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

NCT ID: NCT06352749

Last Updated: 2024-04-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-18
• Study Completion Date: 2025-11-30

Brief Summary

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.

Conditions

Physical Function; Cognitive Decline; Psychological Well-Being

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Control

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

Group Type: SHAM_COMPARATOR

Advice to increase physical activity and reduce sedentary behavior

Intervention Type: BEHAVIORAL

After the baseline assessments, all participants will receive individualized counseling for following physically active lifestyle and reducing sedentary behaviors. Participants will be encouraged to increase the physical activity time and intensity, and to hourly break the sedentary time while at home. The recommendations will be transmitted verbally and through written material.

Online exercise

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.

Group Type: EXPERIMENTAL

Advice to increase physical activity and reduce sedentary behavior

Intervention Type: BEHAVIORAL

After the baseline assessments, all participants will receive individualized counseling for following physically active lifestyle and reducing sedentary behaviors. Participants will be encouraged to increase the physical activity time and intensity, and to hourly break the sedentary time while at home. The recommendations will be transmitted verbally and through written material.

Online Physical Exercise

Intervention Type: BEHAVIORAL

This intervention will entail:

Strength training of upper and lower limbs. Familiarization phase will include 2-3 exercises of 1-2 series and 8-12 repetitions per session. During the acquisition phase, 2-3 exercises of 2-3 series and 8-12 repetitions at a higher velocity. The resting time between sets will be of 1-3 minutes.

Balance exercises will include proprioception, agility and weight transfer exercises. Difficulty will progressively increase by reducing the base of support, by including multidirectional displacements, walking on tiptoe or heels, body-weight transfer, dynamic exercises modifying the centre of gravity, and stressing postural muscles and by sensorial reductions.

Flexibility exercises: Static stretching maintained during 20-30s carried out at the end of each session.

All the sessions will be supervised online by trained physiotherapists or sports physiologists.

Face-to-face exercise

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.

Group Type: ACTIVE_COMPARATOR

Advice to increase physical activity and reduce sedentary behavior

Intervention Type: BEHAVIORAL

After the baseline assessments, all participants will receive individualized counseling for following physically active lifestyle and reducing sedentary behaviors. Participants will be encouraged to increase the physical activity time and intensity, and to hourly break the sedentary time while at home. The recommendations will be transmitted verbally and through written material.

Face-to-Face Exercise

Intervention Type: BEHAVIORAL

This intervention will entail:

Strength training of upper and lower limbs. Familiarization phase will include 2-3 exercises of 1-2 series and 8-12 repetitions per session. During the acquisition phase, 2-3 exercises of 2-3 series and 8-12 repetitions at a higher velocity. The resting time between sets will be of 1-3 minutes.

Balance exercises will include proprioception, agility and weight transfer exercises. Difficulty will progressively increase by reducing the base of support, by including multidirectional displacements, walking on tiptoe or heels, body-weight transfer, dynamic exercises modifying the centre of gravity, and stressing postural muscles and by sensorial reductions.

Flexibility exercises: Static stretching maintained during 20-30s carried out at the end of each session.

All the sessions will be supervised face-to-face by trained physiotherapists or sports physiologists.

Interventions

Advice to increase physical activity and reduce sedentary behavior

After the baseline assessments, all participants will receive individualized counseling for following physically active lifestyle and reducing sedentary behaviors. Participants will be encouraged to increase the physical activity time and intensity, and to hourly break the sedentary time while at home. The recommendations will be transmitted verbally and through written material.

Intervention Type: BEHAVIORAL

Online Physical Exercise

This intervention will entail:

Strength training of upper and lower limbs. Familiarization phase will include 2-3 exercises of 1-2 series and 8-12 repetitions per session. During the acquisition phase, 2-3 exercises of 2-3 series and 8-12 repetitions at a higher velocity. The resting time between sets will be of 1-3 minutes.

Balance exercises will include proprioception, agility and weight transfer exercises. Difficulty will progressively increase by reducing the base of support, by including multidirectional displacements, walking on tiptoe or heels, body-weight transfer, dynamic exercises modifying the centre of gravity, and stressing postural muscles and by sensorial reductions.

Flexibility exercises: Static stretching maintained during 20-30s carried out at the end of each session.

All the sessions will be supervised online by trained physiotherapists or sports physiologists.

Intervention Type: BEHAVIORAL

Face-to-Face Exercise

This intervention will entail:

Strength training of upper and lower limbs. Familiarization phase will include 2-3 exercises of 1-2 series and 8-12 repetitions per session. During the acquisition phase, 2-3 exercises of 2-3 series and 8-12 repetitions at a higher velocity. The resting time between sets will be of 1-3 minutes.

Balance exercises will include proprioception, agility and weight transfer exercises. Difficulty will progressively increase by reducing the base of support, by including multidirectional displacements, walking on tiptoe or heels, body-weight transfer, dynamic exercises modifying the centre of gravity, and stressing postural muscles and by sensorial reductions.

Flexibility exercises: Static stretching maintained during 20-30s carried out at the end of each session.

All the sessions will be supervised face-to-face by trained physiotherapists or sports physiologists.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundación Miranda

UNKNOWN

Sponsor Role: collaborator

Residencia Albiz Santiago Llanos

UNKNOWN

Sponsor Role: collaborator

Aspaldiko

UNKNOWN

Sponsor Role: collaborator

Residencia Nuestra Señora de Begoña, Santurtzi

UNKNOWN

Sponsor Role: collaborator

University of the Basque Country (UPV/EHU)

OTHER

Sponsor Role: lead

Responsible Party

Jon Irazusta

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jon Irazusta, Prof

Role: PRINCIPAL_INVESTIGATOR

University of the Basque Country (UPV/EHU)

Locations

Residencia Aspaldiko

Portugalete, Bizkaia, Spain

Site Status: RECRUITING

Residencia Nuestra Señora de Begoña

Santurtzi, Bizkaia, Spain

Site Status: NOT_YET_RECRUITING

Residencia Albiz Santiago LLanos

Sestao, Bizkaia, Spain

Site Status: NOT_YET_RECRUITING

Fundación Miranda

Barakaldo, Vizcaya, Spain

Site Status: NOT_YET_RECRUITING

Countries

Spain

Central Contacts

Jon Irazusta, Prof

Role: CONTACT

jon.irazusta@ehu.eus

+34946012837

Ana Rodriguez, Prof

Role: CONTACT

ana.rodriguez@ehu.eus

34946012846

Facility Contacts

Alvaro Mosquera

Role: primary

amosquera@aspaldiko.org

34-946250000

Janire R Ochoa

Role: primary

psicologa@residencia-santurtzi.com

944836875

Olatz Larrinaga

Role: primary

direccion@residenciaalbiz.eus

946572220

Celia Gómez

Role: primary

innovación@fundaciónmiranda.org

944382675

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Other Identifiers

BasqueCU2024

Identifier Type: -

Identifier Source: org_study_id