Effects of Physical Exercise and Cognitive Training on Quality of Life in Older Women
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age60+
SponsorUniversity Hospital of Ferrara
About this trial
Ageing exposes people to a progressive loss of cognitive and functional abilities, especially in women. The aim of the study is to investigate the effectiveness of 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 women.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female
Age ≥ 60 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
BehavioralThe exercise 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 plus cognitive training
BehavioralIn 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 plus cognitive stimulus at home
BehavioralIn addition to the exercise program, participants 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
124 Participants
are divided into 4 treatment groupsGroup A: Experimental 1 - Exercise plus cognitive trainingExperimental treatment 1 intervention
Group B: Experimental 2 - Exercise plus cognitive stimulusExperimental treatment 1 intervention
Group C: Active comparator - Exercise onlyActive comparator 1 intervention
Group D: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Executive function and processing speed 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)Secondary outcomes
1
Quality of life 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). This measure will be collected in people with MCI only
Time frame
Baseline; end of the program (3-month); Follow-up (6-month)2
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)3
Cognition 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)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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital of Ferrara
Lead sponsor
Università degli Studi di Ferrara
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: