NCT03381976

Brief Summary

This study compared different frequency low-volume resistance training (RT) on total, android, gynoid and trunk body fat in obese older women

Trial Health

100
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable obesity

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

March 2, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2015

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2015

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 22, 2017

Completed
Last Updated

December 22, 2017

Status Verified

December 1, 2017

Enrollment Period

4 months

First QC Date

December 18, 2017

Last Update Submit

December 21, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in body composition

    Whole-body dual-energy X-ray absorptiometry (DXA) scans (Lunar Prodigy, model NRL 41990, GE Lunar, Madison, WI) were used to assess total body fat, trunk fat, gynoid fat and android fat. Prior to scanning, participants were instructed to remove all objects containing metal. Scans were performed with the subjects lying in the supine position along the table's longitudinal centerline axis. Feet were taped together at the toes to immobilize the legs while the hands were maintained in a pronated position within the scanning region. Both calibration and analysis were carried out by a skilled laboratory technician. Equipment calibration followed the manufacturer's recommendations. The software generated standard lines that set apart the limbs from the trunk and head. These lines were adjusted by the same technician using specific anatomical points determined by the manufacturer. The results are presented in kilograms (kg)

    baseline and 12 weeks

  • Change in fat z-score

    A composite z-score, was calculated using the following formula: (total body fat z-score) + (gynoid body fat z-score) + (android fat z-score) / 3. Z-scores were obtained from the DXA using standard software.

    baseline and 12 weeks

Secondary Outcomes (3)

  • Changes in Anthropometry Parameters

    baseline and 12 weeks

  • Changes in Dietary intake

    baseline and 12 weeks

  • Changes in Total Strength

    baseline and 12 weeks

Study Arms (3)

Intervention 2X/week (G2X)

ACTIVE COMPARATOR

This group performed resistance training twice a week (Tuesdays and Thursdays)

Other: Intervention 2X/week (G2X)

Intervention 3X/week (G3X)

ACTIVE COMPARATOR

This group performed resistance training three sessions a week (Mondays, Wednesdays, and Fridays).

Other: Intervention 3X/week (G3X)

Control group (GC)

NO INTERVENTION

This group did not perform any type of organized physical exercise during the study period.

Interventions

Participants performed resistance training (RT) composed of eight exercises performed for one set of 10-15 repetition maximum (RM). The rest interval between exercises was 2-3 min. Participants were instructed to control the speed of movement in the ratio of 1:2 for concentric and eccentric muscle actions, respectively. The progression of training loads in each exercise occurred, when a participant completed 15 repetitions in two consecutive sessions, with increases of 2-5% in exercises for the upper limbs, and 5-10% in exercises for the lower limbs. At the end of each session, one static stretching exercise at the point of discomfort for 15 seconds was performed for all major muscle groups for a total of exercises. Participants were asked not to perform any other type of organized physical exercise during the entire study period.

Intervention 2X/week (G2X)

Participants performed resistance training (RT) composed of eight exercises performed for one set of 10-15 repetition maximum (RM). The rest interval between exercises was 2-3 min. Participants were instructed to control the speed of movement in the ratio of 1:2 for concentric and eccentric muscle actions, respectively. The progression of training loads in each exercise occurred, when a participant completed 15 repetitions in two consecutive sessions, with increases of 2-5% in exercises for the upper limbs, and 5-10% in exercises for the lower limbs. At the end of each session, one static stretching exercise at the point of discomfort for 15 seconds was performed for all major muscle groups for a total of exercises. Participants were asked not to perform any other type of organized physical exercise during the entire study period.

Intervention 3X/week (G3X)

Eligibility Criteria

Age60 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older;
  • relative body fat ≥ 32 assessed by whole body dual-energy X-ray absorptiometry (DXA);
  • physically independent;
  • free from cardiac or orthopedic dysfunction that would have precluded them from performing the tests or the training program associated with the study;
  • not receiving hormonal replacement therapy;
  • not performing physical exercise more than once a week in the six months preceding the beginning of the investigation.

You may not qualify if:

  • All subjects not participating in 85% of the total sessions of training or withdrawl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

December 18, 2017

First Posted

December 22, 2017

Study Start

March 2, 2015

Primary Completion

July 6, 2015

Study Completion

July 24, 2015

Last Updated

December 22, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share