NCT02143674

Brief Summary

Introduction: The life expectancy and the number of people hitting the old age have increased in recent years. The aging process is accompanied by morphological and functional changes that contribute to reduced functional capacity, increase the number of falls and the appearance of physical limitations. Exercise promotes maintenance of functional autonomy, improving the physical ability of the elderly making it more independent. Objective: To evaluate the effect of a program of muscle strengthening exercises associated with global stretching on balance, fear of falling and functional capacity in elderly women. Methods: This was a non-randomized controlled trial, in which 12 volunteers aged over 60 years were divided into two groups: intervention group (IG, n = 7) submitted to muscle strengthening exercises and stretching, 2 times per week for 12 weeks, and the control group (CG, n = 5), not submitted to the protocol but were educated about physical exercises. Before and after the protocol were evaluated scores of Berg Balance Scale, the Falls Efficacy Scale International (FES-I) and Evaluation of Functional Autonomy Development Group for Latin American Maturity (GDLAM). Data were statistically analyzed within and between groups with a significance level of p \<0.05.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

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

Study Start

First participant enrolled

September 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 21, 2014

Completed
Last Updated

May 21, 2014

Status Verified

May 1, 2014

Enrollment Period

2 months

First QC Date

February 27, 2014

Last Update Submit

May 20, 2014

Conditions

OsteoporosisSenile Osteopenia

Keywords

Stretching exercise muscleElderlyTechniques and exercisePhysiotherapy

Outcome Measures

Primary Outcomes (1)

  • balance score

    Berg Balance Scale (BBS)

    12 weeks

Secondary Outcomes (2)

  • Fear of falling score

    12 weeks

  • Functional Capacity

    12 weeks

Study Arms (2)

INTERVENTION

EXPERIMENTAL

Muscle stretching and Strength Training

Other: Muscle stretching and Strength Training

Educated about physical exercises

EXPERIMENTAL
Other: Educated about physical exercises

Interventions

Muscle stretching and Strength TrainingOTHER

Each step of stretching on specific muscles was repeated three times by keeping the posture for 30 seconds, (Arnold and Kokkonen, 2007; Toraman A, Yildirim. 2010; Dai, Ware, Giuliani, 2012; Duque et al., 2013; Granacher et al., 2013). The Pectoral, Quadriceps, Paraspinal, Abdominal and Ischial tibial and sural triceps muscles were elongated. Strength Training Muscle strengthening was performed using weights and dumbbells. The training load individually determined through the test of strength with 10 repetitions maximum. The load was reevaluated four weeks of training. The Abdominal, Paraspinal, Quadriceps and Posterior thigh muscles (hamstrings) were submitted to the intervention protocol.

INTERVENTION
Educated about physical exercisesOTHER
Educated about physical exercises

Eligibility Criteria

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

You may qualify if:

  • women aged over 60 years,
  • independent in locomotion,
  • with ability to understand verbal commands to perform the tests and participation in the treatment program

You may not qualify if:

  • execution of other physical activities or doing other types of physical therapy,
  • had any prior neurological deficit (stroke, traumatic brain injury, Parkinson's disease) or
  • musculoskeletal diseases which compromising performance and mobility,
  • use of orthosis for locomotion,
  • inability to perform the evaluation tests and/or participation in the intervention session

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Kinesiotherapy and Manual Therapeutic Resources, Department of Physical Therapy, Federal University of Pernambuco (UFPE)

Recife, Pernambuco, 50670-901, Brazil

Location

MeSH Terms

Conditions

OsteoporosisMotor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 27, 2014

First Posted

May 21, 2014

Study Start

September 1, 2012

Primary Completion

November 1, 2012

Study Completion

January 1, 2014

Last Updated

May 21, 2014

Record last verified: 2014-05

Locations

BR(1)