Effects of Physical Exercise and Cognitive Training on Quality of Life in Elderly Adults

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorUniversity Hospital of Ferrara

About this trial

The aim of the study is to investigate the effectiveness of three different types of intervention, based on physical exercise and/or cognitive stimulation or training, on quality of life, cognition and mobility, on a population of older adults, who are most at risk of functional and cognitive decline

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male and female

Age ≥ 70 years

Provision of the informed consent form

Disqualifiers

Absolute contraindications to physical exercise (e.g. NYHA class IV heart failure, unstable angina, etc.)

Pregnancy

Severe cognitive impairment, defined as a MoCa score ≤ 12

Severe visual impairment or blindness

Trial design

Design model

Parallel

Treatments tested in this trial

  • EXERCISE TRAINING WITH OR WITHOUT MEDICATION

    Behavioral

    The program includes 75-minute training sessions twice a week, for a total of 24 training sessions over 12 weeks. Each training session will be divided into a warm-up, training phase and cool-down, and will include aerobic exercises, resistance training, balance exercises, mobility exercises and stretching.

  • EXERCISE TRAINING WITH OR WITHOUT MEDICATION

    Behavioral

    In addition to the exercise program, Participants will be given a series of cognitive exercises aimed at improving prospective memory through the performance of certain oral tasks, administered by a member of the research team. All cognitive exercises will be adapted to the cognitive abilities of the participants.

  • EXERCISE TRAINING WITH OR WITHOUT MEDICATION

    Behavioral

    In addition to the exercise training, people will receive a short video lasting less than 10 minutes on their smartphone or tablet before the exercise session (or at home). At the end of the video, they will be asked to complete a 10-question questionnaire (also delivered via smartphone or tablet) with True or False answer options.

Treatment groups

156 Participants
are divided into 3 treatment groups
Group A: Structured Exercise Program + Cognitive trainingExperimental treatment 1 intervention
Group B: Structured Exercise Program + Cognitive stimulusExperimental treatment 1 intervention
Group C: Structured Exercise ProgramActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Quality of Life assessed by the short-form 36 (SF-36) questionnaire

This is a generic questionnaire that contains 36 questions referring to 8 specific domains related to patient health over the previous 4 weeks. For each specific domain, the score ranges from 0 (lowest quality of life) to 100 (highest quality of life).

Time frame
Baseline; end of the program (3-month); Follow-up (6-month)

Secondary outcomes

1

Quality of life assessed by the Quality of Life in Alzheimer's Disease (QOL-AD) questionnaire

QOL-AD consists of 13 questions covering various aspects of daily life, such as physical health, energy, mood, relationships and the ability to enjoy enjoyable activities. The combined scores of the patient and caregiver provide a more comprehensive and accurate picture of the person's overall well-being. The scale has a score ranging from 13 (lowest quality of life) to 52 (highest quality of life).

Time frame
Baseline; end of the program (3-month); Follow-up (6-month)
2

Cognitive capacity assessed by the Montreal Cognitive Assessment (MoCA)

MoCA is a 30-point test evaluates cognitive function. Its primary purpose is to detect mild cognitive impairment (MCI). The score goes from 0 (maximal cognitive deficit) to 30 (normal cognitive function).

Time frame
Baseline; end of the program (3-month); Follow-up (6-month)
3

Executive function and processing speed assessed by the Trail Making Test (TMT)

TMT is neuropsychological test that assesses a person's cognitive function, specifically focusing on visual attention, processing speed, and executive function. The test consists of two parts, the score is based on the time it takes to complete each part, with shorter times indicating better performance.

Time frame
Baseline; end of the program (3-month); Follow-up (6-month)
4

Walking endurance assessed by the 6-Minute Walking Test (6MWT)

The patients will be instructed to walk back and forth on a 20-meter corridor aiming at covering as much distance as possible. The total distance covered (6MWD) will be measured in meters

Time frame
Baseline; end of the program (3-month); Follow-up (6-month)

Other outcomes

Sponsors and contacts

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University Hospital of Ferrara

Lead sponsor

Università degli Studi di Ferrara

Collaborator