CClinicalTrials.gg
CompletedNCT06426589Updated May 29, 2024

Exercise and Nutrition in the Mental Health of the Older Adult Population

An interventional study of Resistence training and mediterranean diet in Older Adults, sponsored by University of Jaén. Completed at 1 site in Spain. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-05-29.

Sponsored by University of Jaén · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Oct 2023, registered May 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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 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

02

Conditions studied

  • Older Adults
03

In context

Lead sponsor

University of Jaén is the lead sponsor of 79 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
108 participants (actual)

Study arms

  • No intervention
    Control Group

    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
    Experimental Group

    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.

    Other: Resistence training and mediterranean diet

Interventions

  • OtherResistence training and mediterranean diet

    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%.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to twelve weeks

  2. 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

    Time frame: Up to twelve weeks

  3. 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.

    Time frame: Up to twelve weeks

  4. 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.

    Time frame: Up to twelve weeks

07

Study locations

1 site
  • Agustín Aibar Almazán
    Jaén, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06426589
Lead sponsor
University of Jaén
Responsible party
Agustín Aibar Almazán (Principal investigator, University of Jaén) — Principal investigator
First posted
May 23, 2024
Start date
Oct 23, 2023
Primary completion
Jan 19, 2024
Completion
Jan 26, 2024
Last update
May 29, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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