Aged, 80 and OverRETONCT04999501
Resistance-type Exercise Training in the Older Population
A study testing Prolonged resistance-type exercise training in people with Aged, 80 and Over and Resistance Training, run by Universidad de La Frontera at 1 site in Chile.
Trial summary
Background: Aging is associated with muscle mass and strength loss and "oldest" old people (≥85 y) are at a far greater risk of developing sarcopenia. Training increases muscle mass and strength in a variety of populations, yet the efficacy has not been clearly defined for individuals in the fourth age (≥80 y). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aged, 80 and Over, Resistance Training
- What is being tested?
- Prolonged resistance-type exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChile
- Study dates
- 10 Jun 2018to 30 Oct 2022
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged from 65-75 and 85 and more years.
- 18.5 < BMI < 30 kg/m2.
- Older people that are still "community-dwelling", i.e., not living in a nursing-home or elderly-home.
Who cannot join
- Performing regular resistance training (2 or more times per week, carrying out progressive training) in the previous 6 months.
- Cardiovascular diseases that are contradictory for physical activity (not included controlled Hypertension).
- All co-morbidities interacting with mobility and muscle metabolism of the body and that do not allow to (safely) perform the resistance-type exercise program (e.g. debilitating arthritis, spasticity/rigidity, all neurological disorders and paralysis).
Trial locations and contacts
1 site in 1 country.
Chile1 site
Department of Internal Medicine, Faculty of Medicine, Universidad de La Frontera. Temuco, Chile
Temuco
About this study
Official title: Comparison of the Benefits of Prolonged Resistance-type Exercise Training in the Older Population Aged 65-75 y Versus 85 y and Over
Background: Aging is associated with muscle mass and strength loss and "oldest" old people (≥85 y) are at a far greater risk of developing sarcopenia. Training increases muscle mass and strength in a variety of populations, yet the efficacy has not been clearly defined for individuals in the fourth age (≥80 y).
Hypothesis: The following hypotheses will be investigated:
Read more
- Twelve weeks of progressive resistance-type exercise training increases muscle mass and strength in young old (65-75 y) and oldest old (85 y and over) subjects.
- The training-induced increase in muscle mass and strength is relatively greater in young old subjects when compared to oldest old subjects.
Goals: The primary aim of this study is to compare the effect of resistance-type exercise training on skeletal muscle mass (i.e. quadriceps cross-sectional area and whole body lean mass) in young old and oldest old subjects.
Specific goals
- Determine whether resistance-type exercise training can increase muscle mass and muscle strength in young old and oldest old subjects.
- Determine whether resistance-type exercise training can improve physical performance in young old and oldest old subjects.
- Identify whether inflammatory markers (i.e., TNFα, IL-4, IL-6, IL-10, IL-13) are up- or down-regulated in young old and oldest old subjects before and after resistance-type exercise training.
Methodology:
Study design Sixty older females and males (young old group: n=30, 65-75 y; oldest old group: n=30, 85 y and over) will be included in this prospective clinical trial. All volunteers will be subjected to 12 weeks of whole-body resistance-type exercise training (3x/wk). Before, and after 6 and 12 weeks of training, a computed tomography (CT) scan of the upper leg will be performed to assess quadriceps cross sectional area. On those days, fasting blood samples will be obtained and whole-body dual energy x-ray absorptiometry (DEXA) scan will also be performed. Maximal strength will be determined by 1-repetition maximum (1RM) and physical functioning by the short physical performance battery (SPPB) at the same time points.
Read the detailed description
Background: Aging is associated with muscle mass and strength loss and "oldest" old people (≥85 y) are at a far greater risk of developing sarcopenia. Training increases muscle mass and strength in a variety of populations, yet the efficacy has not been clearly defined for individuals in the fourth age (≥80 y). A better understanding of the skeletal muscle adaptive response to resistance-type exercise training with advanced age will provide a strong basis to develop and implement care programs within our rapidly aging population, in which the "oldest" old represent the fastest growing group.
Hypothesis: The following hypotheses will be investigated:
- Twelve weeks of progressive resistance-type exercise training increases muscle mass and strength in young old (65-75 y) and oldest old (85 y and over) subjects.
- The training-induced increase in muscle mass and strength is relatively greater in young old subjects when compared to oldest old subjects.
Goals: The primary aim of this study is to compare the effect of resistance-type exercise training on skeletal muscle mass (i.e. quadriceps cross-sectional area and whole body lean mass) in young old and oldest old subjects.
Specific goals
- Determine whether resistance-type exercise training can increase muscle mass and muscle strength in young old and oldest old subjects.
- Determine whether resistance-type exercise training can improve physical performance in young old and oldest old subjects.
- Identify whether inflammatory markers (i.e., TNFα, IL-4, IL-6, IL-10, IL-13) are up- or down-regulated in young old and oldest old subjects before and after resistance-type exercise training.
Methodology:
Study design Sixty older females and males (young old group: n=30, 65-75 y; oldest old group: n=30, 85 y and over) will be included in this prospective clinical trial. All volunteers will be subjected to 12 weeks of whole-body resistance-type exercise training (3x/wk). Before, and after 6 and 12 weeks of training, a computed tomography (CT) scan of the upper leg will be performed to assess quadriceps cross sectional area. On those days, fasting blood samples will be obtained and whole-body dual energy x-ray absorptiometry (DEXA) scan will also be performed. Maximal strength will be determined by 1-repetition maximum (1RM) and physical functioning by the short physical performance battery (SPPB) at the same time points.
Study parameters/endpoints
- The main study endpoint is the increase in quadriceps cross-sectional area as assessed via CT scan.
- Secondary endpoints include: Whole-body and segmental body composition (i.e., lean mass, fat mass, bone mineral content; DEXA scan); Maximal strength assessment (1RM); Hand grip strength; Short physical performance battery (SPPB); Inflammatory and molecular markers (blood samples analysis).
- Other study parameters include: Age, body weight, body height, body mass index (BMI), lipid profile, glucose, and insulin.
Expected results:
The impact of resistance-type exercise training to increase muscle mass and strength in the oldest old population remains unclear. With the proposed project, we expect that resistance-type exercise training will increase muscle mass and strength, although the impact will be relatively lower in the oldest old group when compared with a group of young old individuals. The potential findings will define the efficacy of resistance-type exercise training to increase muscle mass and strength in individuals with advancing age. Better maintenance, or even an increase in muscle mass and strength increases independence, prolonging good health, recovery from disease and illness, and ultimately decreases burden on healthcare systems. This information will have a beneficial impact in the exercise physiology and aging areas for future interventions at the local, regional, national and international levels.
- Conditions
- Aged, 80 and Over, Resistance Training
- Being tested
- Prolonged resistance-type exercise training
- Keywords
- oldest old, exercise, muscle mass, strength, functional capacity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged resistance-type exercise trainingOther
All volunteers will be subjected to 12 weeks of whole-body resistance-type exercise training (3x/wk).
| Study group | Role | What they receive |
|---|---|---|
| 65 - 75 years | Experimental | All volunteers aged 65 - 75 will be subjected to 12 weeks of full body resistance exercise training (3 times per week). Receives: Other: Prolonged resistance-type exercise training |
| 85 years and over | Experimental | All volunteers over the age of 85 will be subjected to 12 weeks of full body resistance exercise training (3 times per week). Receives: Other: Prolonged resistance-type exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in skeletal muscle mass (measured via Computed tomography (CT) scan) after prolonged resistance-type exercise training
Cross-sectional area of the quadriceps and L3 region via single-slice CT scan
Measured: Before, and after 6 and 12 weeks of training
Secondary outcomes (5)
Change in lean tissue (measured via Dual Energy X-ray Absorptiometry (DEXA) scan) after prolonged resistance-type exercise training
Measurement of Whole Body Composition via DEXA
Measured: Before, and after 6 and 12 weeks of training
Change in arms and legs strength (measured via 1-Repetition Maximum (1RM) testing) after prolonged resistance-type exercise training
Maximal strength assessment via 1RM testing of horizontal row, lat pull down, chest press, leg press, and leg extension)
Measured: Before, and after 6 and 12 weeks of training
Change in hand grip strength (measured via JAMAR handheld dynamometer) after prolonged resistance-type exercise training
Maximal strength assessment via 1RM testing of JAMAR handheld dynamometer.
