Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04999501 |
| Other study ID # |
FONDECYT 11180949 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 10, 2018 |
| Est. completion date |
October 30, 2022 |
Study information
| Verified date |
November 2022 |
| Source |
Universidad de La Frontera |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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).
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.
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.
