (HI)	Behavioral: Elastic band-based resistance training program at high intensity (HI); The training session will consist of 5-10 minutes of general warm-up (joint- mobility and aerobic exercises at low intensity); 35-40 minutes of the main part, which comprised six resistance exercises, three for upper limbs (upright rowing, incline rowing, and elbow curl) and three for lower limbs (narrow stance squat, lunge, and standing hip abduction) along with coordination exercises during the active rests; and 5-10 minutes of the cool-down routine (respiratory and flexibility exercises). The participants will perform 6 submaximal repetitions using elastic bands equivalent to 85% of the one-repetition maximum per exercise (high load/intensity training sessions). The perceived exertion level on the OMNI-RES scale progressed from 6-7 to 8-9 . The number of sets per exercise progressed from 3 to 4. The speed of execution of the exercises was controlled using a metronome marking the cadence (2s of concentric and eccentric phase).; Other Names: 1
Experimental: Elastic band-based resistance training program at moderate-high intensity (MHI-bands)	Behavioral: Elastic band-based resistance training program at moderate-high intensity (MHI-bands); The training session will consist of 5-10 minutes of general warm-up (joint- mobility and aerobic exercises at low intensity); 35-40 minutes of the main part, which comprised six resistance exercises, three for upper limbs (upright rowing, incline rowing, and elbow curl) and three for lower limbs (narrow stance squat, lunge, and standing hip abduction) along with coordination exercises during the active rests; and 5-10 minutes of the cool-down routine (respiratory and flexibility exercises). The participants will perform 6 submaximal repetitions using elastic bands equivalent to 75-80% of the one-repetition maximum per exercise (high to moderate load/intensity training sessions). The perceived exertion level on the OMNI-RES scale progressed from 6-7 to 8-9 . The number of sets per exercise progressed from 3 to 4. The speed of execution of the exercises was controlled using a metronome marking the cadence (2s of concentric and eccentric phase).; Other Names: 2
Experimental: Elastic band-based resistance training program at moderate intensity (MI)	Behavioral: Elastic band-based resistance training program at moderate intensity (MI); The training session will consist of 5-10 minutes of general warm-up (joint- mobility and aerobic exercises at low intensity); 35-40 minutes of the main part, which comprised six resistance exercises, three for upper limbs (upright rowing, incline rowing, and elbow curl) and three for lower limbs (narrow stance squat, lunge, and standing hip abduction) along with coordination exercises during the active rests; and 5-10 minutes of the cool-down routine (respiratory and flexibility exercises). The participants will perform 6 submaximal repetitions using elastic bands equivalent to 65-70% of the one-repetition maximum per exercise (moderate load/intensity training sessions). The perceived exertion level on the OMNI-RES scale progressed from 6-7 to 8-9. The number of sets per exercise progressed from 3 to 4. The speed of execution of the exercises was controlled using a metronome marking the cadence (2s of concentric and eccentric phase).; Other Names: 3
Experimental: Elastic tubes-based resistance training program at moderate-high intensity (MHI-tubes)	Behavioral: Elastic tubes-based resistance training program at moderate-high intensity (MHI-tubes); The training session will consist of 5-10 minutes of general warm-up (joint- mobility and aerobic exercises at low intensity); 35-40 minutes of the main part, which comprised six resistance exercises, three for upper limbs (upright rowing, incline rowing, and elbow curl) and three for lower limbs (narrow stance squat, lunge, and standing hip abduction) along with coordination exercises during the active rests; and 5-10 minutes of the cool-down routine (respiratory and flexibility exercises). The participants will perform 6 submaximal repetitions using elastic tubes equivalent to 75-80% of the one-repetition maximum per exercise (high to moderate load/intensity training sessions). The perceived exertion level on the OMNI-RES scale progressed from 6-7 to 8-9 . The number of sets per exercise progressed from 3 to 4. The speed of execution of the exercises was controlled using a metronome marking the cadence (2s of concentric and eccentric phase); Other Names: 4
