NCT03724461

Brief Summary

There are no unbiased studies that have analyzed the effects of resistance training with traditional, heavy versus light-moderate loads on muscle, tendon and bone in elderly people. The purpose of the present study is to assess the effects on muscle mass and function, tendon and bone of two different training intensities, light-moderate vs. heavy load, in people older than 65 years old. The study will be carried out with a randomized controlled design. Participants will perform single training sessions and a 12-wk dynamic resistance training program on the knee extensors with different training intensities on each leg. One leg will train with heavy loads and the other one will train with light-moderate loads, but matching the load x repetitions performed by the contralateral side.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 18, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 30, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2020

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

2.5 years

First QC Date

September 18, 2018

Last Update Submit

June 15, 2020

Conditions

Keywords

resistance trainingsarcopeniahypertrophytendonfrailtyageing

Outcome Measures

Primary Outcomes (4)

  • Acute change in muscle size (cross sectional area, cm2)

    Ultrasound-based determination quadriceps muscle size and architecture.

    Change from baseline at 5 minutes after a training session

  • Change in muscle size (cross sectional area, cm2)

    Ultrasound-based determination quadriceps muscle size and architecture.

    Change from baseline to week 12

  • Acute change in muscle function (N)

    Force-velocity profile of the single-leg press exercise

    Change from baseline at 5 minutes after a training session

  • Change in muscle function (N)

    Force-velocity profile of the single-leg press exercise

    Change from baseline to week 12

Secondary Outcomes (15)

  • Change in patellar tendon stiffness (N/mm)

    Change from baseline to week 12

  • Acute change in patellar tendon stiffness (N/mm)

    Change from baseline at 5 minutes after a training session

  • Change in muscle mass (kg)

    Change from baseline to week 12

  • Change in bone mass (g)

    Change from baseline to week 12

  • Acute change in muscle excitation (mV)

    Change from baseline at 5 minutes after a training session

  • +10 more secondary outcomes

Study Arms (5)

High intensity vs Control (12 weeks)

ACTIVE COMPARATOR

8 weeks of baseline period plus an exercise program where one leg undergoes High Intensity resistance training (12 weeks) and the other leg is established as control.

Behavioral: High Intensity resistance training (12 weeks)Behavioral: Control (12 weeks)

Light intensity vs Control (12 weeks)

ACTIVE COMPARATOR

8 weeks of baseline period plus an exercise program where one leg undergoes light-moderate intensity resistance training (12 weeks) and the other leg is established as control.

Behavioral: Light-moderate intensity resistance training (12 weeks)Behavioral: Control (12 weeks)

High vs Light intensity (12 weeks)

EXPERIMENTAL

8 weeks of baseline period plus an exercise program where one leg undergoes High Intensity resistance training (12 weeks) and the other leg undergoes light-moderate intensity resistance training.

Behavioral: High Intensity resistance training (12 weeks)Behavioral: Light-moderate intensity resistance training (12 weeks)

High intensity (Acute)

EXPERIMENTAL

Analysis of the effects of one High Intensity resistance training session, with a crossover design.

Behavioral: One High Intensity resistance training session

Light intensity (Acute)

EXPERIMENTAL

Analysis of the effects of one Light-moderate Intensity resistance training session, with a crossover design.

Behavioral: One Light-moderate intensity resistance training session

Interventions

High intensity resistance training (80% of 1 repetition maximum), 2 d/wk (Longitudinal)

Also known as: HIT
High intensity vs Control (12 weeks)High vs Light intensity (12 weeks)

Light-moderate intensity resistance training (40% of 1 repetition maximum), 2 d/wk (Longitudinal)

Also known as: LIT
High vs Light intensity (12 weeks)Light intensity vs Control (12 weeks)

No resistance training during the intervention period.

Also known as: CON
High intensity vs Control (12 weeks)Light intensity vs Control (12 weeks)

High intensity resistance training, 1 training session

Also known as: HIT (Acute)
High intensity (Acute)

Light-moderate intensity resistance training, 1 training session

Also known as: LIT (Acute)
Light intensity (Acute)

Eligibility Criteria

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

You may qualify if:

  • years and older,
  • non-institutionalized
  • passed physical examination including physical function assessment (no frailty status; SPPB \>7 points)

You may not qualify if:

  • Neurological, musculoskeletal, or other disorder that would preclude completing resistance training and all performance tests
  • Uncontrolled hypertension, unstable or exercise-induced angina pectoris or myocardial ischemia or any other medical condition that would interfere with testing or increase one's risk of complications during exercise.
  • History of regular resistance exercise during the previous 3 years
  • Knee prosthesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Castilla-La Mancha, Laboratorio de Actividad Física y Función Muscular. Campus de la Fábrica de Armas. Avda. Carlos III s/n

Toledo, 45071, Spain

Location

Related Publications (3)

  • Rodriguez-Lopez C, Alcazar J, Sanchez-Martin C, Baltasar-Fernandez I, Ara I, Csapo R, Alegre LM. Contralateral Adaptations After Unilateral Power Training in Older Adults: The Effect of Intensity of Load. Scand J Med Sci Sports. 2025 Nov;35(11):e70165. doi: 10.1111/sms.70165.

  • Rodriguez-Lopez C, Alcazar J, Losa-Reyna J, Martin-Espinosa NM, Baltasar-Fernandez I, Ara I, Csapo R, Alegre LM. Effects of Power-Oriented Resistance Training With Heavy vs. Light Loads on Muscle-Tendon Function in Older Adults: A Study Protocol for a Randomized Controlled Trial. Front Physiol. 2021 Feb 18;12:635094. doi: 10.3389/fphys.2021.635094. eCollection 2021.

  • Rodriguez-Lopez C, Alcazar J, Sanchez-Martin C, Ara I, Csapo R, Alegre LM. Mechanical Characteristics of Heavy vs. Light Load Ballistic Resistance Training in Older Adults. J Strength Cond Res. 2022 Aug 1;36(8):2094-2101. doi: 10.1519/JSC.0000000000003826. Epub 2020 Sep 16.

MeSH Terms

Conditions

SarcopeniaHypertrophyFrailty

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsPathologic Processes

Study Officials

  • Luis M. Alegre, PhD

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 18, 2018

First Posted

October 30, 2018

Study Start

September 1, 2017

Primary Completion

March 12, 2020

Study Completion

March 12, 2020

Last Updated

June 16, 2020

Record last verified: 2020-06

Locations