Old Age; DebilityGERYPHYSIONCT06440733
Effectiveness of 8 Week Multicomponent Exercise Program in Older Adults With Frailty and Cognitive Impairment
A study testing Multicomponent exercise program focused in elderly. in people with Old Age; Debility, run by University of Malaga at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Old Age; Debility
- What is being tested?
- Multicomponent exercise program focused in elderly.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSpain
- Study dates
- 30 Sep 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Cristian Carmona Cantalejo
Estación de Cártama, Málaga, 29580
Cristian Carmona Cantalejo, 681180357, criscarcan25@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Old Age; Debility
- Being tested
- Multicomponent exercise program focused in elderly.
- Keywords
- Multicomponent exercise program, Fragility, Elderly, Balance, Quality of life, Autonomy, Functionality
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Multicomponent exercise program focused in elderly. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline up to 8 weeks
Secondary outcomes (5)
Short Form 12 Questionnaire
Check the influence of the multicomponent exercise program on the quality of life of the group of older adults using the Short-Form questionnaire . In this study, a variant of the questionnaire will be used in which Z scores are provided, that is, scores that compare with the average of the population, in this case comparing with the American population, being in both cases an average of 50. Everything that is close to 50 will be considered standard quality of life, everything that is above 50 will be considered good quality of life and everything that is below 50 will be considered bad quality of life.
Measured: Baseline, up to 8 weeks.
Strength in hands.
Analyze changes in the muscle strength of the upper limbs of a group of older adults before and after the multicomponent exercise program using a Jamar hand-held dynamometer. To analyze the muscular strength of the upper limbs of the study subjects, a Jamar dynamometer requested as study material from the University of Malaga will be used, and it will be carried out in a specific pattern. The patient will be placed in a sitting position, with a 90º flexion of the elbow and with the hand making a grip on the handle of the device.
Measured: Baseline, up to 8 weeks.
Barthel Index
Prove the changes in the autonomy of a group of older adults before and after a multicomponent exercise program thanks to the Barthel index for basic activities of daily living. The Barthel index contains 10 items, including bathing, toileting, dressing, feeding, bladder control, toileting, chair or bed transfers, stair climbing, and ambulation. Its items are scored based on the degree of dependence that the patient presents, with a score that can range from 0 to 100, with 0 being a maximum level of dependence and 100 being a maximum level of independence according to the scale.
Measured: Baseline, up to 8 weeks.
Yesavage depression scale
Check the changes at a cognitive, emotional and social level before and after the multicomponent exercise program using Yesavage Geriatric Depression Scale. This scale is scored from 0 to 15, with a score less than 5 being the range of normality, between 5-9 being the range of mild depression, and a score higher than 10 being indicative of moderate to severe depression, being questions with a dichotomous response to items 1, 5, 7, 11, and 13 are considered indicative of depression.
Measured: Baseline, up to 8 weeks.
Lobo Mini Cognitive Examination
Analyze changes at a cognitive, emotional and social level before and after the multicomponent exercise program using Lobo Mini Cognitive Examination. The Lobo Mini Cognitive Examination (MEC) is a test that analyzes the cognitive deterioration of patients, coming from the adaptation of the original test "Mini-Mental State Examination" (MMSE) created by Folstein , performed by Lobo in 1979 .The initial test Mini-Mental State Examination consists of 30 points, unlike the Mini Cognitive Examination, which presents up to a score of 35, analyzing 6 cognitive abilities, plus five more questions on attention, calculation and language, also presenting a completion time of between 10 and 15 minutes. Cognitive impairment is considered to exist when the score is less than 23 points.
Measured: Baseline, up to 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start30 Sep 2023
- Primary completion19 Aug 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Old Age; DebilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rocío Martín Valero, University of Malaga
- Investigators
- Rocío Martín Valero, Study director, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440733
- Sponsor's protocol ID
- UMalagaGER
- Acronym
- GERYPHYSIO
- Status last verified
- May 2024
- First submitted
- 23 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06440733
- Acronym / sponsor ID
- GERYPHYSIO / UMalagaGER
- Conditions
- Old Age; Debility
- Keywords
- Multicomponent exercise program, Fragility, Elderly, Balance, Quality of life, Autonomy, Functionality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 30 Sep 2023 (actual)
- Primary completion
- 19 Aug 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older adults with frailty and cognitive impairment | Experimental | Other: Multicomponent exercise program focused in elderly.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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent exercise program focused in elderly.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. | Other | Older adults with frailty and cognitive impairment |
Primary outcome
Short Physical Performance Battery
Time frame: Baseline up to 8 weeks.
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.
Tinetti scale
Time frame: Baseline up to 8 weeks
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.
5 secondary outcomes
Short Form 12 Questionnaire
Time frame: Baseline, up to 8 weeks.
Strength in hands.
Time frame: Baseline, up to 8 weeks.
Barthel Index
Time frame: Baseline, up to 8 weeks.
Yesavage depression scale
Time frame: Baseline, up to 8 weeks.
Lobo Mini Cognitive Examination
Time frame: Baseline, up to 8 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rocío Martín Valero study director
University of Malaga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent exercise program focused in elderly. in people with Old Age; Debility, run by University of Malaga at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cristian Carmona Cantalejo (681180357, criscarcan25@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Physical Performance Battery (time frame: Baseline up to 8 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.