Effectiveness of 8 Week Multicomponent Exercise Program in Older Adults With Frailty and Cognitive Impairment

NCT06440733 | Recruiting

• 1 other identifier: UMalagaGER
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Old Age; Debility

Keywords

Multicomponent exercise program; Fragility; Elderly; Balance; Quality of life; Autonomy; Functionality

Outcome Measures

Primary Outcomes (2)

• Short Physical Performance Battery

  Analyze if there are changes in general physical condition and frailty after an 8 week multicomponent exercise program in a group of older adults before and after carrying it out using the Short Physical Performance Battery questionnaire. The score obtained with this geriatric evaluation test ranges between 0 and 12 points, and can be interpreted depending on the result obtained as: severe limitation or disabled between 0-3, moderate limitation or fragile/vulnerable between 4-6, limitation mild or pre-frail between 7-9, minimal limitation or autonomous/healthy between 10-12. However, if the participant obtains a score of less than 10 on the SPPB, it can be used as a mortality assessment criterion in studies that need to quantify the health benefits and improvements of specific treatments or rehabilitation programs, such as case of this present study.

  Baseline up to 8 weeks.

• Tinetti scale

  Analyze the risks of falling before performing the multicomponent exercise program and after it, seeing if there is variation in it in the group of older adults using the Tinetti scale for balance and gait. The maximum score achievable with this scale is 28 points and 16 of them coming from the balance sphere, and 12 points coming from the gait sphere. So: High risk of falling: score less than 19 points, Average risk of falling: 19 to 23 points, and Low risk of falling: 24 to 28 points.

  Baseline up to 8 weeks

Secondary Outcomes (5)

• Short Form 12 Questionnaire

  Baseline, up to 8 weeks.

• Strength in hands.

  Baseline, up to 8 weeks.

• Barthel Index

  Baseline, up to 8 weeks.

• Yesavage depression scale

  Baseline, up to 8 weeks.

• Lobo Mini Cognitive Examination

  Baseline, up to 8 weeks.

Study Arms (1)

Older adults with frailty and cognitive impairment

EXPERIMENTAL

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.

Other: Multicomponent exercise program focused in elderly.

Interventions

Multicomponent exercise program focused in elderly. OTHER

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. All sessions will begin with a 5-minutes. 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.

Older adults with frailty and cognitive impairment

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaga: lead

Study Sites (1)

Cristian Carmona Cantalejo

Estación de Cártama, Málaga, 29580, Spain

RECRUITING

MeSH Terms

Conditions

Frailty

Interventions

Aging

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Growth and Development; Physiological Phenomena

Study Officials

• Rocío Martín Valero

  University of Malaga

  STUDY DIRECTOR

Central Study Contacts

Cristian Carmona Cantalejo

CONTACT

681180357; criscarcan25@gmail.com

Rocío Martín Valero, PhD

CONTACT

951952858; rovalemas@uma.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 4, 2024
• Study Start: September 30, 2023
• Primary Completion: August 19, 2024
• Study Completion: September 30, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)