Measured: Before, and after 6 and 12 weeks of training
Change in physical performance (measured via Short physical performance battery (SPPB)) after prolonged resistance-type exercise training
Measurement of physical performance via SPPB
Measured: Before, and after 6 and 12 weeks of training
Change in Inflammatory markers via ELISA after prolonged resistance-type exercise training
Measurement in blood samples via ELISA
Measured: Before, and after 6 and 12 weeks of training,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start10 Jun 2018
- Primary completion8 Jul 2021
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aged, 80 and OverStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de La Frontera
- Sponsor type
- University, hospital or other
- Collaborators
- Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
- Responsible party
- Principal investigator, Gabriel Nasri Marzuca-Nassr, Universidad de La Frontera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999501
- Sponsor's protocol ID
- FONDECYT 11180949
- Acronym
- RETO
- Status last verified
- Nov 2022
- First submitted
- 26 Jul 2021
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Benefits of Prolonged Resistance-type Exercise Training in the Older Population Aged 65-75 y Versus 85 y and Over
- ClinicalTrials.gov ID
- NCT04999501
- Acronym / sponsor ID
- RETO / FONDECYT 11180949
- Conditions
- Aged, 80 and Over, Resistance Training
- Keywords
- oldest old, exercise, muscle mass, strength, functional capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Universidad de La FronteraUniversity, hospital or other
- Collaborators
- Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
- Study start
- 10 Jun 2018 (actual)
- Primary completion
- 8 Jul 2021 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 11 Aug 2021 (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.
Background: Aging is associated with muscle mass and strength loss and "oldest" old people (≥85 y) are at a far greater risk of developing sarcopenia. Training increases muscle mass and strength in a variety of populations, yet the efficacy has not been clearly defined for individuals in the fourth age (≥80 y).
Hypothesis: The following hypotheses will be investigated:
- Twelve weeks of progressive resistance-type exercise training increases muscle mass and strength in young old (65-75 y) and oldest old (85 y and over) subjects.
- The training-induced increase in muscle mass and strength is relatively greater in young old subjects when compared to oldest old subjects.
Goals: The primary aim of this study is to compare the effect of resistance-type exercise training on skeletal muscle mass (i.e. quadriceps cross-sectional area and whole body lean mass) in young old and oldest old subjects.
Specific goals
- Determine whether resistance-type exercise training can increase muscle mass and muscle strength in young old and oldest old subjects.
- Determine whether resistance-type exercise training can improve physical performance in young old and oldest old subjects.
- Identify whether inflammatory markers (i.e., TNFα, IL-4, IL-6, IL-10, IL-13) are up- or down-regulated in young old and oldest old subjects before and after resistance-type exercise training.
Methodology:
Study design Sixty older females and males (young old group: n=30, 65-75 y; oldest old group: n=30, 85 y and over) will be included in this prospective clinical trial. All volunteers will be subjected to 12 weeks of whole-body resistance-type exercise training (3x/wk). Before, and after 6 and 12 weeks of training, a computed tomography (CT) scan of the upper leg will be performed to assess quadriceps cross sectional area. On those days, fasting blood samples will be obtained and whole-body dual energy x-ray absorptiometry (DEXA) scan will also be performed. Maximal strength will be determined by 1-repetition maximum (1RM) and physical functioning by the short physical performance battery (SPPB) at the same time points.
Detailed description
Background: Aging is associated with muscle mass and strength loss and "oldest" old people (≥85 y) are at a far greater risk of developing sarcopenia. Training increases muscle mass and strength in a variety of populations, yet the efficacy has not been clearly defined for individuals in the fourth age (≥80 y). A better understanding of the skeletal muscle adaptive response to resistance-type exercise training with advanced age will provide a strong basis to develop and implement care programs within our rapidly aging population, in which the "oldest" old represent the fastest growing group.
Hypothesis: The following hypotheses will be investigated:
- Twelve weeks of progressive resistance-type exercise training increases muscle mass and strength in young old (65-75 y) and oldest old (85 y and over) subjects.
- The training-induced increase in muscle mass and strength is relatively greater in young old subjects when compared to oldest old subjects.
Goals: The primary aim of this study is to compare the effect of resistance-type exercise training on skeletal muscle mass (i.e. quadriceps cross-sectional area and whole body lean mass) in young old and oldest old subjects.
Specific goals
- Determine whether resistance-type exercise training can increase muscle mass and muscle strength in young old and oldest old subjects.
- Determine whether resistance-type exercise training can improve physical performance in young old and oldest old subjects.
- Identify whether inflammatory markers (i.e., TNFα, IL-4, IL-6, IL-10, IL-13) are up- or down-regulated in young old and oldest old subjects before and after resistance-type exercise training.
