Community-dwelling Older AdultsNCT05937009
12 Weeks Orienteering Program Exercise on Older Adults
A study testing Orienteering exercise program in people with Community-dwelling Older Adults, run by University of Évora at 1 site in Portugal.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Community-dwelling Older Adults
- What is being tested?
- Orienteering exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jul 2023to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Orientation Exercise Program on Older Adults, Motor Skills, Cognitive and Emotional State: a Pilot Study
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.
Read the detailed description
The aging process is lived for all and is associated with uncountable limitations, such as physical, psychological, cognitive, or emotional, that daily translate into difficulty in accomplishing normal activities (2). Simple tasks such as getting up and sitting, carrying a shopping bag, or climbing some stairs, start being seen as an obstacle, much because of aging and the associated decline in physical and cognitive competencies such as balance, limb strength, aerobic capacity, motor coordination, processing speed, memory, executive functioning and, consequently, affective competences, such as emotional states and depression may also be compromised (1).
Despite the above, it is known that there are some ways and alternatives that, even not reversing the aging process, might delay it, promoting healthy aging (6). Scientific advances recommend regular physical exercise since exercise ensures a more active lifestyle and, therefore, a less dependent on others' life. There are many options that physical exercise professionals can choose for planning physical exercise programs for older people (3).
Nonetheless, instead of exercise planning training prescription, other options can be used to achieve healthy aging. In alternative to traditional exercise training, sporting modalities, such as orientation, may benefit this population.
According to a study, after applying a protocol that included changes to the terrain to improve older adults' balance, there were significant improvements in their stride time (4).
Other studies done within the same area, which applied one questionnaire on functional well-being, and four scales on depression, gastrointestinal system, physical activity, and healthy index to senior athletes between the ages of 67 and 71, found significant improvements in all the referred parameters except for the depression scale where the control group made up of older adults who do not practice the modality showed better results (5).
However, the literature is scarce concerning the participation in orientation programs by the elderly population, namely in terms of this program's effect on aerobic capacity, lower limb strength, motor coordination, processing speed, memory, and executive functioning.
- Conditions
- Community-dwelling Older Adults
- Being tested
- Orienteering exercise program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orienteering exercise programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 0, 12 weeks
Change from the beginning, between groups comparison, in physical competencies
Soda Pop Test to assess motor coordination.
Measured: 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
Measured: 0, 12 weeks
Change from the beginning, between groups comparison, in cognitive competencies
Rey Auditory Verbal Test to assess memory, measure in seconds
Measured: 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
Measured: 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
Measured: 0, 12 weeks
Secondary outcomes (1)
Cognitive impairment
Mini-Mental State Examination, ranging from 0 (worst) to 30 (best) points
Measured: 0 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start1 Jul 2023
- Primary completion1 Jul 2023
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Community-dwelling Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Évora
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franclim Martins, University of Évora
- Investigators
- Catarina Pereira, Doctoral degree, Principal investigator, University of ÉvoraJosé Marmeleira, Doctoral degree, Principal investigator, University of Évora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937009
- Sponsor's protocol ID
- Franclim Martins
- Status last verified
- Jul 2023
- First submitted
- 22 Jun 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32954902Eckstrom 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.
PubMed 33010902Hemmeter 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.
PubMed 35291872McCarthy, 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.
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.
PubMed 26152308Thomas 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.
PubMed 31277132
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Orientation Exercise Program on Older Adults, Motor Skills, Cognitive and Emotional State: a Pilot Study
- ClinicalTrials.gov ID
- NCT05937009
- Acronym / sponsor ID
- Franclim Martins
- Conditions
- Community-dwelling Older Adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University of ÉvoraUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aging process is lived for all and is associated with uncountable limitations, such as physical, psychological, cognitive, or emotional, that daily translate into difficulty in accomplishing normal activities (2). Simple tasks such as getting up and sitting, carrying a shopping bag, or climbing some stairs, start being seen as an obstacle, much because of aging and the associated decline in physical and cognitive competencies such as balance, limb strength, aerobic capacity, motor coordination, processing speed, memory, executive functioning and, consequently, affective competences, such as emotional states and depression may also be compromised (1).
Despite the above, it is known that there are some ways and alternatives that, even not reversing the aging process, might delay it, promoting healthy aging (6). Scientific advances recommend regular physical exercise since exercise ensures a more active lifestyle and, therefore, a less dependent on others' life. There are many options that physical exercise professionals can choose for planning physical exercise programs for older people (3).
Nonetheless, instead of exercise planning training prescription, other options can be used to achieve healthy aging. In alternative to traditional exercise training, sporting modalities, such as orientation, may benefit this population.
According to a study, after applying a protocol that included changes to the terrain to improve older adults' balance, there were significant improvements in their stride time (4).
Other studies done within the same area, which applied one questionnaire on functional well-being, and four scales on depression, gastrointestinal system, physical activity, and healthy index to senior athletes between the ages of 67 and 71, found significant improvements in all the referred parameters except for the depression scale where the control group made up of older adults who do not practice the modality showed better results (5).
However, the literature is scarce concerning the participation in orientation programs by the elderly population, namely in terms of this program's effect on aerobic capacity, lower limb strength, motor coordination, processing speed, memory, and executive functioning.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Experimental Orienteering group program | Experimental | Other: Orienteering exercise programThe experimental group intervention will attend the orienteering program. The program integrates 3 sessions / week during 12 consecutive weeks. |
| 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. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orienteering exercise programOrienteering 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. | Other | Experimental: Experimental Orienteering group program |
Primary outcome
Change from the beginning, between groups comparison, in physical competencies
Time frame: 0, 12 weeks
Fullerton Advance Balance Scale to assess balance, ranging from 0 (worst) to 40 (best) points
Change from the beginning, between groups comparison, in physical competencies
Time frame: 0, 12 weeks
Senior Fitness Test, 6 minutes walking to assess aerobic capacity, measure in meters
Change from the beginning, between groups comparison, in physical competencies
Time frame: 0, 12 weeks
Senior Fitness Test, Sit and Stand to assess limb strength, measure by the number of repetitions
Change from the beginning, between groups comparison, in physical competencies
Time frame: 0, 12 weeks
Soda Pop Test to assess motor coordination.
Change from the beginning, between groups comparison, in cognitive competencies
Time frame: 0, 12 weeks
Trail Making Test (Part A and B) to assess processing speed and executive functioning, measure in seconds
Change from the beginning, between groups comparison, in cognitive competencies
Time frame: 0, 12 weeks
Rey Auditory Verbal Test to assess memory, measure in seconds
Change from the beginning, between groups comparison, in affective competencies
Time frame: 0, 12 weeks
Profile of Mood States to assess mood states, ranging from -32 (best) to 200 (worst) points
Change from the beginning, between groups comparison, in affective competencies
Time frame: 0, 12 weeks
Geriatric Depression Scale to assess depression state, ranging from 0 (best) to 30 (worst) points
1 secondary outcome
Cognitive impairment
Time frame: 0 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Background: PubMed 32954902Bliss 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.
- Background: PubMed 33010902Eckstrom 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.
- Background: PubMed 35291872Hemmeter 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.
- BackgroundMcCarthy, 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: PubMed 26152308Ostlund-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.
- Background: PubMed 31277132Thomas 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catarina Pereira, Doctoral degree principal investigator
University of Évora
José Marmeleira, Doctoral degree principal investigator
University of Évora
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orienteering exercise program in people with Community-dwelling Older Adults, run by University of Évora at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from the beginning, between groups comparison, in physical competencies (time frame: 0, 12 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05937009, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.