Clinical trial NCT06440733: Effectiveness of 8 Week Multicomponent Exercise Program in Older Adults With Frailty and Cognitive Impairment
Official title: Effectiveness of 8 Week Multicomponent Exercise Program on the General Health and Balance of a Group of Older Adults With Frailty and Cognitive Impairment: a Quasi-experimental Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Old Age; Debility
Keywords: Multicomponent exercise program
Fragility
Elderly
Balance
Quality of life
Autonomy
Functionality
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 17
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Multicomponent exercise program in a frail population. It is analyzed whether there is an improvement in different parameters of the daily life of the study subjects, analyzing the variables of: physical condition, fragility, balance, quality of life, upper limb strength, autonomy, cognitive state and depression.

Detailed description: In this study, an 8-week multicomponent exercise program will be carried out focused on improving the general physical condition and balance of older adult subjects, in order to try to reduce the risk of falls and improve the quality of life of a group. of older adults made up of 17 participants.

During these 8 weeks, this intervention program will be carried out at least 3 times a week, for 50-55 minutes, which will consist of 4 typical sessions, based mainly on 5 large groups: weights, magic rings, elastic bands, ballasts and pikes... Each of these sessions will be carried out taking into account the main physiotherapy objectives, such as gaining strength in both upper and lower limbs, as well as proprioception, balance, and promoting a pleasant and safe social environment where these older people feel valid, capable of carrying out the program and everything is provided to them in a friendly and fun way, and always taking into account as far as possible , the individual characteristics of each study participant. All sessions will begin with a 5-minute aerobic exercise and end with a stretching program for another 5 minutes, to ensure you return to calm, along with breathing exercises.

The intervention will begin by carrying out an initial evaluation already developed previously, and after this, standard sessions will begin, in which they will all begin and end in the same way. It will begin with a general warm-up based on general joint mobility of the head and neck, shoulders, trunk, elbows, hands, wrists, hips, knees and ankles to begin to accustom the body to the physical work environment. And at the end of the sessions, a stretching program will be carried out, and it will end with a return to calm with a respiratory training program, in which you will be instructed to take in air through the nose and release it through the mouth, while the room is silent, and thus promote self-awareness.

Eligibility criteria: Inclusion Criteria:

* Adults over 65 years of age.
* People with frailty according to the Short Physical Performance Battery,
* who have the ability to walk (autonomous or with external aids),
* and who obtain a score greater than or equal to 15 in the Lobo Mini Cognitive Examination (MEC-35 of Lobo).
* patients with a resolved hip fracture, with Parkinson's,
* Patients who are committed and motivated to carry out the study, as well as patients who agree to sign the informed consent and the report sheet prior to carrying out the study.

Exclusion Criteria:

* Old Adults under 65 years of age.
* Patients who do not present frailty or the ability to walk (autonomous or with external aids).
* People who obtain a score of less than 15 in the Lobo Mini Cognitive Exam therefore presenting a serious deterioration of the emotional and cognitive state.
* Older adults who are under treatment with tranquilizers or sedatives, non-diuretic hypotensive agents or antidepressants.
* Patients with amyotrophic lateral sclerosis, multiple sclerosis, diabetic neuropathy, severe sensory deficit, and study subjects without motivation or interest in participating in the study.
* Older adults who do not agree to sign the study, will also be excluded from the study. informed consent and the report sheet prior to carrying out the study

Primary outcomes:
measure: Short Physical Performance Battery
timeFrame: Baseline up to 8 weeks.
measure: Tinetti scale
timeFrame: Baseline up to 8 weeks
Secondary outcomes:
measure: Short Form 12 Questionnaire
timeFrame: Baseline, up to 8 weeks.
measure: Strength in hands.
timeFrame: Baseline, up to 8 weeks.
measure: Barthel Index
timeFrame: Baseline, up to 8 weeks.
measure: Yesavage depression scale
timeFrame: Baseline, up to 8 weeks.
measure: Lobo Mini Cognitive Examination
timeFrame: Baseline, up to 8 weeks.
Other outcomes:
Locations:
city: Estación de Cártama
country: Spain
facility: Cristian Carmona Cantalejo
state: Málaga
Study officials:
affiliation: University of Malaga
name: Rocío Martín Valero
role: STUDY_DIRECTOR
References: