Older Adults (65 Years and Older)NCT07006584
Gait Reeducation Program in Older Adults
A study testing Experimental and Active Comparator #1 in people with Older Adults (65 Years and Older) and Balance, run by Universidad Europea de Madrid at 1 site in Peru.
Trial summary
The sequential square mat (SSM) Fisior® program is a novel functional gait training tool designed to enhance motor control, coordination, and strength through guided step sequences on a visual-tactile platform. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Older Adults (65 Years and Older), Balance, Gait Disorders
- What is being tested?
- Experimental and Active Comparator #1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 sitePeru
- Study dates
- 15 Sep 2023to 31 Oct 2023
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- They where elegible if they were:
- 60 years or older.
- Not institutionalized.
- Scored 24 or higher on the Mini-Mental State Examination (MMSE), indicating no cognitive impairment.
- Could communicate effectively.
- Able to stand up and walk at least 10 meters unassisted
- Scored 60 or higher on the Barthel Index (indicating sufficient functional independence).
Who cannot join
- Furthermore, participants were excluded if they:
- Had a medical condition that contraindicated gait training and exhibited severe cognitive or behavioral impairments that would prevent them from completing the training program.
Trial locations and contacts
1 site in 1 country.
Peru1 site
Comprehensive Center for Older Adults (CIAM).
Lince, Lima region, 15073
About this study
Official title: Impact of a Functional Gait Training Program as a Complementary Strategy to Improve Physical Function in Older Adults
The sequential square mat (SSM) Fisior® program is a novel functional gait training tool designed to enhance motor control, coordination, and strength through guided step sequences on a visual-tactile platform. The objective of the present study is to evaluate the effects of incorporating the SSM Fisior® gait training program into routine physical activity workshops for older adults. Specifically, the study aims to assess its impact on skeletal muscle quantity, strength, and performance, as well as overall functional capacity, in a population of older adults attending a municipal community center (Centro Integral del Adulto Mayor, CIAM) in Lima, Peru.
Read the detailed description
The present study is a randomized was carried out with adults aged 60 years and older recruited from the Comprehensive Center for Older Adults (CIAM) in the Lince district of Lima, Peru. The study adhered to the ethical principles outlined in the Declaration of Helsinki, and its protocol (182-2023-CIEI-FMH-USMP) received approval from the Institutional Ethics Committee of the Faculty of Human Medicine at the University of San Martín de Porres (USMP), Lima, Peru.
Participants were eligible if they were 60 years or older, were not institutionalized, scored 24 or higher on the Mini-Mental State Examination (MMSE), indicating no cognitive impairment, could communicate effectively, were able to stand up and walk at least 10 meters unassisted, scored 60 or higher on the Barthel Index (indicating sufficient functional independence). Furthermore, participants were excluded if they had a medical condition that contraindicated gait training and exhibited severe cognitive or behavioral impairments that would prevent them from completing the training program.
A simple randomization process was used to assign participants to two groups: Group A and Group B. The randomization was performed using a computer-generated random number sequence with Microsoft Excel, and it was conducted after participant enrollment to ensure allocation concealment. Group A attended only the physical activity workshops offered by Centro Integral del Adulto Mayor (CIAM), consisting of one weekly class each of gymnastics, dance, swimming, and Tai Chi, held on different days of the week. Group B participated in the same workshops and additionally completed functional gait training using the SSM Fisior® program. The intervention period lasted 12 weeks for both groups, with 2 additional weeks allocated for baseline and post-intervention assessments (T1 and T2). All assessments and activities were carried out at the CIAM center in Lince (Lima, Peru), between October and December 2023.
- Conditions
- Older Adults (65 Years and Older), Balance, Gait Disorders, Physical Performance, Calf Muscle Weakness, Abdominal
- Being tested
- Experimental, Active Comparator #1
- Keywords
- Frailty, Aged, Mobility, Physical Performance, Healthy Aging, Physical Therapy
- Medical subject headings
- Mobility Limitation, Sarcopenia, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
Group B participated in the same workshops and additionally completed functional gait training using the SSM Fisior® program. The intervention period lasted 12 weeks for both groups, with 2 additional weeks allocated for baseline and post-intervention assessments (T1 and T2).