Experimental: Water-based resistance training program at moderate intensity (WMI)	Behavioral: Water-based resistance training program at moderate intensity (WMI); The training session will consist of 5-10 minutes of general warm-up (joint- mobility and aerobic exercises at low intensity); 35-40 minutes of the main part, which comprised six resistance exercises, three for upper limbs (upright rowing, incline rowing, and elbow curl) and three for lower limbs (narrow stance leg extension and flexion, hip flexion and extension, and standing hip abduction) along with coordination exercises during the active rests; and 5-10 minutes of the cool-down routine (respiratory and flexibility exercises). The participants will perform in the poll the concentric and eccentric movements of each exercise at maximal velocity during 40 seconds (equivalent to working around 10 repetitions /75% 1RM each exercise). The perceived exertion level on the OMNI-RES scale progressed from 6-7 to 8-9. The number of sets per exercise progressed from 3 to 4.; Other Names: 5
No Intervention: Control group; Participants randomized into the CONTROL group will not undertake any formal intervention and will be asked to maintain their usual physical activity habits and diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in DNA oxidative stress	The oxidative stress of DNA will be assessed via urine collections of 8-oxo-7,8- dihydro-20-deoxyguanosine (8-OHdG) in nmol/mmol creatinine.	Baseline and 16 weeks
Change in lipid peroxidation	The lipid peroxidation will be assessed via urine and blood collections of 8-isoprostane(nmol /mmol creatinine) and Malondialdehyde (μmol/L)	Baseline and 16 weeks
Change in protein oxidation	The protein oxidation will be assessed via blood collections of protein carbonyl (nmol/L)	Baseline and 16 weeks
Change in antioxidants enzymes-Superoxid dismutase	The antioxidants enzymes will be assessed via blood collections of superoxid dismutase (U · mL-1)	Baseline and 16 weeks
Change in antioxidants enzymes-reduced glutathione	The antioxidants enzymes will be assessed via blood collections of reduced glutathione (nmol/mg protein)	Baseline and 16 weeks
Change in antioxidants enzymes- Glutathione peroxidase	The antioxidants enzymes will be assessed via blood collections of glutathione peroxidase (IU/g Hb).	Baseline and 16 weeks
Change in antioxidants enzymes-oxidized glutathione	The antioxidants enzymes will be assessed via blood collections of oxidized glutathione (nmol/mg protein).	Baseline and 16 weeks
Change in antioxidants enzymes-Catalase	The antioxidants enzymes will be assessed via blood collections of catalase (IU/g Hb).	Baseline and 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in inflammatory profile	The C-reactive protein (mg/L) and interleukin 6 (IL-6) will be assessed via blood collections.	Baseline, 16 and 32 weeks
Change in renal and hepatic profile	Glutamic-pyruvic transaminase (GPT), glutamic-oxaloacetic transaminase (GOT); gamma-glutamyl transpeptidase (GCT) and alkaline phosphatase (ALP) will be measured.	Baseline, 16 and 32 weeks
Change in metabolic profile-glycosylated hemoglobin A1C	The metabolic profile will be assessed via blood collections of glycosylated hemoglobin A1C (%).	Baseline, 16 and 32 weeks
Change in metabolic profile-basal glucose	The metabolic profile will be assessed via blood collections of basal glucose (mmol/l).	Baseline, 16 and 32weeks
Change in immune profile-Platelet counts	The immune profile will be assessed via blood collections of platelet counts (10*9/L).	Baseline, 16 and 32 weeks
Change in immune profile-plateletcrit	The immune profile will be assessed via blood collections of plateletcrit (%)	Baseline, 16 and 32 weeks
Change in immune profile-mean platelet volum	The immune profile will be assessed via blood collections of mean platelet volum (fl).	Baseline, 16 and 32 weeks
Change in immune profile-platelet distribution width	The immune profile will be assessed via blood collections of platelet distribution width (%).	Baseline, 16 and 32 weeks
Change in immune profile-leukocites	The immune profile will be assessed via blood collections of platelet counts leukocytes (% and 10*9/L).	Baseline, 16 and 32 weeks
Change in immune profile- neutrophils	The immune profile will be assessed via blood collections of neutrophils (% and 10*9/L).	Baseline, 16 and 32 weeks
Change in immune profile-lymphocytes	The immune profile will be assessed via blood collections of lymphocytes (% and 10*9/L).	Baseline, 16 and 32 weeks
Change in immune profile-monocytes	The immune profile will be assessed via blood collections of monocytes (% and 10*9/L).	Baseline, 16 and 32 weeks
