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Frequency of Treatment ProtocolNCT07060729

Exploring How Exercise Frequency Impacts Muscle Resistance and Balance in Institutionalized Seniors

A study testing Behavioral: 2 exercise sessions (2X) and Behavioral: 2 exercise sessions (3X) in people with Frequency of Treatment Protocol, run by Instituto Politécnico de Leiria at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The older population is the least likely to engage in regular physical activity and to meet international recommendations for performing 150 minutes of moderate-intensity physical activity per week. Read more about this study

Who is it for?
Ages 65 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Frequency of Treatment Protocol
What is being tested?
Behavioral: 2 exercise sessions (2X) and Behavioral: 2 exercise sessions (3X)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 sitePortugal
Study dates
2 Jan 2026to 2 Jun 2026
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 90 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 65 years to 90 years.
  • Apparently healthy and without medical contraindications to exercise.
  • Normal weight (BMI ≤ 24.99 kg/m2) or overweight (BMI > 25 ≤ 29.99 kg/m2)
  • Being institutionalized for more than 6 months.
  • Not having done any exercise regime for the last 6 months or any kind of structured sport activity.

Who cannot join

  • Before Enrollment:
  • High risk of cardiovascular disease (ACSM, 2021)
  • High blood pressure (≥ 140/90mmHg) in the pre-exercise evaluation (ESC, 2024)
  • High risk of fall (more than 1 fall over the last 6 months).
  • During the intervention:
  • Acquired injury.
Show all 10Show fewer
  • Acquired medical condition.
  • Related or not related fall during intervention.
  • Inability to perform 5 consecutive exercise sessions.
  • Exercise adherence below 75% of total sessions (n = 24 or n = 36)

Trial locations and contacts

1 site in 1 country.

Portugal1 site
  • Instituto Politécnico de Leiria

    Leiria, Leiria District, 2411-901

Other trials in Portugal

About this study

Official title: Exploring How Exercise Frequency Impacts Muscle Resistance and Balance in Institutionalized Seniors: Protocol for a Randomized Controlled Trial

The older population is the least likely to engage in regular physical activity and to meet international recommendations for performing 150 minutes of moderate-intensity physical activity per week. Additionally, older adults living in care institutions tend to have even lower levels of physical activity compared to those living in the community. This physical inactivity among institutionalized older adults carries harmful consequences, such as the loss of muscle mass and strength, both of which are associated with decreased balance and an increased risk of falling, an adverse event with personal, physical, economic, social, and potentially fatal implications. Although this situation is well described in the literature, little is known about whether increasing physical activity levels from near-optimal (almost 150 minutes of physical activity per week) to optimal (more than 150 minutes per week) can influence muscle strength and balance in institutionalized older adults, and thereby reduce the burden related to falls.

This type of research is essential, as weekly frequency may be a variable to consider in the prescription of physical exercise for this population. The American College of Sports Medicine (ACSM) recommends using the FITT principle (Frequency, Intensity, Type, and Time) to guide exercise prescription. By adjusting these factors, individuals can tailor workouts to their specific goals and fitness levels. While attention has been given to the type of training, its intensity, and its duration, it is important to recognize that total weekly volume may be a determining factor for improvements in components of physical fitness.

Considering that this population tends to be physically inactive, incorporating physical activity two or three times per week may lead to different outcomes. While exercising twice per week may seem suboptimal, as it does not meet international guidelines, engaging in physical activity three times per week may be the minimum necessary to observe positive effects on muscle strength and balance.

Read the detailed description

Ageing is a universal experience. However, the physical ageing process occurs differently across individuals. When individuals remain physically active throughout life, their levels of physical fitness tend to be higher compared to those with low or no engagement in physical activity. Nevertheless, the literature shows that the general population does not meet the international recommendation of 150 minutes of moderate-intensity physical activity per week, and that the proportion of physically inactive individuals is higher among the older population compared to adults or children.

Given this scenario, marked by a lack of physical activity and the gradual loss of muscle mass inherent to ageing, which is exacerbated by the absence of muscular and cardiovascular stimulation, there is an increased risk of adverse outcomes, such as falls. It is well documented in the literature that physically inactive ageing is more pronounced in older adults living in institutions compared to those who remain in the community. This may be because community-dwelling older adults typically engage in behaviors considered physically active, such as household chores, social and recreational activities outside the home, gardening, or do-it-yourself tasks that promote movement. Conversely, older adults in institutional care, who are typically institutionalized due to a lack of autonomy and independence, tend to experience an accelerated physical ageing process, given the general lack of opportunities for physical activity. In such settings, household chores are not typically performed, opportunities to leave the premises for social or recreational activities are limited, and access to gardening spaces is often unavailable. Thus, institutionalized older adults are more vulnerable to the effects of physical inactivity, which further increases dependency on others.

