NCT01874132

Brief Summary

Cardiovascular diseases (CVD) represent the most frequent cause of death among the elderly population. Hypertension, unfavorable lipid profile, obesity and physical inactivity are among the main risk factors for CVD. In contrast, mortality from CVD is inversely related to levels of physical activity, and is lower in individuals who exercise and have higher functional fitness levels. Thus, the Centers for Disease Control and Prevention, the American College of Sports Medicine, and the American Heart Association have recommended 20-30 min of moderate-to-vigorous aerobic training for the elderly, preferably every day or at least 3 days a week in the case of vigorous exercise.The same organizations also suggest the inclusion of resistance training in order to improve functional fitness. Therefore, the purpose of this study was to compare different exercise modalities in long-term changes of CVD risk factors and physical fitness among older adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 10, 2013

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

December 12, 2016

Completed
Last Updated

May 8, 2017

Status Verified

March 1, 2017

Enrollment Period

4 months

First QC Date

June 6, 2013

Results QC Date

October 18, 2016

Last Update Submit

March 24, 2017

Conditions

Keywords

ExerciseBlood pressureLipidsBody compositionFitnessBone densityQuality of life

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular Disease Risk Factors

    Descriptive frequency of the number of cardiovascular risk factors aggregated in each participant. The risk factors considered were: (i) hypertension; (ii) obesity; and (iii) dyslipidemia.

    one year

Secondary Outcomes (1)

  • Risk of Falls

    One year

Other Outcomes (1)

  • Quality of Life

    One year

Study Arms (3)

Aerobic exercise training

EXPERIMENTAL

Dose response

Behavioral: Exercise training

Aerobic and resistance exercise training

EXPERIMENTAL

Dose response

Behavioral: Exercise training

Control

NO INTERVENTION

Non-exercising control group

Interventions

Both training programs were of moderate-to-vigorous intensity, three days per week for nine months.

Also known as: Aerobic training, resistance training, Combined training, multicomponent training
Aerobic and resistance exercise trainingAerobic exercise training

Eligibility Criteria

Age65 Years - 79 Years
Sexmale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Older adults living independently;
  • medical approval.

You may not qualify if:

  • Non-smokers;
  • Non-morbidly obese;
  • No history of severe hypertension;
  • No history of falls;
  • No orthopaedic, neurological, pulmonary, or cardiac problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maia City Council facilities

Maia, 4470-384, Portugal

Location

Related Publications (7)

  • Sousa N, Mendes R, Oliveira J. Response to Drs. Safer and Safer. J Am Geriatr Soc. 2014 Mar;62(3):590-1. doi: 10.1111/jgs.12712. No abstract available.

    PMID: 24628645BACKGROUND
  • Sousa N, Mendes R, Abrantes C, Sampaio J, Oliveira J. Long-term effects of aerobic training versus combined aerobic and resistance training in modifying cardiovascular disease risk factors in healthy elderly men. Geriatr Gerontol Int. 2013 Oct;13(4):928-35. doi: 10.1111/ggi.12033. Epub 2013 Feb 26.

  • Sousa N, Mendes R, Abrantes C, Sampaio J, Oliveira J. A randomized 9-month study of blood pressure and body fat responses to aerobic training versus combined aerobic and resistance training in older men. Exp Gerontol. 2013 Aug;48(8):727-33. doi: 10.1016/j.exger.2013.04.008. Epub 2013 Apr 26.

  • Sousa N, Mendes R, Abrantes C, Sampaio J, Oliveira J. Is once-weekly resistance training enough to prevent sarcopenia? J Am Geriatr Soc. 2013 Aug;61(8):1423-4. doi: 10.1111/jgs.12387. No abstract available.

  • Sousa N, Mendes R, Abrantes C, Sampaio J, Oliveira J. Effectiveness of combined exercise training to improve functional fitness in older adults: A randomized controlled trial. Geriatr Gerontol Int. 2014 Oct;14(4):892-8. doi: 10.1111/ggi.12188. Epub 2014 Apr 30.

  • Sousa N, Mendes R, Abrantes C, Sampaio J, Oliveira J. A randomized study on lipids response to different exercise programs in overweight older men. Int J Sports Med. 2014 Dec;35(13):1106-11. doi: 10.1055/s-0034-1374639. Epub 2014 Jul 10.

  • Sousa N, Mendes R, Silva A, Oliveira J. Combined exercise is more effective than aerobic exercise in the improvement of fall risk factors: a randomized controlled trial in community-dwelling older men. Clin Rehabil. 2017 Apr;31(4):478-486. doi: 10.1177/0269215516655857. Epub 2016 Jul 10.

MeSH Terms

Conditions

OverweightObesityLipid Metabolism DisordersSarcopeniaOsteoporosisPersonal SatisfactionMotor Activity

Interventions

ExerciseResistance Training

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsMetabolic DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, Human

Results Point of Contact

Title
Professor Nelson Sousa
Organization
University of Trás-os-Montes e Alto Douro

Study Officials

  • Nelson Sousa, PhD

    Research Center in Sport Sciences, Health Sciences and Human Development; University of Trás-os-Montes e Alto Douro

    PRINCIPAL INVESTIGATOR
  • José Oliveira, PhD

    Research Center in Physical Activity, Health and Leisure; Sport Faculty, University of Porto

    STUDY DIRECTOR
  • Romeu Mendes, MD

    University of Trás-os-Montes and Alto Douro

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 6, 2013

First Posted

June 10, 2013

Study Start

May 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2014

Last Updated

May 8, 2017

Results First Posted

December 12, 2016

Record last verified: 2017-03

Locations