Older AdultsNCT06426589
Exercise and Nutrition in the Mental Health of the Older Adult Population
A study testing Resistence training and mediterranean diet in people with Older Adults, run by University of Jaén at 1 site in Spain.
Trial summary
Resistance exercise and the Mediterranean diet are complementary, evidence-based approaches to improving physical and mental health throughout all stages of life. For older adults, maintain flexibility, muscle strength, balance and posture, reducing the risk of falls and injuries; They relieve chronic pain, improve… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Older Adults
- What is being tested?
- Resistence training and mediterranean diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSpain
- Study dates
- 23 Oct 2023to 26 Jan 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
- Were 65 years or older were eligible for the study
- Had not been part of any resistance program in the last 12 months
- They could understand and follow the instructions, activities and protocols of the exercise program.
Who cannot join
- They suffered from any systemic condition (e.g., neurodegenerative, musculoskeletal, or visual diseases) that prevented them from performing the exercises.
- Had any vestibular disease or disorder
- Consumed medications that influenced the central nervous system, balance or coordination (for example, antidepressants, vestibular sedatives or anxiolytics).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Resistance Training and Mediterranean Diet in the Mental Health of the Older Adult Population: a Randomized Controlled Clinical Trial
Resistance exercise and the Mediterranean diet are complementary, evidence-based approaches to improving physical and mental health throughout all stages of life.
For older adults, maintain flexibility, muscle strength, balance and posture, reducing the risk of falls and injuries; They relieve chronic pain, improve sleep quality, and reduce stress and anxiety. For young people, they improve concentration, attention and memory, reduce stress and anxiety, promote a positive body image and increase self-esteem. Overall benefits include promoting the mind-body connection, facilitating healthy aging, and being accessible and adaptable to various individual and socioeconomic needs.
Read more
The main components of the Mediterranean diet are: high in fruits, vegetables, legumes, nuts, whole grains, fish and olive oil; moderate in dairy and red wine; and low in red meat and processed products. Benefits for older adults include reducing the risk of cardiovascular disease, decreasing chronic diseases and pro-inflammatory factors, and preventing obesity and cognitive decline. The overall impact improves bone and cardiovascular health, and strengthens the immune system.
The combination of resistance exercise and a Mediterranean diet offers a comprehensive approach to improving health and well-being throughout life, promoting physical and mental health, facilitating active and healthy aging, and being accessible and beneficial for people of all socioeconomic backgrounds
- Conditions
- Older Adults
- Being tested
- Resistence training and mediterranean diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistence training and mediterranean dietOther
Resistance training. Subjects assigned to the experimental group participated in resistance program twice a week (on Tuesdays and Thursdays) for a period of 12 weeks, totaling 24 sessions of 60 minutes each. Each session during this time was divided into three clearly differentiated parts: i) 5-minute warm-up comprised of a series of gentle, low-intensity exercises designed to gradually prepare the muscles and joints of older adults for the main exercise.
Mediterranean Diet. In addition to the resistance intervention, the experimental group received a Mediterranean diet protocol based on the study by Ismail et al. [34] with the following meal plan: i) carbohydrates constituted 50% of daily intake; ii) fats repre-sented 35%; and iii) proteins accounted for 15%.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The control group (CG) will not undergo treatment, which will be evaluated in the pre- and post-phase of the study. Participants assigned to this group will receive general advice on the positive effects of regular physical activity, and they will be given the guide of recommendations for the promotion of physical activity. |
| Experimental Group | Experimental | The experimental group (EG), after an initial evaluation, will be subjected to a physical training program based on the resistance training, for 12 weeks with 2 weekly sessions (Tuesday and Thursday), with a duration of 45 minutes per session. Once the intervention is finished, you will undergo a final evaluation again to see if there is a difference or not with the results obtained at the beginning. In addition to the resistance training intervention, the experimental group received a Mediterranean diet protocol. Receives: Other: Resistence training and mediterranean diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the Mediterranean Diet
This was measured using the 14-item Mediterranean Diet Adherence Questionnaire (MEDAS) questionnaire, developed by the Prevention with Mediterranean Diet (PREDIMED) researchers. The questionnaire consists of 12 queries regarding how often various foods are eaten and two additional questions concerning typical eating habits in Spain [35]. Each question could be answered with a score of either zero or one. The total possible score ranged from 0 to 14, with a total of 9 or higher signifying sufficient compliance with the Mediterranean diet.