The literature consistently highlights the beneficial effects of physical activity on the quality of life of older adults, including those living in institutions. Reducing the risk of falling is essential, as such events may result in total dependence, such as becoming bedridden or reliant on a wheelchair, and often involve a longer and more demanding recovery, both physically and psychologically. Falls also incur various costs: individual (e.g., medication), public (e.g., medical treatments), and institutional (e.g., hiring additional staff). Furthermore, fear of engaging in physically active behaviors, such as walking, due to the potential risk of falling again, can further discourage movement. Understanding that physical activity can play a protective role, by reducing fall risk, increasing confidence in physical activity, and gradually promoting independence and autonomy, may yield benefits both for the individual and for all parties involved in the care of institutionalized older adults.

In terms of international recommendations, the World Health Organization (WHO) and the American College of Sports Medicine (ACSM) advise that individuals perform at least 150 minutes of moderate-intensity physical activity per week, preferably 30 minutes per day. Additionally, strength training is recommended at least twice per week, at moderate intensity, involving 8-10 exercises and 10-15 repetitions per set. Flexibility and balance training are also advised twice per week, with each stretch lasting 15-30 seconds and repeated 2-4 times per muscle group, using static, dynamic, passive, or active exercises. However, despite being labelled as "recommendations," these guidelines present several practical limitations for the institutionalized older population. First, they imply approximately 60-90 minutes of regular physical activity per day, a significantly high volume for a population that is, by nature, physically inactive. Second, transitioning from inactivity to 60-90 minutes of daily exercise may be too abrupt, especially in the absence of appropriate adaptation and progression, and may increase the risk of adverse events associated with existing metabolic or cardiovascular conditions. Third, according to the ACSM, institutionalized older adults already present with at least one (or more) cardiovascular risk factor, requiring more cautious approaches than those applied to community-dwelling older adults or younger individuals. Lastly, not all institutions have access to resistance or cardio machines, free weights, transport to fitness facilities, or supervised professional guidance, which may limit the implementation of the strength training recommended by the WHO and ACSM.

Given this context, physical activity prescription for this population requires a tailored methodology suited to the institutional setting, namely, through multicomponent exercise programs. These programs integrate various components of physical fitness, including cardiovascular endurance, muscular strength, balance, agility, and flexibility. Sessions typically last 45-60 minutes and are conducted at light to moderate intensity, individualized based on each participant's subjective perception of effort, thereby allowing for self-regulation of intensity according to individual capabilities. According to the FITT framework, three of the four principles (Intensity, Type, and Time) are thereby addressed, with Frequency remaining as the variable to be further explored.

The variable of frequency is considered essential, as it can be pragmatically adjusted for populations residing in institutional settings. Multicomponent programs have traditionally been implemented two or three times per week, with a rest interval of one to two days between sessions. This schedule facilitates a cycle of physical stimulation followed by recovery. Furthermore, participation in two or three sessions per week, each lasting 45-60 minutes, presents a noteworthy distinction: two sessions fall short of the 150-minute weekly recommendation, while three sessions slightly exceed this threshold. Nevertheless, participation in such programs two or three times per week has demonstrated significant benefits across multiple domains of physical fitness, including cardiovascular endurance, muscular strength, balance, and agility. Thus, even without strict compliance with existing recommendations, substantial benefits are evident. The aim of the present investigation is to determine whether increased frequency yields greater benefits in this population, and whether greater emphasis should be placed not on rigid thresholds (e.g., the 150-minute guideline), but rather on identifying the minimum effective dose required to transition physically inactive institutionalized older adults to an "active" status during the initial stages of engagement in a multicomponent exercise program. The findings may support professionals in tailoring interventions to increase muscle mass and reduce fall risk among institutionalized older adults.

Being tested
Behavioral: 2 exercise sessions (2X), Behavioral: 2 exercise sessions (3X)
Keywords
Institutionalization, Frequency, Exercise, Fall risk, Muscle strength
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral: 2 exercise sessions (2X)Behavioural

    The (1) control group (2X) will receive an exercise screening checklist and 24 group training sessions, 2 times per week during a 12-week period, based on International Exercise Recommendations in Older Adults (ICFSR; Izquierdo et al., 2021). These are the recommendations commonly used for older adults.

  • Behavioral: 2 exercise sessions (3X)Behavioural

    The (3) experimental group (3X) will receive an exercise screening checklist and 36 group training sessions, 3 times per week during a 12-week period, based on International Exercise Recommendations in Older Adults (ICFSR; Izquierdo et al., 2021). These are the recommendations commonly used for older adults. This additional session will increase weekly exercise volume compared to the control group, also being closer to complying to the WHO International Guidelines of weekly physical activity (Bull et al., 2020)

Study groups in NCT07060729
Study groupRoleWhat they receive
Behavioral: 2 exercise sessions (2X)Active comparatorThe (1) control group (2X) will receive an exercise screening checklist and 24 group training sessions, 2 times per week during a 12-week period, based on International Exercise Recommendations in Older Adults (ICFSR; Izquierdo et al., 2021). These are the recommendations commonly used for older adults.
Receives: Behavioral: Behavioral: 2 exercise sessions (2X)
Behavioral: 3 exercise sessions (3X)ExperimentalThe (3) experimental group (3X) will receive an exercise screening checklist and 36 group training sessions, 3 times per week during a 12-week period, based on International Exercise Recommendations in Older Adults (ICFSR; Izquierdo et al., 2021). These are the recommendations commonly used for older adults. This additional session will increase weekly exercise volume compared to the control group, also being closer to complying to the WHO International Guidelines of weekly physical activity (Bull et al., 2020)
Receives: Behavioral: Behavioral: 2 exercise sessions (3X)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Training sessions attendance rate

    Post-intervention weekly exercise frequency, objectively measured by the physiologist using an attendance sheet.

