← Back to all trials
Recruiting
NCT05619250
Supervised Center-based vs. Unsupervised Home-based Exercise Programs (PRO-Training)
Conditions: Physical Inactivity, Healthy, Older Adult
Sex: All
Ages: 60 Years – 75 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 120
Sponsor: University of Castilla-La Mancha
Location: Spain
Summary
The superiority of supervised center-based training programs compared with unsupervised home-based ones in older adults remains unclear, and no evidence exists on whether including a motivational component could moderate these differences.
The present randomized controlled trial aims to determine the role of supervision and motivational strategies on the safety, adherence, efficacy, and cost-effectiveness of different training programs for improving physical and mental health in older adults.
Participants (n=120, aged 60-75 years old) will be randomly divided into five groups: 1- Control group, 2- Unsupervised home-based exercise group without motivational intervention (UNSUP), 3- Unsupervised home-based exercise group with motivational intervention (UNSUP+), 4- Supervised center-based exercise group without motivational intervention (SUP) and 5- Supervised center-based exercise group with motivational intervention (SUP+).
Participants assigned to the exercise groups will participate in a 24-week multicomponent exercise program (3 sessions/week, 60 min/session), while participants in the control group will be asked to maintain their usual lifestyle.
Physical and mental health outcomes will be assessed, including lower and upper-body muscular function, physical function, cardiorespiratory function, anthropometry and body composition, health-related quality of life, cognitive performance, anxiety and depression status, physical activity and sedentary behavior, sleep, biochemical markers, motivators and barriers to exercise, individual's psychological needs, and level of self-determination.
Assessments will be conducted at baseline (week 0), mid-intervention (week 12), at the end of the intervention period (week 25), and 24 weeks after the exercise intervention (week 48).
Eligibility Criteria
Inclusion Criteria:People aged between 60 and 75 years old.Being able to speak and read fluent Spanish.Being able to walk independently.Being physically able to participate in an exercise program.Having a smartphone and being able to understand and use mobile applications autonomously.Exclusion Criteria:Acute or terminal illness.Myocardial infarction, coronary artery bypass grafting, angioplasty, angina, or other cardiac condition in the past year.Uncontrolled medical problems that the general practitioner considers would preclude patients from undertaking the exercise program (e.g., acute systemic illness such as pneumonia, acute rheumatoid arthritis, and acute or unstable heart failure).Conditions requiring a specialized physical exercise program (e.g., uncontrolled epilepsy, significant neurological disease or impairment, inability to maintain an upright seated position or unable to move independently, multiple sclerosis, cancer, Parkinson's, Alzheimer's, or chronic obstructive pulmonary disease).General practitioner-diagnosed hypertension that has not been controlled.Type I Diabetes or uncontrolled Type II Diabetes.History of major psychiatric illness including schizophrenia, generalized anxiety disorder, or depression according to the DSM-5.Morbid obesity (body mass index >39)Three or more self-reported falls in the last year.Not living in the community (e.g., living in nursing homes).Having participated in an exercise program during the 6 months prior to the study.Diagnosis of COVID-19 with hospitalization in intensive care unit.Any other consideration that interferes with the study aims and could be a risk to the participant, at the discretion of the researcher and the general practitioner.
Source: ClinicalTrials.gov (NCT05619250). StuddyBuddy aggregates publicly available trial information.