Biogipuzkoa Health Research Institute. Primary Care Group. Epidemiology, Public Health and Primary Care Area.
San Sebastián, Gipuzkoa, 20014, Spain
NCT Number: NCT07637890
This pilot study tested whether a new program for older adults with frailty could realistically be carried out in primary health care. That is why the main objective of this study was to evaluate the viability and feasibility of the newly designed frailty intervention.
People over 65 were recruited in two health centers and invited to join a 3 month program combining group exercise, a medication review by a pharmacist, and nutrition workshops. The study also collected information on mobility, strength, nutrition, mood, cognition, and quality of life. Most measures were taken at the start and again four and eight months later.
The results will help refine the program and guide the design of a larger clinical trial.
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Notify Me65 year and older
All sexes
Interventional
Not applicable
San Sebastián, Gipuzkoa, 20014, Spain
The study assessed the viability and feasibility of a frailty intervention in routine clinical practice through a prospective one-arm pilot conducted in two primary care centers in Donostia (Gipuzkoa, Basque Country, Spain). Participants were adults aged 65 or older, functionally independent (Barthel >90) and classified as frail (Short Physical Performance Battery <10), who received a 12-week physical exercise program, nutritional counseling, and a pharmacological review.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Physical exercise: one-hour group sessions, twice a week for 12 consecutive weeks, at the Municipal Sports centre led by a licensed sports instructor. All sessions followed a standardized structure consisting of a warm-up phase of approximately 25 minutes, a strengthening phase of about 25 minutes adjusted to each participant's physical condition, and a final 10-minute relaxation phase including flexibility and balance exercises. Polypharmacy review: a primary care pharmacist reviewed the pharmacological treatments of each participant in order to detect potentially inappropriate prescriptions, following the STOPP/START criteria. Nutritional care: the dietary intervention consisted of three group workshops, one per month, lasting for an hour each. The three workshops, led by a nutritionist, covered the basics of healthy eating, dietary adaptations for specific conditions with recipe ideas, and strategies to prevent malnutrition and sarcopenia.
Time frame: Baseline
The numbers of pre-selected participants who met the inclusion criteria and eventually agreed to participate, as well as the drop-outs and their reasons were registered.
Time frame: Baseline
The time required to recruit the sample needed for the study was recorded.
Time frame: From baseline to 8 months
The professionals recorded the evaluation time each participant required
Time frame: From baseline to 8 months
Professionals who performed the baseline and follow-up assessments completed a questionnaire on the difficulty and adequacy of the process
Time frame: From baseline to 4 months
Number of attended sessions was registered
Time frame: Month 4
Satisfaction was measured with an anonymous ad-hoc questionnaire, containing a total of 25 questions: The physical exercise and the nutritional components were evaluated with six questions each; general health improvements obtained during the intervention with 11; two last questions asked about the intention to keep exercising after the intervention ended and whether they would recommend this program to others.
Time frame: From baseline to 8 months
The Timed Up and Go (TUG) test was used to assess functional capacity. TUG is a simple functional assessment used to evaluate mobility, balance, and fall risk. Participants are timed while standing up from a chair, walking three meters, turning, returning, and sitting down. Shorter times (in seconds) indicate better functional mobility, while longer times suggest impaired performance.
Time frame: From baseline to 8 months
Physical activity was assessed using the International Physical Activity Questionnaire (IPAQ). It is a standardized instrument used to assess physical activity performed during the previous seven days, including walking, moderate activity, vigorous activity, and sedentary behavior. The questionnaire applies Metabolic Equivalent of Task (MET) values to estimate weekly energy expenditure and classify participants into low, moderate, or high physical activity levels. The unit of measurement is MET.
Time frame: From baseline to 8 months
Handgrip strength measured with a dynamometer. Three dominant hand consecutive measurement were taken per participant. The finally considered values per follow-up were the means of those three. The unit of measurement is kg.
Time frame: From baseline to 8 months
The Predimed questionnaire is a validated 14-item tool used to assess adherence to the Mediterranean diet, by asking about key dietary habits. Its score oscillates between 0-14 points, with higher values indicating greater adherence.
Time frame: From Baseline to 8 months
The 6-item Mini Nutritional Assessment-Short Form (MNA-SF) was applied to evaluate the nutritional status of patients. The Mini Nutritional Assessment (MNA) is an 18-item validated tool used to evaluate nutritional status in older adults. The unit of measurement is points.
Time frame: Frome baseline to 4 months
Complete blood count, biochemistry (glucose, urea, creatinine, thyroid hormones, vitamins B12 and D, ions, iron profile), albumin, and C-reactive protein were collected.
Time frame: From Baseline to 4 months
Change in the number of pharmacological treatments.
Time frame: From baseline to 8 months
The Euroqol Visual Analog Scale (EQ-VAS) was used for assessing self-reported quality of life. It is a vertical 0-100 line measuring overall health "today", with 100 being the best possible health.
Time frame: From baseline to 8 months
The Abbreviated Mini-Mental State Examination (MMSE-Short Form) was performed to assess the global cognitive function of the participants. It evaluates orientation, memory, attention, and language in 21 items, and provides a rapid estimate of cognitive status, with lower scores indicating greater impairment.
Time frame: From baseline to 8 months
Anxiety and depression was determined by the Goldberg Anxiety and Depression Scale. A brief screening instrument used to identify symptoms of anxiety and depression in adults. It consists of two subscales with nine items each, and the total scores help detect individuals at risk of clinically relevant emotional distress. Lower values indicate less anxiety and depression.
Time frame: From Baseline to 8 months
Lawton instrumental activities of daily living based on 8 items, with higher values indicating more independence.
Time frame: From baseline to 8 months
The Lubben Social Networks Scale is a brief, standardised tool used to assess social connectedness in older people. It measures the number and frequency of contacts within family and friends and the perception on the availability of support. The family and friends sub-scales account for a maximum of 15 points each, with the total scale score ranging from 0 to 30 points. Higher values indicate more social ties.
Biogipuzkoa Health Research Institute
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