AgingNCT06618469
Effects of Resistance Training Programes At Different Intensities on Musculoskeletal, Metabolic, Lipid, Immunological, Inflammatory, Well-being and Functional Parameters in Older Adults.
A study testing Elastic band-based resistance training program at high intensity (HI), Elastic band-based resistance training program at moderate-high intensity (MHI-bands) and Elastic band-based resistance training program at moderate intensity (MI) in people with Aging, run by University of Valencia at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Aging
- What is being tested?
- Elastic band-based resistance training program at high intensity (HI), Elastic band-based resistance training program at moderate-high intensity (MHI-bands) and Elastic band-based resistance training program at moderate intensity (MI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteSpain
- Study dates
- May 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Physical activity and Sport Science Faculty
Valencia, Valencia, 46020
About this study
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.
Read the 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.
- Conditions
- Aging
- Being tested
- Elastic band-based resistance training program at high intensity (HI), Elastic band-based resistance training program at moderate-high intensity (MHI-bands), Elastic band-based resistance training program at moderate intensity (MI), Elastic tubes-based resistance training program at moderate-high intensity (MHI-tubes), Water-based resistance training program at moderate intensity (WMI)
- Keywords
- Aging, Dose-response, Exercise intensities, Oxidative stress, Physical activity, Bone health, Neuromuscular physiology
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elastic band-based resistance training program at high intensity (HI)Behavioural
Also called 1
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).
Elastic band-based resistance training program at moderate-high intensity (MHI-bands)Behavioural
Also called 2
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).
Elastic band-based resistance training program at moderate intensity (MI)Behavioural
Also called 3
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).
Elastic tubes-based resistance training program at moderate-high intensity (MHI-tubes)Behavioural
Also called 4
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)
Water-based resistance training program at moderate intensity (WMI)Behavioural
Also called 5
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.
| Study group | Role | What they receive |
|---|---|---|
| Elastic band-based resistance training program at high intensity (HI) | Experimental | Not described Receives: Behavioral: Elastic band-based resistance training program at high intensity (HI) |
| Elastic band-based resistance training program at moderate-high intensity (MHI-bands) | Experimental | Not described Receives: Behavioral: Elastic band-based resistance training program at moderate-high intensity (MHI-bands) |
| Elastic band-based resistance training program at moderate intensity (MI) | Experimental | Not described Receives: Behavioral: Elastic band-based resistance training program at moderate intensity (MI) |
| Elastic tubes-based resistance training program at moderate-high intensity (MHI-tubes) | Experimental | Not described Receives: Behavioral: Elastic tubes-based resistance training program at moderate-high intensity (MHI-tubes) |
| Water-based resistance training program at moderate intensity (WMI) | Experimental | Not described Receives: Behavioral: Water-based resistance training program at moderate intensity (WMI) |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: Baseline and 16 weeks
Change in protein oxidation
The protein oxidation will be assessed via blood collections of protein carbonyl (nmol/L)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: Baseline and 16 weeks
Change in antioxidants enzymes-Catalase
The antioxidants enzymes will be assessed via blood collections of catalase (IU/g Hb).
Measured: Baseline and 16 weeks
Secondary outcomes (22)
Change in inflammatory profile
The C-reactive protein (mg/L) and interleukin 6 (IL-6) will be assessed via blood collections.
Measured: 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.
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 (%).
Measured: 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).
Measured: 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).
Measured: Baseline, 16 and 32 weeks
Change in immune profile-plateletcrit
The immune profile will be assessed via blood collections of plateletcrit (%)
Measured: 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).
Measured: 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 (%).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline, 16 and 32 weeks
Change in lipid profile-total cholesterol
The lipid profile will be assessed via blood collections: total cholesterol (mg/dL)
Measured: 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).
Measured: 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)
Measured: Baseline, 16 and 32 weeks
Change in lipid profile-triglycerides
The lipid profile will be assessed via blood collections triglycerides (mg/dL)
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline, 16 and 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study startMay 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, duoble-blind (sport scientiest assistance/care assistance-outcome assessor), 6 arms prospective parallel design clinical trial. The older adults will be recruited from the Municipal Activity Centers for Older People located in Valencia and will be randomized in a prospective clinical trial study with a 6 parallel arms study design to a tubes or bands or water resistance training modalities performed at different intensities or a control group over a 32 weeks period.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Oxidative Pathology Unit of the Department of Biochemistry and Molecular Biology, University of Valencia.
- Responsible party
- Principal investigator, Juan C. Colado, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618469
- Sponsor's protocol ID
- H1395923230221
- Other IDs
- OTR2015-140931NVES
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resistance Training Programes At Different Intensities on Musculoskeletal, Metabolic, Lipid, Immunological, Inflammatory, Well-being and Functional Parameters in Older Adults.
- ClinicalTrials.gov ID
- NCT06618469
- Acronym / sponsor ID
- H1395923230221
- Conditions
- Aging
- Keywords
- Aging, Dose-response, Exercise intensities, Oxidative stress, Physical activity, Bone health, Neuromuscular physiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Oxidative Pathology Unit of the Department of Biochemistry and Molecular Biology, University of Valencia.
- Study start
- May 2014 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 6
- Model description
- This is a randomized, duoble-blind (sport scientiest assistance/care assistance-outcome assessor), 6 arms prospective parallel design clinical trial. The older adults will be recruited from the Municipal Activity Centers for Older People located in Valencia and will be randomized in a prospective clinical trial study with a 6 parallel arms study design to a tubes or bands or water resistance training modalities performed at different intensities or a control group over a 32 weeks period.
| Arm | Type | Receives |
|---|---|---|
| Elastic band-based resistance training program at high intensity (HI) | Experimental | Behavioral: Elastic band-based resistance training program at high intensity (HI) |
| Elastic band-based resistance training program at moderate-high intensity (MHI-bands) | Experimental | Behavioral: Elastic band-based resistance training program at moderate-high intensity (MHI-bands) |
| Elastic band-based resistance training program at moderate intensity (MI) | Experimental | Behavioral: Elastic band-based resistance training program at moderate intensity (MI) |
| Elastic tubes-based resistance training program at moderate-high intensity (MHI-tubes) | Experimental | Behavioral: Elastic tubes-based resistance training program at moderate-high intensity (MHI-tubes) |
| Water-based resistance training program at moderate intensity (WMI) | Experimental | Behavioral: Water-based resistance training program at moderate intensity (WMI) |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elastic band-based resistance training program at high intensity (HI)Also: 1The 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). | Behavioural | Elastic band-based resistance training program at high intensity (HI) |
| Elastic band-based resistance training program at moderate-high intensity (MHI-bands)Also: 2The 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). | Behavioural | Elastic band-based resistance training program at moderate-high intensity (MHI-bands) |
| Elastic band-based resistance training program at moderate intensity (MI)Also: 3The 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). | Behavioural | Elastic band-based resistance training program at moderate intensity (MI) |
| Elastic tubes-based resistance training program at moderate-high intensity (MHI-tubes)Also: 4The 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) | Behavioural | Elastic tubes-based resistance training program at moderate-high intensity (MHI-tubes) |
| Water-based resistance training program at moderate intensity (WMI)Also: 5The 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. | Behavioural | Water-based resistance training program at moderate intensity (WMI) |
Primary outcome
Change in DNA oxidative stress
Time frame: Baseline and 16 weeks
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.
Change in lipid peroxidation
Time frame: Baseline and 16 weeks
The lipid peroxidation will be assessed via urine and blood collections of 8-isoprostane(nmol /mmol creatinine) and Malondialdehyde (μmol/L)
Change in protein oxidation
Time frame: Baseline and 16 weeks
The protein oxidation will be assessed via blood collections of protein carbonyl (nmol/L)
Change in antioxidants enzymes-Superoxid dismutase
Time frame: Baseline and 16 weeks
The antioxidants enzymes will be assessed via blood collections of superoxid dismutase (U · mL-1)
Change in antioxidants enzymes-reduced glutathione
Time frame: Baseline and 16 weeks
The antioxidants enzymes will be assessed via blood collections of reduced glutathione (nmol/mg protein)
Change in antioxidants enzymes- Glutathione peroxidase
Time frame: Baseline and 16 weeks
The antioxidants enzymes will be assessed via blood collections of glutathione peroxidase (IU/g Hb).
Change in antioxidants enzymes-oxidized glutathione
Time frame: Baseline and 16 weeks
The antioxidants enzymes will be assessed via blood collections of oxidized glutathione (nmol/mg protein).
Change in antioxidants enzymes-Catalase
Time frame: Baseline and 16 weeks
The antioxidants enzymes will be assessed via blood collections of catalase (IU/g Hb).
22 secondary outcomes
Change in inflammatory profile
Time frame: Baseline, 16 and 32 weeks
Change in renal and hepatic profile
Time frame: Baseline, 16 and 32 weeks
Change in metabolic profile-glycosylated hemoglobin A1C
Time frame: Baseline, 16 and 32 weeks
Change in metabolic profile-basal glucose
Time frame: Baseline, 16 and 32weeks
Change in immune profile-Platelet counts
Time frame: Baseline, 16 and 32 weeks
Change in immune profile-plateletcrit
Time frame: Baseline, 16 and 32 weeks
Change in immune profile-mean platelet volum
Time frame: Baseline, 16 and 32 weeks
Change in immune profile-platelet distribution width
Time frame: Baseline, 16 and 32 weeks
Change in immune profile-leukocites
Time frame: Baseline, 16 and 32 weeks
Change in immune profile- neutrophils
Time frame: Baseline, 16 and 32 weeks
Change in immune profile-lymphocytes
Time frame: Baseline, 16 and 32 weeks
Change in immune profile-monocytes
Time frame: Baseline, 16 and 32 weeks
Change in immune profile-eosinophils
Time frame: Baseline, 16 and 32 weeks
Change in immune profile-basophils
Time frame: Baseline, 16 and 32 weeks
Change in lipid profile-total cholesterol
Time frame: Baseline, 16 and 32 weeks
Change in lipid profile-high-density lipoprotein cholesterol
Time frame: Baseline, 16 and 32 weeks
Change in lipid profile-low-density lipoprotein cholesterol
Time frame: Baseline, 16 and 32 weeks
Change in lipid profile-triglycerides
Time frame: Baseline, 16 and 32 weeks
Change in lipid profile-apolipoprotein B/apolipoprotein A
Time frame: Baseline, 16 and 32 weeks
Change in bone metabolism - Type I procollagen N-terminal propeptide (Bone formation)
Time frame: Baseline, 16 and 32 weeks
Change in bone metabolism - Bone alkaline phosphatase (Bone formation)
Time frame: Baseline, 16 and 32 weeks
Change in bone metabolism - terminal telopeptide of collagen type I (bone resorption)
Time frame: Baseline, 16 and 32 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elastic band-based resistance training program at high intensity (HI), Elastic band-based resistance training program at moderate-high intensity (MHI-bands) and Elastic band-based resistance training program at moderate intensity (MI) in people with Aging, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in DNA oxidative stress (time frame: Baseline and 16 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.