Frailty
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERMulti-component intervention: physical exercise, polypharmacy review and nutritional care
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.
Sponsors
Biogipuzkoa Health Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \>65 years old * Barthel \>90 points (independent) * Short Physical Performance Battery \<10 points (frail)
Exclusion criteria
* Having a terminal condition * Suffering from pathologies with a poor prognosis * Having difficulty in performing physical activities * Not being able to communicate fluently in Spanish * Presenting intellectual disabilities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rates | 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 required to recruit the sample | Baseline | The time required to recruit the sample needed for the study was recorded. |
| Participants evaluation time | From baseline to 8 months | The professionals recorded the evaluation time each participant required |
| Professionals' opinion on the difficulty and adequacy of the process | 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 |
| Adherence to the intervention | From baseline to 4 months | Number of attended sessions was registered |
| Participant satisfaction | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Functional Capacity at 4 and 8 months | 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. |
| Change from Baseline in Physical Activity at 4 and 8 months | 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. |
| Change from Baseline in Handgrip Strength at 4 and 8 months | 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. |
| Change from Baseline in Eating Habits at 4 and 8 months | 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. |
| Change from Baseline in Nutritional Status at 4 and 8 months | 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. |
| Change from Baseline in Blood tests at 4 months | 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. |
| Change from Baseline in Pharmacological treatments at 4 months | From Baseline to 4 months | Change in the number of pharmacological treatments. |
| Change from Baseline in the Health-related quality of life at 4 and 8 months | 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. |
| Change from Baseline in Cognitive Status at 4 and 8 months | 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. |
| Change from Baseline in Anxiety and Depression Status at 4 and 8 months | 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. |
| Change from Baseline in Dependence at 4 and 8 months | From Baseline to 8 months | Lawton instrumental activities of daily living based on 8 items, with higher values indicating more independence. |
| Change from Baseline in Social Connectedness at 4 and 8 months | 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. |
Countries
Spain
Outcome results
None listed