NCT04606667

Brief Summary

Evaluate the results of the implementation of a multicomponent exercise program (16 weeks) for elder community dwelling population on their functionality (via cognitive, balance and mobility status).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2009

Typical duration 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

June 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
9.1 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 28, 2020

Completed
Last Updated

October 28, 2020

Status Verified

October 1, 2020

Enrollment Period

2 years

First QC Date

September 18, 2020

Last Update Submit

October 27, 2020

Conditions

Keywords

AgingCommunityExercise programPhysiotherapyFunctionality

Outcome Measures

Primary Outcomes (3)

  • Functional mobility change

    Timed Up and Go Test is a validated test that consists on a timed 3 meter defined circuit after getting up from a chair and sitting in it. The categories of achievement are three: less than 10 seconds "without compromise", corresponding to normal performance; between 10.01 and 20 seconds it is considered "slight impairment or normal time for frail elderly"; more than 20.01 seconds corresponds to a degree of "functional impairment" that requires a more detailed assessment.

    Baseline, 8 weeks, 16 weeks

  • Balance change

    Berg scale is a validated instrument to assess balance and the risk of falling associated with its loss. From 56 to 54 points, each point less is associated with a 3 to 4% increase in the risk of falling, from 54 to 46 a change in one point is associated with a 6 to 8% increase in the risk of falling, and below 36 points the risk of falling is very close to 100%, which allows the results to be divided into 4 balance categories: "Total balance problem" (≤36 points); "Serious balance problem" (37-45 points); "Moderate balance problem" (46-53 points) and "normal balance" (≥54 points).

    Baseline, 8 weeks, 16 weeks

  • Cognitive status change

    Mini mental exam scale is a validate instrument to assess the cognitive function and the detection of potential dementia. Individuals are classified into three categories: a score equal to or less than 18 points corresponds to "severe cognitive impairment"; from 19 to 23 points "moderate cognitive impairment" and 24 or more points "normal cognitive state. The literature states that for the diagnosis of dementia, the scale results must be cross-checked with schooling, however when the objective is not to diagnose dementia, but only to characterize and assess changes in cognitive status, the crossing of the scale results with schooling does not justified.

    Baseline, 8 weeks, 16 weeks

Study Arms (1)

Multi component program

EXPERIMENTAL

The intervention lasted 16 weeks, with the evaluations carried out at baseline, after 8 weeks and at the end. The multi-component exercise program took place in day centers or collective residences. It was supervised by physiotherapists. The classes took place 3 times a week, at the same hour and on alternate days, for 45-60 minutes, for a total of 48 sessions. The program consisted on a warm-up (5 min) with exercises and walking, a balance and strength training (35-40 min) with exercises repeated 3 times and held for 15 seconds flexibility / relaxation (5 to 10 mins) periods. The strength training is performed with the resistance of the body weight or accessible and low cost equipment, with two series of 10 to 15 repetitions, after maximum resistance was calculated. The flexibility and cooling training consists of 3 repetitions maintained for 15 seconds.

Other: Exercise Program

Interventions

Exercise program

Multi component program

Eligibility Criteria

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

You may qualify if:

  • be supported by day centers or collective residences linked to the "Project + City",
  • not having regular exercise habits,
  • ability to walk (with or without assistance).

You may not qualify if:

  • not being collaborative,
  • missing the classes three times.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escola Superior de Saúde

Vila Nova de Gaia, Porto District, 4405-678, Portugal

Location

Related Publications (14)

  • American College of Sports Medicine; Chodzko-Zajko WJ, Proctor DN, Fiatarone Singh MA, Minson CT, Nigg CR, Salem GJ, Skinner JS. American College of Sports Medicine position stand. Exercise and physical activity for older adults. Med Sci Sports Exerc. 2009 Jul;41(7):1510-30. doi: 10.1249/MSS.0b013e3181a0c95c.

    PMID: 19516148BACKGROUND
  • Boyle PA, Buchman AS, Wilson RS, Bienias JL, Bennett DA. Physical activity is associated with incident disability in community-based older persons. J Am Geriatr Soc. 2007 Feb;55(2):195-201. doi: 10.1111/j.1532-5415.2007.01038.x.

