NCT03443375

Brief Summary

The present study aimed at investigating the effects of two different resistance training protocols - nonperiodized (NP) and daily undulating periodization (DUP) - on hemodynamic, morphofunctional and cognitive parameters of robust older women. Methods: Forty-two older women were randomized allocated into one of the three experimental groups: NP, DUP, and control group (CG). Evaluations of the hemodynamic, morphofunctional and cognitive parameters occurred before, during and after six months. The exercise groups performed the program of exercise twice a week over 22 weeks. In NP, the two weekly sessions were based on 3 sets of 8-10 repetitions at a difficult intensity. However, in DUP, a power exercise session based on 3 sets of 8-10 repetitions at a moderate intensity was added in the first session of the week.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

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

January 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

11 months

First QC Date

February 8, 2018

Last Update Submit

February 16, 2018

Conditions

AgingPhysical ActivitySarcopeniaCognitive DeclineBlood PressurePhysical Disability

Keywords

Older adultsPhysical functionMuscle massShort-term memoryExecutive functionBlood PressureResistance trainingExercise trainingPeriodization

Outcome Measures

Primary Outcomes (1)

  • Changes in transfer capacity in seconds

    TUG performance

    6 months

Secondary Outcomes (4)

  • Changes in fat-free mass in kg

    6 months

  • Changes in overall cognitive capacity in points

    6 months

  • Changes in blood pressure in mmHg

    6 months

  • Changes in shor-term memory in points

    6 months

Study Arms (3)

Nonperiodized resistance training

EXPERIMENTAL

The Nonperiodized group performed was an intervention based on resistance exercise program with a constant intensity.

Other: Physical exercise

Daily undulating periodized

EXPERIMENTAL

The Daily undulating periodized program was an intervention based on daily alterations on exercise load. .

Other: Physical exercise

Control group

NO INTERVENTION

The control group remained their regular habits of life during all study period, without engaging in physical exercise programs.

Interventions

Physical exerciseOTHER

The interventions proposed in the present trial were based on a safe and well-established exercise training program

Daily undulating periodizedNonperiodized resistance training

Eligibility Criteria

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

You may qualify if:

  • Aged ≥60 years;
  • Female;
  • Not having been part of a systematic program of physical exercises in the last 6 months;
  • MEEM score \>19 points;
  • Kihon checklist score \>10 points;
  • Capacity to perform the basic and instrumental activities of daily living according to Katz and Pfeffer indexes;
  • Self-reported good memory;
  • Complete all measurements.

You may not qualify if:

  • Cardiovascular disease (i.e., acute myocardial infarction, stroke, peripheral arterial disease, and transient ischemic disease)
  • Metabolic disease (i.e., diabetes mellitus type I or II), pulmonary disease (i.e., emphysema)
  • Neurological and/or psychiatric disease (i.e., Parkinson's or Alzheimer's disease)
  • Skeletal muscle disorders
  • Comorbidities associated with greater risk of falls
  • Recent history of smoking or alcohol abuse
  • Hormone replacement therapy and/or psychotropic drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Coelho-Junior HJ, Goncalves IO, Camara NOS, Cenedeze MA, Bacurau RF, Asano RY, Santana J, Caperuto E, Uchida MC, Rodrigues B. Non-periodized and Daily Undulating Periodized Resistance Training on Blood Pressure of Older Women. Front Physiol. 2018 Nov 27;9:1525. doi: 10.3389/fphys.2018.01525. eCollection 2018.

    PMID: 30542289DERIVED

MeSH Terms

Conditions

Motor ActivitySarcopeniaCognitive Dysfunction

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr. Coelho-Junior

Study Record Dates

First Submitted

February 8, 2018

First Posted

February 23, 2018

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 23, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share