Measured: Up to twelve weeks
Anxiety and depression
To evaluate anxiety and depression levels, the Hospital Anxiety and Depression Scale (HADS) was used [36,37]. This instrument is frequently used in populations of older adults who are not institutionalized [38] and includes 14 questions, divided equally between anxiety (even questions) and depression (even questions). Items are scored on a scale of 0 to 3, resulting in a total score range of 0 to 21 for both anxiety and depression, with a higher number indicating a greater presence of symptoms.
Sleep quality
Measured: Up to twelve weeks
Sleep quality
The Pittsburgh Sleep Quality Index (PSQI) [39,40], a widely recognized tool for the assessment of sleep quality, was the questionnaire selected for this task. The PSQI includes 19 self-report items and 5 additional items that must be completed by the participant's bed partner or roommate (the latter are used only to obtain clinical data). From these items, a global score is calculated and seven dimensions or areas are evaluated: sleep quality; time to fall asleep; sleep duration; sleep efficiency; problems during sleep; consumption of sleep medication; and daytime functioning problems. The total score on the PSQI ranges from 0 to 21, with higher scores indicating poor sleep quality.
Measured: Up to twelve weeks
Perceived stress
The measurement of perceived stress was carried out using the Perceived Stress Scale (PSS) [41] in its version for the Spanish language [42], an instrument composed of 14 questions that determines the degree of stress felt in the last month. This questionnaire uses a response system based on a five-point scale (0 = never, 1 = almost never, 2 = occasionally, 3 = frequently, 4 = very frequently). To calculate the total score on the PSS, the response values for items 4, 5, 6, 7, 9, 10, and 13 are reversed (so that 0 becomes 4, 1 becomes 3, etc.) and Then all the items are added. The score ranges from 0-56, with a higher score on the scale indicating a higher level of perceived stress.
Measured: Up to twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start23 Oct 2023
- Primary completion19 Jan 2024
- Study completion26 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older AdultsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agustín Aibar Almazán, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426589
- Sponsor's protocol ID
- UJA.2024
- Status last verified
- May 2024
- First submitted
- 17 May 2024
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- 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 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance Training and Mediterranean Diet in the Mental Health of the Older Adult Population: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06426589
- Acronym / sponsor ID
- UJA.2024
- Conditions
- Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 19 Jan 2024 (actual)
- Study completion
- 26 Jan 2024 (actual)
- First posted
- 23 May 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.
Resistance exercise and the Mediterranean diet are complementary, evidence-based approaches to improving physical and mental health throughout all stages of life.
For older adults, maintain flexibility, muscle strength, balance and posture, reducing the risk of falls and injuries; They relieve chronic pain, improve sleep quality, and reduce stress and anxiety. For young people, they improve concentration, attention and memory, reduce stress and anxiety, promote a positive body image and increase self-esteem. Overall benefits include promoting the mind-body connection, facilitating healthy aging, and being accessible and adaptable to various individual and socioeconomic needs.
The main components of the Mediterranean diet are: high in fruits, vegetables, legumes, nuts, whole grains, fish and olive oil; moderate in dairy and red wine; and low in red meat and processed products. Benefits for older adults include reducing the risk of cardiovascular disease, decreasing chronic diseases and pro-inflammatory factors, and preventing obesity and cognitive decline. The overall impact improves bone and cardiovascular health, and strengthens the immune system.
The combination of resistance exercise and a Mediterranean diet offers a comprehensive approach to improving health and well-being throughout life, promoting physical and mental health, facilitating active and healthy aging, and being accessible and beneficial for people of all socioeconomic backgrounds
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The control group (CG) will not undergo treatment, which will be evaluated in the pre- and post-phase of the study. Participants assigned to this group will receive general advice on the positive effects of regular physical activity, and they will be given the guide of recommendations for the promotion of physical activity. |
| Experimental Group | Experimental | Other: Resistence training and mediterranean dietThe experimental group (EG), after an initial evaluation, will be subjected to a physical training program based on the resistance training, for 12 weeks with 2 weekly sessions (Tuesday and Thursday), with a duration of 45 minutes per session. Once the intervention is finished, you will undergo a final evaluation again to see if there is a difference or not with the results obtained at the beginning. In addition to the resistance training intervention, the experimental group received a Mediterranean diet protocol. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Were 65 years or older were eligible for the study
- Had not been part of any resistance program in the last 12 months
- They could understand and follow the instructions, activities and protocols of the exercise program.
