NCT04999501

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2021

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 11, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
Last Updated

November 3, 2022

Status Verified

November 1, 2022

Enrollment Period

3.1 years

First QC Date

July 26, 2021

Last Update Submit

November 1, 2022

Conditions

Keywords

oldest oldexercisemuscle massstrengthfunctional capacity

Outcome Measures

Primary Outcomes (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

    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

    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

    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

    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

    Before, and after 6 and 12 weeks of training

  • Change in Inflammatory markers via ELISA after prolonged resistance-type exercise training

    Before, and after 6 and 12 weeks of training,

Study Arms (2)

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).

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).

Other: Prolonged resistance-type exercise training

Interventions

All volunteers will be subjected to 12 weeks of whole-body resistance-type exercise training (3x/wk).

65 - 75 years85 years and over

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged from 65-75 and 85 and more years.
  • \< BMI \< 30 kg/m2.
  • Older people that are still "community-dwelling", i.e., not living in a nursing-home or elderly-home.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine, Faculty of Medicine, Universidad de La Frontera. Temuco, Chile

Temuco, Chile

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 26, 2021

First Posted

August 11, 2021

Study Start

June 10, 2018

Primary Completion

July 8, 2021

Study Completion

October 30, 2022

Last Updated

November 3, 2022

Record last verified: 2022-11

Locations