    PMID: 17302655BACKGROUND
  • Cadore EL, Rodriguez-Manas L, Sinclair A, Izquierdo M. Effects of different exercise interventions on risk of falls, gait ability, and balance in physically frail older adults: a systematic review. Rejuvenation Res. 2013 Apr;16(2):105-14. doi: 10.1089/rej.2012.1397.

    PMID: 23327448BACKGROUND
  • Gine-Garriga M, Roque-Figuls M, Coll-Planas L, Sitja-Rabert M, Salva A. Physical exercise interventions for improving performance-based measures of physical function in community-dwelling, frail older adults: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2014 Apr;95(4):753-769.e3. doi: 10.1016/j.apmr.2013.11.007. Epub 2013 Nov 27.

    PMID: 24291597BACKGROUND
  • Gschwind YJ, Kressig RW, Lacroix A, Muehlbauer T, Pfenninger B, Granacher U. A best practice fall prevention exercise program to improve balance, strength / power, and psychosocial health in older adults: study protocol for a randomized controlled trial. BMC Geriatr. 2013 Oct 9;13:105. doi: 10.1186/1471-2318-13-105.

    PMID: 24106864BACKGROUND
  • Sjosten NM, Salonoja M, Piirtola M, Vahlberg T, Isoaho R, Hyttinen H, Aarnio P, Kivela SL. A multifactorial fall prevention programme in home-dwelling elderly people: a randomized-controlled trial. Public Health. 2007 Apr;121(4):308-18. doi: 10.1016/j.puhe.2006.09.018. Epub 2007 Feb 22.

    PMID: 17320125BACKGROUND
  • Lee HC, Chang KC, Tsauo JY, Hung JW, Huang YC, Lin SI; Fall Prevention Initiatives in Taiwan (FPIT) Investigators. Effects of a multifactorial fall prevention program on fall incidence and physical function in community-dwelling older adults with risk of falls. Arch Phys Med Rehabil. 2013 Apr;94(4):606-15, 615.e1. doi: 10.1016/j.apmr.2012.11.037. Epub 2012 Dec 6.

    PMID: 23220343BACKGROUND
  • Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

    PMID: 1202204BACKGROUND
  • Guerreiro, MPSA, et al. Adaptação à população portuguesa da tradução do Mini Mental State Examination (MMSE). Revista Portuguesa de Neurologia, 1994, 1.9: 9-10.

    BACKGROUND
  • Berg KO, Wood-Dauphinee SL, Williams JI, Maki B. Measuring balance in the elderly: validation of an instrument. Can J Public Health. 1992 Jul-Aug;83 Suppl 2:S7-11.

    PMID: 1468055BACKGROUND
  • Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.

    PMID: 1991946BACKGROUND
  • Shumway-Cook A, Baldwin M, Polissar NL, Gruber W. Predicting the probability for falls in community-dwelling older adults. Phys Ther. 1997 Aug;77(8):812-9. doi: 10.1093/ptj/77.8.812.

    PMID: 9256869BACKGROUND
  • Bherer L, Erickson KI, Liu-Ambrose T. A review of the effects of physical activity and exercise on cognitive and brain functions in older adults. J Aging Res. 2013;2013:657508. doi: 10.1155/2013/657508. Epub 2013 Sep 11.

    PMID: 24102028BACKGROUND
  • Freiberger E, Menz HB, Abu-Omar K, Rutten A. Preventing falls in physically active community-dwelling older people: a comparison of two intervention techniques. Gerontology. 2007;53(5):298-305. doi: 10.1159/000103256. Epub 2007 May 29.

    PMID: 17536207BACKGROUND

MeSH Terms

Conditions

Mobility Limitation

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • José LA Sousa, PhD

    Instituto Piaget

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Quasi-experimental, test-retest, with one sample.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapy coordinator

Study Record Dates

First Submitted

September 18, 2020

First Posted

October 28, 2020

Study Start

June 1, 2009

Primary Completion

June 1, 2011

Study Completion

September 1, 2011

Last Updated

October 28, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations