NCT05937009

Brief Summary

This study aims to determine the effects of an orientation exercise program addressed to old on physical-motor, cognitive, and affective competencies. This quasi-experimental study is a controlled trial involving an orientation exercise program. The program will run for 12 weeks (3 sessions per week). Participants will be clustered into two groups: the experimental group will perform the exercise orientation sessions, and the control group will maintain regular activities routines. Evaluations will be performed before and after the intervention. After the study is finished, the control group will attend a similar exercise program.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

June 22, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

December 5, 2023

Status Verified

July 1, 2023

Enrollment Period

Same day

First QC Date

June 22, 2023

Last Update Submit

December 3, 2023

Conditions

Outcome Measures

Primary Outcomes (8)

  • Change from the beginning, between groups comparison, in physical competencies

    Fullerton Advance Balance Scale to assess balance, ranging from 0 (worst) to 40 (best) points

    0, 12 weeks

  • Change from the beginning, between groups comparison, in physical competencies

    Senior Fitness Test, 6 minutes walking to assess aerobic capacity, measure in meters

    0, 12 weeks

  • Change from the beginning, between groups comparison, in physical competencies

    Senior Fitness Test, Sit and Stand to assess limb strength, measure by the number of repetitions

    0, 12 weeks

  • Change from the beginning, between groups comparison, in physical competencies

    Soda Pop Test to assess motor coordination.

    0, 12 weeks

  • Change from the beginning, between groups comparison, in cognitive competencies

    Trail Making Test (Part A and B) to assess processing speed and executive functioning, measure in seconds

    0, 12 weeks

  • Change from the beginning, between groups comparison, in cognitive competencies

    Rey Auditory Verbal Test to assess memory, measure in seconds

    0, 12 weeks

  • Change from the beginning, between groups comparison, in affective competencies

    Profile of Mood States to assess mood states, ranging from -32 (best) to 200 (worst) points

    0, 12 weeks

  • Change from the beginning, between groups comparison, in affective competencies

    Geriatric Depression Scale to assess depression state, ranging from 0 (best) to 30 (worst) points

    0, 12 weeks

Secondary Outcomes (1)

  • Cognitive impairment

    0 weeks

Study Arms (2)

Experimental: Experimental Orienteering group program

EXPERIMENTAL

The experimental group intervention will attend the orienteering program. The program integrates 3 sessions / week during 12 consecutive weeks.

Other: Orienteering exercise program

The control group

NO INTERVENTION

The control group will maintain the usually daily activities, not attending any exercise program. After study end, the control group will have the opportunity to participate on an exercise program.

Interventions

Orienteering exercise program running for 12 weeks (30-45 minutes, 3 sessions/week). Sessions will have 4 phases: 1) Signature of attendance sheet; 2) warm-up exercises for 5 minutes; 3) Start of orienteering proofs, where the departs will occur individually, with 3 interval minutes between participants; 4) stretches session, to return to a calm state.

Experimental: Experimental Orienteering group program

Eligibility Criteria

Age65 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged 65-75 years old;
  • Locomotor independent capacity;
  • Independent living in the community;
  • Historical of physical activity practice;
  • Attended, at least, the 3º school grade.

You may not qualify if:

  • Cognitive impairment such \< 15 points in Mini-Mental State Examination (MMSE);
  • Evidence of neuromuscular disturb;
  • Use of medication that conditions the performance of the orientation exercise tasks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade de Évora

Evora, Portugal

Location

Related Publications (6)

  • Bliss ES, Wong RH, Howe PR, Mills DE. Benefits of exercise training on cerebrovascular and cognitive function in ageing. J Cereb Blood Flow Metab. 2021 Mar;41(3):447-470. doi: 10.1177/0271678X20957807. Epub 2020 Sep 20.

    PMID: 32954902BACKGROUND
  • Eckstrom E, Neukam S, Kalin L, Wright J. Physical Activity and Healthy Aging. Clin Geriatr Med. 2020 Nov;36(4):671-683. doi: 10.1016/j.cger.2020.06.009. Epub 2020 Aug 19.

    PMID: 33010902BACKGROUND
  • Hemmeter UM, Ngamsri T. [Physical Activity and Mental Health in the Elderly]. Praxis (Bern 1994). 2022;110(4):193-198. doi: 10.1024/1661-8157/a003853. German.

    PMID: 35291872BACKGROUND
  • McCarthy, I., Suzuki, T., Tyler, N. & Holloway, C. (2016). Mobility in the built environment: Age-related changes in gait characteristics when walking on complex terrain. Healthy Aging Research, 5:10.

    BACKGROUND
  • Ostlund-Lagerstrom L, Blomberg K, Algilani S, Schoultz M, Kihlgren A, Brummer RJ, Schoultz I. Senior orienteering athletes as a model of healthy aging: a mixed-method approach. BMC Geriatr. 2015 Jul 8;15:76. doi: 10.1186/s12877-015-0072-6.

    PMID: 26152308BACKGROUND
  • Thomas E, Battaglia G, Patti A, Brusa J, Leonardi V, Palma A, Bellafiore M. Physical activity programs for balance and fall prevention in elderly: A systematic review. Medicine (Baltimore). 2019 Jul;98(27):e16218. doi: 10.1097/MD.0000000000016218.

    PMID: 31277132BACKGROUND

Study Officials

  • Catarina Pereira, Doctoral degree

    University of Évora

    PRINCIPAL INVESTIGATOR
  • José Marmeleira, Doctoral degree

    University of Évora

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 22, 2023

First Posted

July 10, 2023

Study Start

July 1, 2023

Primary Completion

July 1, 2023

Study Completion

January 1, 2024

Last Updated

December 5, 2023

Record last verified: 2023-07

Locations