Change in immune profile-eosinophils	The immune profile will be assessed via blood collections of eosinophils (% and 10*9/L).	Baseline, 16 and 32 weeks
Change in immune profile-basophils	The immune profile will be assessed via blood collections of basophils (% and 10*9/L).	Baseline, 16 and 32 weeks
Change in lipid profile-total cholesterol	The lipid profile will be assessed via blood collections: total cholesterol (mg/dL)	Baseline, 16 and 32 weeks
Change in lipid profile-high-density lipoprotein cholesterol	The lipid profile will be assessed via blood collections: high-density lipoprotein cholesterol (mg/dL).	Baseline, 16 and 32 weeks
Change in lipid profile-low-density lipoprotein cholesterol	The lipid profile will be assessed via blood collections: low-density lipoprotein cholesterol (mg/dL)	Baseline, 16 and 32 weeks
Change in lipid profile-triglycerides	The lipid profile will be assessed via blood collections triglycerides (mg/dL)	Baseline, 16 and 32 weeks
Change in lipid profile-apolipoprotein B/apolipoprotein A	The lipid profile will be assessed via blood collections: apolipoprotein B/apolipoprotein A (ApoB/ApoA) ratio	Baseline, 16 and 32 weeks
Change in bone metabolism - Type I procollagen N-terminal propeptide (Bone formation)	The bone metabolism will be assessed via blood collections of Type I procollagen N-terminal propeptide (P1NP).	Baseline, 16 and 32 weeks
Change in bone metabolism - Bone alkaline phosphatase (Bone formation)	The bone metabolism will be assessed via blood collections of bone alkaline phosphatase which are markers marker of bone formation.	Baseline, 16 and 32 weeks
Change in bone metabolism - terminal telopeptide of collagen type I (bone resorption)	The bone metabolism will be assessed via blood collections of terminal telopeptide of collagen type I (β-CTX- 1) which is a marker of bone resorption.	Baseline, 16 and 32 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of physical activity	The level of physical activity of the participants will be assessed by Global Physical Activity Questionnaire (GPAQ)	Baseline
Cognitive function	The cognitive function will be assessed by the Mini Mental State Examination (MMSE) questionnaire.	Baseline
Change in isokinetic muscle strength	The dynamic maximal concentric muscle strength of the dominant side of hip (flexo-extension and abduction and adduction muscle groups), knee and elbow (flexion and extension muscle groups) and shoulder (flexo-extension) will be measured with an isokinetic dynamometer (Biodex System 4 Pro; Biodex, Shirley, NY) at two angular velocities, 60°/s and 180°/s. Maximal voluntary concentric isokinetic torque will be assessed in Newton-meters (N-m).	Baseline, 16 and 32 weeks
Change in maximal muscle hand grip strength	The isometric maximal muscle hand grip strength of both hands will be measured with a dynamometer.	Baseline, 16 and 32 weeks
Change in maximal isometric strength	Maximal isometric strength of upper limbs (seated row exercise), lower limbs (leg press exercise) and back muscles (back extension)	Baseline, 16 and 32 weeks
Change in functional performance	The functional performance will be assessed with Senior Fitness tests that involve 6 tests: Arm Curl (number of biceps curl in 30 seconds); Chair Stand (stand up from a chair as often as possible within 30s); Back Scratch (for shoulder flexibility, cm between fingertips in the back); Chair sit and reach (for lower flexibility, cm between the extended middle fingers and the tip of the shoe); Up-and-Go (for dynamic balance, time for got up from the chair, walk as quickly as possible around a cone placed 2.4 m from the chair, and resume the seated position); Six-Minute walking test (for aerobic capacity, distance walked in 6 minutes).	Baseline, 16 and 32 weeks
Height	Height will be recorded to the nearest 0.01 cm using a stadiometer (Seca 711, Hamburg, Germany)	Baseline, 16 and 32 weeks
Change in bone mineral density (BMD)	BMD (g/cm2) will be assessed for whole body, proximal femur on the non-dominant side (femoral nech, trochanter, intertrochanter, Ward's triangle and total hip) and lumbar spine segments (L1-L4) (L2-L4) (L1-L3) and single vertebrae (L1, L2, L3, L4) will be assessed using a dual-energy-X ray fan beam absorptiometry (QDR® Hologic Discovery Wi, Hologic Inc., Waltham, MA, USA) equipped with APEX software (APEX Corp., version 12.4, Waltham, MA, USA).	Baseline, 16 and 32 weeks
Change bone mineral content (BMC)	BMC(g) will be assessed for whole body, proximal femur on the non-dominant side (femoral nech, trochanter, intertrochanter, Ward's triangle and total hip) and lumbar spine segments (L1-L4) (L2-L4) (L1-L3) and single vertebrae (L1, L2, L3, L4) will be assessed using a dual-energy-X ray fan beam absorptiometry (QDR® Hologic Discovery Wi, Hologic Inc., Waltham, MA, USA) equipped with APEX software (APEX Corp., version 12.4, Waltham, MA, USA).	Baseline, 16 and 32 weeks
Change T-Score	T-Score (SD) will be assessed for whole body, proximal femur on the non-dominant side (femoral nech, trochanter, intertrochanter, Ward's triangle and total hip) and lumbar spine segments (L1-L4) (L2-L4) (L1-L3) and single vertebrae (L1, L2, L3, L4) will be assessed using a dual-energy-X ray fan beam absorptiometry (QDR® Hologic Discovery Wi, Hologic Inc., Waltham, MA, USA) equipped with APEX software (APEX Corp., version 12.4, Waltham, MA, USA).	Baseline, 16 and 32 weeks
Change in Z-Score	Z-Score (SD) will be assessed for whole body, proximal femur on the non-dominant side (femoral nech, trochanter, intertrochanter, Ward's triangle and total hip) and lumbar spine segments (L1-L4) (L2-L4) (L1-L3) and single vertebrae (L1, L2, L3, L4) will be assessed using a dual-energy-X ray fan beam absorptiometry (QDR® Hologic Discovery Wi, Hologic Inc., Waltham, MA, USA) equipped with APEX software (APEX Corp., version 12.4, Waltham, MA, USA)	Baseline, 16 and 32 weeks
Change in fracture risk	Will be assessed via the FRAX ® tool.	Baseline, 16 and 32 weeks
Change in self-reported quality of life	Will be assessed via Short form quality of life questionnaire (SF36)	Baseline, 16 and 32 weeks
Change in basic activities of daily living	Will be assessed via Barthel index of activities of daily living.	Baseline
Change in instrumental activities of daily living	Will be assessed via Lawton and Brody instrumental activities of daily living scale. There are eight domains of function measured with the Lawton and Brody scale. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent).	Baseline
Attendance to training sessions	Daily training session attendance records will be collected by the instructors.	Baseline, 16 and 32 weeks
Adherence to training program	Adherence levels will be calculated at the end of the training period. Nonadherence is define as "those not attending at follow-up and have not attend for 4 weeks during the training period, and have not given a reason for nonattendance or those who have stated they are dropping out."	Week 32
Change in blood pressure	Systolic and diastolic blood pressure will be measured	Baseline, 16 and 32 weeks
Change balance based on body center of pressure	Balance will be measured through stabilometry over different surfaces (stable or unstable) and conditions (eyes open or close)	Baseline, 16 and 32 weeks
Change in body composition-Total mass, fat-free mass and fat mass	Total mass (Kg), fat-free mass (kg) and fat mass (kg) will be assessed for whole body and appendicular/visceral regions using a dual-energy-X ray fan beam absorptiometry (QDR® Hologic Discovery Wi, Hologic Inc., Waltham, MA, USA) equipped with APEX software (APEX Corp., version 12.4, Waltham, MA, USA).	Baseline, 16 and 32 weeks
Change in body composition- Percentage of body mass	Percentage of fat mass (%) of will be assessed for whole body and appendicular/visceral regions using a dual-energy-X ray fan beam absorptiometry (QDR® Hologic Discovery Wi, Hologic Inc., Waltham, MA, USA) equipped with APEX software (APEX Corp., version 12.4, Waltham, MA, USA).	Baseline, 16 and 32 weeks
Change in Body mass index	Body mass index was calculated.	Baseline, 16 and 32 weeks
Muscle quality of lower limbs	For lower limbs will be calculated based on ratio isocinetic torque in N-m Knee flexion or extension/leg muscle mass (N-m/kg)	Baseline, 16 and 32 weeks
Muscle quality of upper limbs	For upper limbs will be calculated based on ratio maximal grip strength arm muscle mass (Kg/Kg)	Baseline, 16 and 32 weeks

Collaborators and Investigators

• Sponsor: University of Valencia
• Collaborators: Oxidative Pathology Unit of the Department of Biochemistry and Molecular Biology, University of Valencia.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: September 18, 2024
• First Submitted That Met QC Criteria: September 25, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 25, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Oxidative stress; Physical activity; Aging; Dose-response; Bone health; Exercise intensities; Neuromuscular physiology
• Other Study ID Numbers: H1395923230221; OTR2015-140931NVES (Other Grant/Funding Number: MAPFRE Fundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No