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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Chile

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.

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 groups in NCT04999501
Study groupRoleWhat they receive
65 - 75 yearsExperimentalAll 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 overExperimentalAll 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  1. First posted11 Aug 2021
  2. Study start10 Jun 2018
  3. Primary completion8 Jul 2021
  4. Study completion30 Oct 2022

Resources

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)
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

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.

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