NCT03551132

Brief Summary

Physical exercise is considered an important intervention for promoting well-being and healthy aging. The purpose of the present study was to determine the effects of moderate-to-high intensity resistance training circuit on different parameters of fat mass, functional autonomy, strength and quality of life in elderly. A randomized controlled trial was conducted. A total of 45 subjects, (27 females, 18 males) aged between 65-75 years old from Murcia (Spain) were randomly to experimental group (resistance training circuit for 12-weeks and isocaloric diet program) and control group (no resistance training intervention). Fat mass, functional autonomy, muscular strength, perceived exertion, and quality of life perception were obtained with validated tools. Experimental group decreases significantly their fat mass percentage whilst control group not presented differences. Muscular strength results exhibited significant differences between intervention training protocol. Furthermore, experimental group presented better marks than control group at quality of life questionnaire and functional autonomy scores. The moderate-to-high intensity resistance training circuit showed increase in upper and lower muscular strength as well as functional capacity and significantly decreased total fat mass and that improvements in physical function predict improvements in QoL perception in elderly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

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

First Submitted

Initial submission to the registry

May 15, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

May 15, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 11, 2018

Completed
Last Updated

June 11, 2018

Status Verified

May 1, 2018

Enrollment Period

Same day

First QC Date

May 15, 2018

Last Update Submit

May 27, 2018

Conditions

Keywords

elderlyresistance traininghealth

Outcome Measures

Primary Outcomes (7)

  • body weight in kilograms

    was measured after removal of shoes and heavy outer clothing, using a Tanita BC-418 MA (Tanita Corporation, Arlington Heights, IL) to the nearest 0.1 kg.

    Change from Baseline body weight (kg) at 12 weeks

  • height in meters

    Standing height without shoes was measured using a Seca 202 stadiometer (Seca, Hamburg, Germany) to the nearest 0.1 cm.

    Change from Baseline standing height (cm) at 12 weeks

  • Body Mass Index (BMI)

    was calculated as the ratio of weight to squared height in kg/m\^2

    Change from Baseline Body Mass Index (BMI): (kg/m^2) at 12 weeks

  • % Fat mass

    % fat mass was measured after removal of shoes and heavy outer clothing, using a Tanita BC-418 MA (Tanita Corporation, Arlington Heights, IL) to the nearest 0.1 kg.

    Change from Baseline bioelectrical impedance % fat mass at 12 weeks

  • Quality of life

    Quality of Life in the elderly (WHOQOL-OLD) is an instrument developed by Power et al., translated and validated for the Spanish language. The WHOQOL-OLD is a 24-item self-report instrument that is divided into six Facets. Is also calculated from the set of 24 items. Answers are based on a 5-point Likert response scale

    Change from Baseline Quality of Life perception at 12 weeks

  • Functional autonomy

    The Latin American Group for Maturity (GDLAM) protocol was used to evaluate functional autonomy. It is composed of five tests: W10m; SSP; SPP; SCMA; PTS. These tests are used in a mathematical formula to calculate the GDLAM index (GI).

    Change from Baseline Functional autonomy at 12 weeks

  • Muscular strength

    The predicted 1-repetition maximum (1-RM) testing protocol followed the procedure previously described by Brzycki. Upper body muscles strength and lower body strength was measured

    Change from Baseline Muscular Strength at 12 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

Experimental group A supervised progressive moderate-to-high RTC program designed to induce muscular hypertrophy was performed. EG followed a progressive moderate-to-high RTC program for 12-weeks. The training program incorporated resistance exercise of six major regions and consisted of 3 training sessions per week on non-consecutive days (Monday, Wednesday and Friday). All subjects performed the sets with moderate-intensity (8 to 12 repetitions) in each exercise and 30-60 seconds rest between sets. The load was increased during the 12 weeks from 60% 1-RM to high-intensity 80% 1-RM. The training load was increased when the individual could perform more than the prescribed number of repetitions (12 repetitions) followed the OMNI-RES scale and a hard effort perception level. Rest between sets was 1-2 minutes.

Other: Exercise test

Group 2

NO INTERVENTION

Control group The CG not participated in the RTC program.

Interventions

Fat mass, Functional autonomy, muscular strength, quality of life questionnaire

Group 1

Eligibility Criteria

Age65 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age ≥ 65 years.
  • Never attended classes of fitness academies or following Physical Activity.
  • No experience in Resistance Training.

You may not qualify if:

  • No history of neuromuscular, metabolic, hormonal, cardiovascular diseases.
  • Not taking any medication that could influence hormonal and neuromuscular metabolism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pablo Jorge Marcos Pardo

Murcia, 30011, Spain

Location

MeSH Terms

Conditions

SarcopeniaBody Weight Changes

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsBody Weight

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: A randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 15, 2018

First Posted

June 11, 2018

Study Start

May 15, 2018

Primary Completion

May 15, 2018

Study Completion

May 15, 2018

Last Updated

June 11, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations