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

NCT07060729 | Not Yet Recruiting

• 1 other identifier: IPLEIRIA/59/2022
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Frequency of Treatment Protocol

Keywords

Institutionalization; Frequency; Exercise; Fall risk; Muscle strength

Outcome Measures

Primary Outcomes (1)

• Training sessions attendance rate

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

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

Secondary Outcomes (8)

• Waist measurement

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

• Height

  Before intervention

• Weight

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

• Body Mass Index

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

• Balance and dynamic agility measured using the Timed Up and Go test

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

Other Outcomes (3)

• Resting blood pressure (mmHg)

  Before training session

• Resting heart rate before exercise (bpm)

  Before training session

• Exercise intensity

  After 10, 30, and 60 minutes of each training session, and data reported will be light (1 point), moderate (2 points) or vigorous intensity (3 points).

Study Arms (2)

Behavioral: 2 exercise sessions (2X)

ACTIVE COMPARATOR

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: Behavioral: 2 exercise sessions (2X)

Behavioral: 3 exercise sessions (3X)

EXPERIMENTAL

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: Behavioral: 2 exercise sessions (3X)

Interventions

Behavioral: 2 exercise sessions (2X) BEHAVIORAL

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)

Behavioral: 2 exercise sessions (3X) BEHAVIORAL

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: 3 exercise sessions (3X)

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• Instituto Politécnico de Leiria: lead

Related Publications (4)

• 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.

  PMID: 39574263 BACKGROUND

• 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.

  PMID: 33239350 BACKGROUND

• 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.

  PMID: 34409961 BACKGROUND

• 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.

  PMID: 31100545 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctorate

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 11, 2025
• Study Start: January 2, 2026
• Primary Completion: May 2, 2026
• Study Completion (Estimated): June 2, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: After publication.
• Access Criteria: University teachers and reseachers.