Key exclusion criteria (3 listed)
- They suffered from any systemic condition (e.g., neurodegenerative, musculoskeletal, or visual diseases) that prevented them from performing the exercises.
- Had any vestibular disease or disorder
- Consumed medications that influenced the central nervous system, balance or coordination (for example, antidepressants, vestibular sedatives or anxiolytics).
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 |
|---|---|---|
| Resistence training and mediterranean dietResistance training. Subjects assigned to the experimental group participated in resistance program twice a week (on Tuesdays and Thursdays) for a period of 12 weeks, totaling 24 sessions of 60 minutes each. Each session during this time was divided into three clearly differentiated parts: i) 5-minute warm-up comprised of a series of gentle, low-intensity exercises designed to gradually prepare the muscles and joints of older adults for the main exercise. Mediterranean Diet. In addition to the resistance intervention, the experimental group received a Mediterranean diet protocol based on the study by Ismail et al. [34] with the following meal plan: i) carbohydrates constituted 50% of daily intake; ii) fats repre-sented 35%; and iii) proteins accounted for 15%. | Other | Experimental Group |
Primary outcome
Adherence to the Mediterranean Diet
Time frame: Up to twelve weeks
This was measured using the 14-item Mediterranean Diet Adherence Questionnaire (MEDAS) questionnaire, developed by the Prevention with Mediterranean Diet (PREDIMED) researchers. The questionnaire consists of 12 queries regarding how often various foods are eaten and two additional questions concerning typical eating habits in Spain [35]. Each question could be answered with a score of either zero or one. The total possible score ranged from 0 to 14, with a total of 9 or higher signifying sufficient compliance with the Mediterranean diet.
Anxiety and depression
Time frame: Up to twelve weeks
To evaluate anxiety and depression levels, the Hospital Anxiety and Depression Scale (HADS) was used [36,37]. This instrument is frequently used in populations of older adults who are not institutionalized [38] and includes 14 questions, divided equally between anxiety (even questions) and depression (even questions). Items are scored on a scale of 0 to 3, resulting in a total score range of 0 to 21 for both anxiety and depression, with a higher number indicating a greater presence of symptoms. Sleep quality
Sleep quality
Time frame: Up to twelve weeks
The Pittsburgh Sleep Quality Index (PSQI) [39,40], a widely recognized tool for the assessment of sleep quality, was the questionnaire selected for this task. The PSQI includes 19 self-report items and 5 additional items that must be completed by the participant's bed partner or roommate (the latter are used only to obtain clinical data). From these items, a global score is calculated and seven dimensions or areas are evaluated: sleep quality; time to fall asleep; sleep duration; sleep efficiency; problems during sleep; consumption of sleep medication; and daytime functioning problems. The total score on the PSQI ranges from 0 to 21, with higher scores indicating poor sleep quality.
Perceived stress
Time frame: Up to twelve weeks
The measurement of perceived stress was carried out using the Perceived Stress Scale (PSS) [41] in its version for the Spanish language [42], an instrument composed of 14 questions that determines the degree of stress felt in the last month. This questionnaire uses a response system based on a five-point scale (0 = never, 1 = almost never, 2 = occasionally, 3 = frequently, 4 = very frequently). To calculate the total score on the PSS, the response values for items 4, 5, 6, 7, 9, 10, and 13 are reversed (so that 0 becomes 4, 1 becomes 3, etc.) and Then all the items are added. The score ranges from 0-56, with a higher score on the scale indicating a higher level of perceived stress.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistence training and mediterranean diet in people with Older Adults, run by University of Jaén 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 29 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the Mediterranean Diet (time frame: Up to twelve weeks). The study lists 4 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 29 May 2024.