Active Comparator #1Other
Group A attended only the physical activity workshops offered by Centro Integral del Adulto Mayor (CIAM), consisting of one weekly class each of gymnastics, dance, swimming, and Tai Chi, held on different days of the week.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Physical activity workshops) | Active comparator | Group A attended only the physical activity workshops offered by Centro Integral del Adulto Mayor (CIAM), consisting of one weekly class each of gymnastics, dance, swimming, and Tai Chi, held on different days of the week. Receives: Other: Active Comparator #1 |
| Group B (Physical activity workshops+functional gait training with SSM Fisior® program) | Experimental | Group B participated in the same workshops and additionally completed functional gait training using the SSM Fisior® program. The intervention period lasted 12 weeks for both groups, with 2 additional weeks allocated for baseline and post-intervention assessments (T1 and T2). Receives: Other: Experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Performance
Several tools have been proposed to evaluate mobility and to assess it. In this study, physical performance was measured using the Short Physical Performance Battery (SPPB), which has been validated for use in older populations. This test includes three components: balance (foot together, semi-tandem, tandem), 4-meter gait speed, and chair stand test (standing and sitting five times). The SPPB scores each timed task based on predefined thresholds, resulting in a total score ranging from 0 (worst performance) to 12 (best performance).
The SPPB was designed to quickly identify the physical status of older adults by assessing lower limb functionality. Performance in these tests is strongly associated with mobility-related disability and serves as an independent predictor of short-term mortality and institutionalization. The medical community uses SPPB, among other tools, as a primary approach to detect and identifying frailty.
Measured: Baseline and Week 12
Secondary outcomes (6)
Gait Speed
Gait speed was assessed using the Timed Up and Go Test (Up\&Go), a fundamental mobility indicator. This test measures the time taken for a person to rise from a chair with armrests, walk 3 meters, return, and sit back down.
Measured: Baseline and Week 12
Calf Circumference
This standardized approach ensured reliability and accuracy in the calf circumference data, strengthening its role as a valid anthropometric marker for evaluating nutritional and functional health status in older adults.
Measured: Baseline and Week 12
Abdominal Circumference
Abdominal circumference (AC), also referred to as waist circumference, is an important anthropometric parameter commonly used to assess nutritional status and central adiposity. It is a well-established indicator of cardiometabolic risk, strongly associated with conditions such as cardiovascular and cerebrovascular disease.
In this study, AC was measured following standard anthropometric procedures, specifically 2.5 cm above the navel, using a non-elastic, flexible measuring tape. Participants were instructed to stand upright with feet shoulder-width apart, arms relaxed at their sides, and abdomen relaxed but not contracted. The measurement was taken at the end of a normal expiration to avoid variability caused by breathing.
All measurements were conducted by trained health professionals experienced in anthropometric assessment. Each measurement was taken twice; if the two values differed by more than 1.0 cm, a third measurement was performed.
Measured: Baseline and Week 12
SARC-F (Strength, Ambulation, Rising from a chair, Stair climbing and history of Falling)
SARC-F (Strength, Ambulation, Rising from a chair, Stair climbing and history of Falling) is a self-reported screening tool used in the sarcopenia diagnosis process that has been proposed and validated for various English-speaking and Latin populations. The test is based on the following questions: Ability to carry 4.5 kg; Need for assistance to cross a room; Ability to stand up from a chair; Ability to climb 10 steps; Number of falls in the past year. For the first four questions, the responses are scored as follows: None = 0, Some = 1, Much or Cannot = 2. For the fifth question, responses are scored as follows: None = 0, 1-3 falls = 1, 4 or more falls = 2. A SARC-F (Strength, Ambulation, Rising from a chair, Stair climbing and history of Falling) score > 4 indicates a positive risk for diagnosing sarcopenia.
