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

Official title

Health-related Quality of Life in Elderly Adults Following Physical Exercise and Cognitive Training: a Randomized-controlled Trial

Overview

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

Interventions

• Behavioral EXERCISE TRAINING WITH OR WITHOUT MEDICATION
  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.
• Behavioral EXERCISE TRAINING WITH OR WITHOUT MEDICATION
  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.
• Behavioral EXERCISE TRAINING WITH OR WITHOUT MEDICATION
  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.

Primary outcome measures

• 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)]

Secondary outcome measures (8)

• Quality of life assessed by the Quality of Life in Alzheimer's Disease (QOL-AD) questionnaire [Time frame: Baseline; end of the program (3-month); Follow-up (6-month)]
• Cognitive capacity assessed by the Montreal Cognitive Assessment (MoCA) [Time frame: Baseline; end of the program (3-month); Follow-up (6-month)]
• Executive function and processing speed assessed by the Trail Making Test (TMT) [Time frame: Baseline; end of the program (3-month); Follow-up (6-month)]
• Walking endurance assessed by the 6-Minute Walking Test (6MWT) [Time frame: Baseline; end of the program (3-month); Follow-up (6-month)]
• Short Physical Performance Battery (SPPB) [Time frame: Baseline; end of the program (3-month); Follow-up (6-month)]
• Manual grip strength using the Handgrip Test (HT) [Time frame: Baseline; end of the program (3-month); Follow-up (6-month)]
• Sleep quality through the Pittsburgh Sleep Quality Index (PSQI) [Time frame: Baseline; end of the program (3-month); Follow-up (6-month)]
• Timed Up-and-Go test [Time frame: Baseline; end of the program (3-month); Follow-up (6-month)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Italy · 1 center

• Esercizio Vita — Ferrara

Identifiers

NCT: NCT07244536 · 416/2025/Sper/UniFe

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