NCT03320005

Brief Summary

This comes from a non-randomized clinical trial, which aims to check on elderly women the effects of a program of resistance training (TR) in physical performance, in respiratory functional capacity, on health and quality of life.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Status
unknown

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

January 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 24, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

October 24, 2017

Status Verified

October 1, 2017

Enrollment Period

11 months

First QC Date

August 7, 2017

Last Update Submit

October 19, 2017

Conditions

Aging Disorder

Keywords

respiratory performancequality of lifephysical performance

Outcome Measures

Primary Outcomes (1)

  • Physical performance

    distance traveled on ISWT

    Change from Baseline at 24 weeks

Secondary Outcomes (3)

  • quality of life

    Change from Baseline at 24 weeks

  • respiratory muscle strength

    Change from Baseline at 24 weeks

  • Hand grip

    Change from Baseline at 24 weeks

Study Arms (2)

ResistanceTraining Group

ACTIVE COMPARATOR

The RT program has the following features: 05 classes performing two weekly sessions; day shift; sessions with maximum duration of 1 (one) hour; 02 series; 08 to 12 repetitions; interval between sets of 01 to 02 minutes; exercises: bench press, seated leg press 45°, pull forward, Earth, rowing standing calf standing, power lifting, abdominal and development.

Other: Resistance training group

Non training group

NO INTERVENTION

sedentary elderly

Interventions

Resistance training groupOTHER

Resistive exercises for legs and arms

ResistanceTraining Group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • year old or more
  • Do not have cardiac or respiratory diseases
  • neurological, Musculoskeletal and other diseases preventing the practice of exercises
  • not being a smoker; agree to participate in the study and signed an informed consent (IC); in the last six months preceding the evaluation did not have participated in physical activity program with the aim of improving physical performance.

You may not qualify if:

  • Difficult to complete the tasks
  • Acute diseases
  • Refuse to continue the program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Dirceu Costa, PhD

    Nove de Julho University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 7, 2017

First Posted

October 24, 2017

Study Start

January 1, 2017

Primary Completion

December 1, 2017

Study Completion

January 1, 2018

Last Updated

October 24, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share