Methodology:
Study design Sixty older females and males (young old group: n=30, 65-75 y; oldest old group: n=30, 85 y and over) will be included in this prospective clinical trial. All volunteers will be subjected to 12 weeks of whole-body resistance-type exercise training (3x/wk). Before, and after 6 and 12 weeks of training, a computed tomography (CT) scan of the upper leg will be performed to assess quadriceps cross sectional area. On those days, fasting blood samples will be obtained and whole-body dual energy x-ray absorptiometry (DEXA) scan will also be performed. Maximal strength will be determined by 1-repetition maximum (1RM) and physical functioning by the short physical performance battery (SPPB) at the same time points.
Study parameters/endpoints
- The main study endpoint is the increase in quadriceps cross-sectional area as assessed via CT scan.
- Secondary endpoints include: Whole-body and segmental body composition (i.e., lean mass, fat mass, bone mineral content; DEXA scan); Maximal strength assessment (1RM); Hand grip strength; Short physical performance battery (SPPB); Inflammatory and molecular markers (blood samples analysis).
- Other study parameters include: Age, body weight, body height, body mass index (BMI), lipid profile, glucose, and insulin.
Expected results:
The impact of resistance-type exercise training to increase muscle mass and strength in the oldest old population remains unclear. With the proposed project, we expect that resistance-type exercise training will increase muscle mass and strength, although the impact will be relatively lower in the oldest old group when compared with a group of young old individuals. The potential findings will define the efficacy of resistance-type exercise training to increase muscle mass and strength in individuals with advancing age. Better maintenance, or even an increase in muscle mass and strength increases independence, prolonging good health, recovery from disease and illness, and ultimately decreases burden on healthcare systems. This information will have a beneficial impact in the exercise physiology and aging areas for future interventions at the local, regional, national and international levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 65 - 75 years | Experimental | Other: Prolonged resistance-type exercise trainingAll volunteers aged 65 - 75 will be subjected to 12 weeks of full body resistance exercise training (3 times per week). |
| 85 years and over | Experimental | Other: Prolonged resistance-type exercise trainingAll volunteers over the age of 85 will be subjected to 12 weeks of full body resistance exercise training (3 times per week). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Aged from 65-75 and 85 and more years.
- 18.5 < BMI < 30 kg/m2.
- Older people that are still "community-dwelling", i.e., not living in a nursing-home or elderly-home.
Key exclusion criteria (3 listed)
- Performing regular resistance training (2 or more times per week, carrying out progressive training) in the previous 6 months.
- Cardiovascular diseases that are contradictory for physical activity (not included controlled Hypertension).
- All co-morbidities interacting with mobility and muscle metabolism of the body and that do not allow to (safely) perform the resistance-type exercise program (e.g. debilitating arthritis, spasticity/rigidity, all neurological disorders and paralysis).
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 |
|---|---|---|
| Prolonged resistance-type exercise trainingAll volunteers will be subjected to 12 weeks of whole-body resistance-type exercise training (3x/wk). | Other | 65 - 75 years, 85 years and over |
Primary outcome
Change in skeletal muscle mass (measured via Computed tomography (CT) scan) after prolonged resistance-type exercise training
Time frame: Before, and after 6 and 12 weeks of training
Cross-sectional area of the quadriceps and L3 region via single-slice CT scan
5 secondary outcomes
Change in lean tissue (measured via Dual Energy X-ray Absorptiometry (DEXA) scan) after prolonged resistance-type exercise training
Time frame: Before, and after 6 and 12 weeks of training
Change in arms and legs strength (measured via 1-Repetition Maximum (1RM) testing) after prolonged resistance-type exercise training
Time frame: Before, and after 6 and 12 weeks of training
Change in hand grip strength (measured via JAMAR handheld dynamometer) after prolonged resistance-type exercise training
Time frame: Before, and after 6 and 12 weeks of training
Change in physical performance (measured via Short physical performance battery (SPPB)) after prolonged resistance-type exercise training
Time frame: Before, and after 6 and 12 weeks of training
Change in Inflammatory markers via ELISA after prolonged resistance-type exercise training
Time frame: Before, and after 6 and 12 weeks of training,
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 3 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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 Prolonged resistance-type exercise training in people with Aged, 80 and Over and Resistance Training, run by Universidad de La Frontera at 1 site in Chile.
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 3 inclusion and 3 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 3 Nov 2022. 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 Chile. 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 skeletal muscle mass (measured via Computed tomography (CT) scan) after prolonged resistance-type exercise training (time frame: Before, and after 6 and 12 weeks of training). 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 3 Nov 2022.