Frailty, Dementia
Conditions
Keywords
Exercise, Frailty, Nursing homes, Multicomponent exercise, Falls, Cognitive function, Physical performance
Brief summary
Can a multicomponent exercise program significantly improve physical and cognitive function and reduce fall rates among nursing home residents? To address this question, the present study aims to compare the effectiveness of a multicomponent exercise program with a stretching and relaxation program in nursing home residents.
Detailed description
Individuals residing in nursing homes commonly present with physical frailty and/or cognitive impairment. These geriatric syndromes are strongly associated with accelerated functional and cognitive decline, increased dependency, elevated fall risk, higher rates of hospitalization, and increased mortality. Accordingly, long-term care settings require evidence-based interventions capable of preserving functional capacity and cognitive performance while reducing fall incidence. Non-pharmacological approaches, particularly multicomponent exercise training, have demonstrated beneficial effects on physical and cognitive outcomes in institutionalized older adults. Nevertheless, existing evidence remains limited by methodological heterogeneity, underscoring the need for confirmation through rigorously designed randomized controlled trials. Therefore, this study proposes a 12-week randomized controlled trial in older adults living in nursing homes to evaluate the efficacy of a multicomponent exercise training program incorporating resistance and power, balance, and aerobic components on physical function, cognitive performance, and fall prevention. The primary objective is to determine whether a multicomponent exercise program produces greater improvements in physical and cognitive function and larger reductions in fall rates compared with a stretching and relaxation program used as an active control. Secondary objectives are to assess whether intervention effects are sustained six weeks following program cessation and to examine the moderating influence of specific subgroups, including frail older adults and individuals with dementia, on intervention-related outcomes. This study will be conducted as a 12-week assessor-blinded randomized controlled trial with a six-week post-intervention follow-up in nursing homes located in Vila Nova de Gaia, Porto District, Portugal. Participants will be randomly allocated to either a multicomponent exercise training group or an active control group. The intervention group will engage in supervised multicomponent exercise training twice weekly on nonconsecutive days to mitigate fatigue and overtraining. Each session will last 50 to 60 minutes and will comprise a standardized warm-up, progressive resistance and power exercises integrated with aerobic and balance training, followed by a cool-down period consisting of stretching and flexibility exercises. The exercise protocol will be aligned with the Global Consensus on Optimal Exercise recommendations for promoting healthy longevity in older adults. The active control group will participate in stretching, relaxation, and deep-breathing exercises, as well as low-intensity seated physical activities. Outcome assessments will be conducted at baseline, post-intervention at 12 weeks, and at follow-up at 18 weeks, with fall events prospectively monitored on a weekly basis throughout the study period.
Interventions
Twice-weekly for the 12-week duration. The exercise intervention will take place at the nursing homes and consists of 12 weeks of supervised multicomponent exercise training, performed twice weekly on nonconsecutive days to avoid overtraining and fatigue. Each session will last 50-60 min and consist of a warm-up, progressive resistance and power exercises combined with aerobic and balance activities, and a 5-min cool-down period (stretching and flexibility movements). The exercise protocol will follow the Global Consensus on Optimal Exercise recommendations for enhancing healthy longevity in older adults.
OTHERstretching and relaxation program
Twice-weekly for the 12-week duration. The active control Program consist of stretches, deep breathing and relaxation techniques, general (light intensity) physical activity in the sitting position.
Sponsors
Universidade do Porto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
External investigator
Intervention model description
The study will employ a parallel-group randomized clinical trial design, consisting of a 12-week intervention period followed by an 18-week observation period without intervention. Data will be collected at three time points: baseline, at 12 weeks (end of the intervention), and at 18 weeks during the post-intervention follow-up phase.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Ability to ambulate (with or without assistance); * Ability to perform chair stands (with or without assistance); * Ability to understand and properly follow testing procedures.
Exclusion criteria
* Any contraindication that precludes exercise performance or testing procedures, including terminal illness, uncontrolled disease, or other unstable medical conditions; * Short Physical Performance Battery (SPPB) score \< 3 points; * Participation in any exercise intervention within the past 3 months; * Simultaneous participation in another clinical trial during the study; * Planned transfer to another nursing home facility, to home, or to hospitalization during the intervention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline on Short Physical Performance Battery (SPBB) | Baseline, immediately after 12 weeks of intervention and after 18 weeks follow-up | The Short Physical Performance Battery (SPPB) is a standardized assessment tool of lower limb function, testing 3 dimensions: standing balance, walking speed, and chair stands. Each component is scored between 0-4, total score from 0 (poor performance) to 12 (best performance). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline on Timed Up and Go (TUG) | Baseline, immediately after 12 weeks of intervention and after 18 weeks follow-up | The Timed Up and Go (TUG) is a standardized assessment of functional mobility. Briefly, the participants will be instructed to rise from a chair, walk 3 meters at their usual pace, turn around, walk back to the chair, and sit down. The time taken to complete the task will be recorded and used as outcome, with longer durations representing poorer functional mobility. |
| Change from Baseline on Handgrip test | Baseline, immediately after 12 weeks of intervention and after 18 weeks follow-up | Handgrip strength will be obtained with a Digital hand dynamometer (Sammons Preston Inc., Bolingbrook, Illinois, USA). Measurements will be carried out following the American Society of Hand Therapists recommendations, and each participant will perform three attempts with a pause of 15s between trials |
| Falls rate | Weekly tracking over 18-week study period | The number of self-reported falls during the 12-week intervention period (i.e., rate of falls) and follow-up (without intervention). |
| Change from baseline in global cognitive function as measured by the Montreal Cognitive Assessment (MoCA) | Baseline, immediately after 12 weeks of intervention and after 18 weeks follow-up | The Montreal Cognitive Assessment (MoCA) is a brief, standardized cognitive screening tool, that assesses multiple cognitive domains (global cognitive function), including attention, executive functions, memory, language, visuospatial abilities, abstraction, calculation, and orientation. The test consists of a 30-point scale and typically requires approximately 10 minutes to administer. Higher scores indicate better cognitive performance. |
| Change from baseline in executive functions as measured by the Trail Making Test (Part A) and Digit Substitution Symbol Test | Baseline, immediately after 12 weeks of intervention and after 18 weeks follow-up | The Trail Making Test Part A (TMT-A) is a widely used neuropsychological measure of visual attention, processing speed, and psychomotor function. Participants are required to connect numbered circles in sequential order as quickly and accurately as possible. Performance is typically scored by completion time in seconds, with longer times indicating poorer performance. The Digit Symbol Substitution Test (DSST) is a standardized measure of processing speed, attention, working memory, and visuomotor coordination. Participants are asked to match symbols to corresponding numbers according to a reference key within a fixed time (90 seconds). The total number of correct substitutions constitutes the outcome measure, with higher scores reflecting better cognitive performance |
| Change from baseline in mood as measured by the Geriatric Depression Scale | Baseline, immediately after 12 weeks of intervention and after 18 weeks follow-up | The short-version of the Geriatric Depression Scale (GDS-15) is a brief, screening instrument designed to identify depressive symptoms. The total score ranges from 0 to 15, with higher scores indicating greater depressive symptom severity. |
Countries
Portugal
Contacts
CONTACTMaria Joana Carvalho, PhD
PRINCIPAL_INVESTIGATORMaria Joana Carvalho, PhD
Universidade do Porto
Outcome results
None listed