Measured: Baseline and Week 12
Handgrip Strength
Dynamometry, or handgrip strength measurement, is used to assess the function and strength of the upper extremities. Handgrip strength was assessed using a Jamar hydraulic handheld dynamometer (Jamar, Sammons Preston, Bolingbrook, IL), a standard and validated tool for measuring isometric grip force. Each participant performed three trials with their dominant hand, with a 60-second rest between trials to prevent fatigue. Verbal encouragement was provided during each trial to ensure maximal effort. The highest value obtained from the three attempts was used for analysis. This method is widely recommended for evaluating overall muscle strength and functional capacity in older adults.
Measured: Baseline and Week 12
Functional Capacity: Barthel Index
The Barthel Index (BI) is considered one of the most suitable tools for identifying functional limitations that impact older adults' quality of life in home and community settings.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start15 Sep 2023
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Older Adults (65 Years and Older)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Bermejo Franco, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006584
- Sponsor's protocol ID
- 182-2023-CIEI-FMH-USMP
- Status last verified
- Jul 2025
- First submitted
- 27 May 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alegre-Tamariz J, Sanchez-Medina J, Runzer-Colmenares FM, Avila-Rodriguez C, Bermejo-Franco A, Parodi JF. Impact of a functional gait training program as a complementary strategy to improve physical function in older adults: a randomized clinical trial. BMC Geriatr. 2025 Oct 21;25(1):789. doi: 10.1186/s12877-025-06471-x.
PubMed 41120990
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Functional Gait Training Program as a Complementary Strategy to Improve Physical Function in Older Adults
- ClinicalTrials.gov ID
- NCT07006584
- Acronym / sponsor ID
- 182-2023-CIEI-FMH-USMP
- Conditions
- Older Adults (65 Years and Older), Balance, Gait Disorders, Physical Performance, Calf Muscle Weakness, Abdominal
- Keywords
- Frailty, Aged, Mobility, Physical Performance, Healthy Aging, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 5 Jun 2025 (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.
The sequential square mat (SSM) Fisior® program is a novel functional gait training tool designed to enhance motor control, coordination, and strength through guided step sequences on a visual-tactile platform. The objective of the present study is to evaluate the effects of incorporating the SSM Fisior® gait training program into routine physical activity workshops for older adults. Specifically, the study aims to assess its impact on skeletal muscle quantity, strength, and performance, as well as overall functional capacity, in a population of older adults attending a municipal community center (Centro Integral del Adulto Mayor, CIAM) in Lima, Peru.
Detailed description
The present study is a randomized was carried out with adults aged 60 years and older recruited from the Comprehensive Center for Older Adults (CIAM) in the Lince district of Lima, Peru. The study adhered to the ethical principles outlined in the Declaration of Helsinki, and its protocol (182-2023-CIEI-FMH-USMP) received approval from the Institutional Ethics Committee of the Faculty of Human Medicine at the University of San Martín de Porres (USMP), Lima, Peru.
Participants were eligible if they were 60 years or older, were not institutionalized, scored 24 or higher on the Mini-Mental State Examination (MMSE), indicating no cognitive impairment, could communicate effectively, were able to stand up and walk at least 10 meters unassisted, scored 60 or higher on the Barthel Index (indicating sufficient functional independence). Furthermore, participants were excluded if they had a medical condition that contraindicated gait training and exhibited severe cognitive or behavioral impairments that would prevent them from completing the training program.
A simple randomization process was used to assign participants to two groups: Group A and Group B. The randomization was performed using a computer-generated random number sequence with Microsoft Excel, and it was conducted after participant enrollment to ensure allocation concealment. Group A attended only the physical activity workshops offered by Centro Integral del Adulto Mayor (CIAM), consisting of one weekly class each of gymnastics, dance, swimming, and Tai Chi, held on different days of the week. Group B participated in the same workshops and additionally completed functional gait training using the SSM Fisior® program. The intervention period lasted 12 weeks for both groups, with 2 additional weeks allocated for baseline and post-intervention assessments (T1 and T2). All assessments and activities were carried out at the CIAM center in Lince (Lima, Peru), between October and December 2023.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Physical activity workshops) | Active comparator | Other: Active Comparator #1Group A attended only the physical activity workshops offered by Centro Integral del Adulto Mayor (CIAM), consisting of one weekly class each of gymnastics, dance, swimming, and Tai Chi, held on different days of the week. |
| Group B (Physical activity workshops+functional gait training with SSM Fisior® program) | Experimental | Other: ExperimentalGroup B participated in the same workshops and additionally completed functional gait training using the SSM Fisior® program. The intervention period lasted 12 weeks for both groups, with 2 additional weeks allocated for baseline and post-intervention assessments (T1 and T2). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 60 years or older.
- Not institutionalized.
- Scored 24 or higher on the Mini-Mental State Examination (MMSE), indicating no cognitive impairment.
- Could communicate effectively.
- Able to stand up and walk at least 10 meters unassisted
Key exclusion criteria (2 listed)
- Had a medical condition that contraindicated gait training and exhibited severe cognitive or behavioral impairments that would prevent them from completing the training program.
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 |
|---|---|---|
| ExperimentalGroup B participated in the same workshops and additionally completed functional gait training using the SSM Fisior® program. The intervention period lasted 12 weeks for both groups, with 2 additional weeks allocated for baseline and post-intervention assessments (T1 and T2). | Other | Group B (Physical activity workshops+functional gait training with SSM Fisior® program) |
| Active Comparator #1Group A attended only the physical activity workshops offered by Centro Integral del Adulto Mayor (CIAM), consisting of one weekly class each of gymnastics, dance, swimming, and Tai Chi, held on different days of the week. | Other | Group A (Physical activity workshops) |
Primary outcome
Physical Performance
Time frame: Baseline and Week 12
Several tools have been proposed to evaluate mobility and to assess it. In this study, physical performance was measured using the Short Physical Performance Battery (SPPB), which has been validated for use in older populations. This test includes three components: balance (foot together, semi-tandem, tandem), 4-meter gait speed, and chair stand test (standing and sitting five times). The SPPB scores each timed task based on predefined thresholds, resulting in a total score ranging from 0 (worst performance) to 12 (best performance). The SPPB was designed to quickly identify the physical status of older adults by assessing lower limb functionality. Performance in these tests is strongly associated with mobility-related disability and serves as an independent predictor of short-term mortality and institutionalization. The medical community uses SPPB, among other tools, as a primary approach to detect and identifying frailty.
6 secondary outcomes
Gait Speed
Time frame: Baseline and Week 12
Calf Circumference
Time frame: Baseline and Week 12
Abdominal Circumference
Time frame: Baseline and Week 12
SARC-F (Strength, Ambulation, Rising from a chair, Stair climbing and history of Falling)
Time frame: Baseline and Week 12
Handgrip Strength
Time frame: Baseline and Week 12
Functional Capacity: Barthel Index
Time frame: Baseline and Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Derived from this study: PubMed 41120990Alegre-Tamariz J, Sanchez-Medina J, Runzer-Colmenares FM, Avila-Rodriguez C, Bermejo-Franco A, Parodi JF. Impact of a functional gait training program as a complementary strategy to improve physical function in older adults: a randomized clinical trial. BMC Geriatr. 2025 Oct 21;25(1):789. doi: 10.1186/s12877-025-06471-x.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental and Active Comparator #1 in people with Older Adults (65 Years and Older) and Balance, run by Universidad Europea de Madrid at 1 site in Peru.
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 7 inclusion and 2 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: finished, as of the sponsor's last update on 24 Jul 2025. 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 Peru. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Physical Performance (time frame: Baseline and Week 12). 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 NCT07006584, which also lists 1 linked publication.
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 24 Jul 2025; AzTrials last refreshed its copy on 29 Oct 2026.