    Measured: Baseline and at week 13 (after 12 week of intervention)

Secondary outcomes (8)
  1. Waist measurement

    Waist measurement is determined by using the midpoint between the lowest rib and the top of the hip bone, then wrapping a measurement tape around the waist.

    Measured: Baseline and at week 13 (after 12 week of intervention)

  2. Height

    Height is determined by the vertical distance of the person from the base to the top using a stadiometer.

    Measured: Before intervention

  3. Weight

    Weight is determined by the body mass of a person on a calibrated scale.

    Measured: Baseline and at week 13 (after 12 week of intervention)

  4. Body Mass Index

    Body Mass Index is calculated by dividing weight in kilograms by the square of height in meters.

    Measured: Baseline and at week 13 (after 12 week of intervention)

  5. Balance and dynamic agility measured using the Timed Up and Go test

    Timed up and Go is measured by timing how long it takes a person to stand up from a chair, walk 2.44 meters, turn around, walk back to the chair, and sit down.

    Measured: Baseline and at week 13 (after 12 week of intervention)

  6. Upper body muscle resistance measured using the Arm curl test

    Arm curl test is measured by assessing how many bicep curls using a dumbbell (4-5 lbs for women, 8 lbs for men) a person can complete in 30 seconds

    Measured: Baseline and at week 13 (after 12 week of intervention)

  7. Lower body muscle resistance measured using the Chair sit and stand test

    Chair sit and stand test is measured by counting the number of sit-to-stand repetitions completed within 30 seconds.

    Measured: Baseline and at week 13 (after 12 week of intervention)

  8. Rate of Falls per participant

    Reported by the physiologists or by medical and nursing staff within the institution.

    Measured: Baseline and at week 13 (after 12 week of intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2025
  2. Study start2 Jan 2026
  3. Primary completion2 May 2026
  4. Study completion2 Jun 2026

Resources

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
Double blind
Who is masked
Participant, Care provider
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07060729
Sponsor's protocol ID
IPLEIRIA/59/2022
Status last verified
Oct 2026
First submitted
23 Jun 2025
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Primary and secondary data related to the study.

Publications

  • Rodrigues F, Izquierdo M, Monteiro D, Jacinto M, Matos R, Amaro N, Antunes R, Teixeira DS. Muscle Strength Matters Most for Risk of Falling Apart from Body Mass Index in Older Adults: A Mediated-Moderation Analysis. J Frailty Aging. 2024;13(4):427-431. doi: 10.14283/jfa.2024.68.

    PubMed 39574263
  • Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955.

    PubMed 33239350
  • Izquierdo M, Merchant RA, Morley JE, Anker SD, Aprahamian I, Arai H, Aubertin-Leheudre M, Bernabei R, Cadore EL, Cesari M, Chen LK, de Souto Barreto P, Duque G, Ferrucci L, Fielding RA, Garcia-Hermoso A, Gutierrez-Robledo LM, Harridge SDR, Kirk B, Kritchevsky S, Landi F, Lazarus N, Martin FC, Marzetti E, Pahor M, Ramirez-Velez R, Rodriguez-Manas L, Rolland Y, Ruiz JG, Theou O, Villareal DT, Waters DL, Won Won C, Woo J, Vellas B, Fiatarone Singh M. International Exercise Recommendations in Older Adults (ICFSR): Expert Consensus Guidelines. J Nutr Health Aging. 2021;25(7):824-853. doi: 10.1007/s12603-021-1665-8.

    PubMed 34409961
  • Mollinedo Cardalda I, Lopez A, Cancela Carral JM. The effects of different types of physical exercise on physical and cognitive function in frail institutionalized older adults with mild to moderate cognitive impairment. A randomized controlled trial. Arch Gerontol Geriatr. 2019 Jul-Aug;83:223-230. doi: 10.1016/j.archger.2019.05.003. Epub 2019 May 8.

    PubMed 31100545

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral: 2 exercise sessions (2X) and Behavioral: 2 exercise sessions (3X) in people with Frequency of Treatment Protocol, run by Instituto Politécnico de Leiria 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 10 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 16 Oct 2026. 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?

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?

Training sessions attendance rate (time frame: Baseline and at week 13 (after 12 week of intervention)). 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 NCT07060729, which also lists 4 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 16 Oct 2026.

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