Exploring How Exercise Frequency Impacts Muscle Resistance and Balance in Institutionalized Seniors
NCT ID: NCT07060729
Last Updated: 2025-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
46 participants
INTERVENTIONAL
2026-01-02
2026-06-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Impact of Brief Daily Functional Resistance Training on Lower Extremity Physical Performance
NCT06396247
Effectiveness of 8 Week Multicomponent Exercise Program in Older Adults With Frailty and Cognitive Impairment
NCT06440733
Feasibility and Effectiveness of Concurrent Exercise Training on Frail Older Adults Living in Nursing Homes
NCT06380127
Upper Versus Lower Body Resistance Exercise in Older Adults
NCT03831373
Effects of Different Moderate-intensity Exercise Methods on Health in the Elderly
NCT05207501
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Behavioral: 2 exercise sessions (2X)
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 (2X)
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: 3 exercise sessions (3X)
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)
Behavioral: 2 exercise sessions (3X)
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)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Behavioral: 2 exercise sessions (2X)
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)
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)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* 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)
65 Years
90 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Instituto Politécnico de Leiria
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Filipe Fernandes Rodrigues
Doctorate
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IPLEIRIA/59/2022
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.