Face-to-face vs Online Physical Exercise in Seniors Living in Nursing Homes (ExerMOT-NH)

University of the Basque Country (UPV/EHU)

Status: Enrolling

Conditions: Physical Function; Psychological Well-Being; Cognitive Decline

Treatments: Behavioral: Advice to increase physical activity and reduce sedentary behavior; Behavioral: Online Physical Exercise; Behavioral: Face-to-Face Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06352749

BasqueCU2024

Details and patient eligibility

About

The benefits of multicomponent physical exercise (MPE) in the mental and physical health of older adults are widely accepted. However, during Covid19 pandemic, some face-to-face programs for physical exercise were canceled. The situation was particularly complex in nursing homes (NHs) because residents were often confined to their floors and many leisure activities were canceled. Online physical exercise sessions increased their popularity during the pandemic. However, there is no evidence that online physical exercise sessions are an effective alternative to face-to-face sessions for older people living in NHs. The current project aims to assess a synchronous online MPE program's feasibility, acceptability, and effects. With this aim, first a synchronous online MPE intervention was designed and then a multicenter randomized controlled trial with 3 branches was developed: face-to-face MPE, online MPE and control. Participants in the control group will receive advice to maintain physical activity and reduce sedentary behavior. Additionally, those in the intervention groups will also participate in 24-week individualized and progressive MPE programs performed at moderate intensity that will be focused on strength, balance, and endurance. MPE will be performed through supervised sessions (2 per week). One of the intervention groups will be supervised face-to-face whereas the other will be supervised synchronously online. Study assessments will be conducted at baseline, at the end of the 24-week intervention, and after 24-week follow-up. The primary outcomes of the study will be changes in mental and physical health. Secondary outcomes will include other parameters of mental and physical health, together with physical activity, frailty, quality of life, and biological markers. The dropout rate, the adherence, the injuries and other adverse events suffered by the participants, and technical incidences produced in the online modality will be recorded. A mixed-model ANCOVA will be performed to compare the data between intervention and control groups, considering as co-variables baseline measurements. The statistical analysis will be performed on the whole sample and separated for sex/gender. The study received ethical approval (M10_2022_405_IRAZUSTA ASTIAZARAN). The results of this project will be transferred to institutions and entities involved in managing NHs to increase the opportunities for the residents to remain physically active.

Enrollment: 120 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Older than 65 years
• A score equal to or higher than 15 out of 35 in the MEC-35 (Miniexamen Cognoscitivo) cognitive test
• A score equal to or higher than 50 out of 100 in the Barthel Index
• Able to stand-up and walk for 10 meters

Exclusion criteria

• Unstable Clinical Situation
• When the potential harms outweigh the benefits, according to the judgment of the healthcare personnel at the NHs

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

Control

Sham Comparator group

Description:

Participants will receive advice to be physically active and to reduce their sedentary behavior

Treatment:

Behavioral: Advice to increase physical activity and reduce sedentary behavior

Online exercise

Experimental group

Description:

Participants will receive general recommendations for maintaining physically active and reducing sedentary behaviors. This will be done verbally and through written material. In addition, participants will take part in a 6-month multicomponent physical exercise program consisting of 2 online weekly multicomponent sessions.

Treatment:

Behavioral: Online Physical Exercise

Behavioral: Advice to increase physical activity and reduce sedentary behavior

Face-to-face exercise

Active Comparator group

Description:

Participants will receive general recommendations for maintaining physically active and reducing sedentary behaviors. This will be done verbally and through written material. In addition, participants will take part in a 6-month multicomponent physical exercise program consisting of 2 face-to-face weekly multicomponent sessions.

Treatment:

Behavioral: Face-to-Face Exercise

Behavioral: Advice to increase physical activity and reduce sedentary behavior