Health-related Quality of Life in Elderly Adults Following Physical Exercise and Cognitive Training: a Randomized-controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 156
- Locations
- 1
- Primary Endpoint
- Quality of Life assessed by the short-form 36 (SF-36) questionnaire
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 70 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male and female
- •Age ≥ 70 years
- •Provision of the informed consent form
Exclusion Criteria
- •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
Arms & Interventions
Structured Exercise Program + Cognitive training
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.
Intervention: EXERCISE TRAINING WITH OR WITHOUT MEDICATION (Behavioral)
Structured Exercise Program + Cognitive stimulus
In addition to the exercise program, 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.
Intervention: EXERCISE TRAINING WITH OR WITHOUT MEDICATION (Behavioral)
Structured Exercise Program
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.
The exercise program will be the same for all the three groups
Intervention: EXERCISE TRAINING WITH OR WITHOUT MEDICATION (Behavioral)
Outcomes
Primary Outcomes
Quality of Life assessed by the short-form 36 (SF-36) questionnaire
Time Frame: Baseline; end of the program (3-month); Follow-up (6-month)
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).
Quality of Life assessed by the short-form 36 (SF-36) questionnaire
Time Frame: Baseline; end of the program (3-month); Follow-up (6-month)
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).
Secondary Outcomes
- Cognitive capacity assessed by the Montreal Cognitive Assessment (MoCA)(Baseline; end of the program (3-month); Follow-up (6-month))
- Walking endurance assessed by the 6-Minute Walking Test (6MWT)(Baseline; end of the program (3-month); Follow-up (6-month))
- Short Physical Performance Battery (SPPB)(Baseline; end of the program (3-month); Follow-up (6-month))
- Manual grip strength using the Handgrip Test (HT)(Baseline; end of the program (3-month); Follow-up (6-month))
- Sleep quality through the Pittsburgh Sleep Quality Index (PSQI)(Baseline; end of the program (3-month); Follow-up (6-month))
- Quality of life assessed by the Quality of Life in Alzheimer's Disease (QOL-AD) questionnaire(Baseline; end of the program (3-month); Follow-up (6-month))
- Executive function and processing speed assessed by the Trail Making Test (TMT)(Baseline; end of the program (3-month); Follow-up (6-month))
- Timed Up-and-Go test(Baseline; end of the program (3-month); Follow-up (6-month))
Investigators
Fabio Manfredini
Full Professor
University Hospital of Ferrara