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

NCT06352749 | Recruiting

• 1 other identifier: BasqueCU2024
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

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

Keywords

physical exercise; online; nursing homes; older adults

Outcome Measures

Primary Outcomes (3)

• Trail Making Test (TMT)

  The TMT is a valid and widely used test to assess executive functioning. The TMT consists of two parts, part A and part B. Part A is based on number sequencing and assesses visual-perceptual abilities and participants have to draw lines to link numbers from 1 to 25 in ascending order. Part B focus on number and letter switching evaluates cognitive flexibility and consists of drawing a line to link the numbers and the letters alternatively following in ascending order (e.g. 1-A-2-B-3-C). The completion time will be registered in seconds. Lower duration indicates better performance

  At baseline, after 24 weeks of intervention and after 24 weeks follow-up

• Spanish Version of the Yesavage Depression Scale

  The Yesavage Depression Scale, also known as the Geriatric Depression Scale (GDS), is a widely used self-report questionnaire designed to detect symptoms of depression in older adults. it consists 15 simple yes/no questions focusing on mood, cognition, and behavior. The scale helps assess the severity of depressive symptoms and can aid in determining the need for further evaluation or intervention. The scores range from 0 to 15. Higher values indicate more depressive symptoms.

  At baseline, after 24 weeks of intervention and after 24 weeks follow-up

• 30-seconds Chair Sit to Stand test

  A test to measure muscle function of the lower limbs. Starting in a seated position, participants will be instructed to perform as many full sit-to-stand cycles as they could in a 30-second timeframe with the number of cycles considered the score for this test. Higher scores indicate better performance.

  At baseline, after 24 weeks of intervention and after 24 weeks follow-up

Secondary Outcomes (59)

• MoCA (Montreal Cognitive Assessment)

  At baseline, after 24 weeks of intervention and after 24 weeks follow-up

• Wechsler Adult Intelligence Scale III (WAIS-III)

  At baseline, after 24 weeks of intervention and after 24 weeks follow-up

• EuroQol-5 dimensions (EQ-5D-5L)

  At baseline, after 24 weeks of intervention and after 24 weeks follow-up

• The Spanish adaptation of the Basic Psychological Needs in Exercise Scale (BPNES) (Moreno et al., 2008)

  At baseline, after 24 weeks of intervention and after 24 weeks follow-up

• Zung's Anxiety Self-Assessment Scale (Hernández-Pozo, et al., 2008)

  At baseline, after 24 weeks of intervention and after 24 weeks follow-up

Study Arms (3)

Control

SHAM COMPARATOR

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

Behavioral: Advice to increase physical activity and reduce sedentary behavior

Online exercise

EXPERIMENTAL

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.

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

Face-to-face exercise

ACTIVE COMPARATOR

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.

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

Interventions

Advice to increase physical activity and reduce sedentary behavior 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.

Control; Face-to-face exercise; Online exercise

Online Physical Exercise 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.

Online exercise

Face-to-Face Exercise 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.

Face-to-face exercise

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of the Basque Country (UPV/EHU): lead
• Fundación Miranda: collaborator
• Residencia Albiz Santiago Llanos: collaborator
• Aspaldiko: collaborator
• Residencia Nuestra Señora de Begoña, Santurtzi: collaborator

Study Sites (4)

Residencia Aspaldiko

Portugalete, Bizkaia, 48920, Spain

RECRUITING

Residencia Nuestra Señora de Begoña

Santurtzi, Bizkaia, 48980, Spain

NOT YET RECRUITING

Residencia Albiz Santiago LLanos

Sestao, Bizkaia, 48910, Spain

NOT YET RECRUITING

Fundación Miranda

Barakaldo, Vizcaya, 48902, Spain

NOT YET RECRUITING

Related Publications (16)

• Llinas-Regla J, Vilalta-Franch J, Lopez-Pousa S, Calvo-Perxas L, Torrents Rodas D, Garre-Olmo J. The Trail Making Test. Assessment. 2017 Mar;24(2):183-196. doi: 10.1177/1073191115602552. Epub 2016 Jul 28.

  PMID: 26318386 BACKGROUND

• Martínez de la Iglesia J, Onís-Vilches MC, Dueñas-Herrero R, et ál. Versión española del cuestionario de Yesavage abreviado (GDS) para el despistaje de depresión en mayores de 65 años: adaptación y validación. Medifam. 2002; 12(10):620.

  BACKGROUND

• Rikli, R.E., Jones, C.J. Senior Fitness Test. Champaign: Human Kinetics; 2001. (ISBN 0-7360- 3356-3364).

  BACKGROUND

• Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

  PMID: 15817019 BACKGROUND

• Wechsler D. WAIS III: escala de inteligencia de Wechsler para adultos-III manual técnico. Madrid: TEA; 1999

  BACKGROUND

• Herdman M, Badia X, Berra S. [EuroQol-5D: a simple alternative for measuring health-related quality of life in primary care]. Aten Primaria. 2001 Oct 15;28(6):425-30. doi: 10.1016/s0212-6567(01)70406-4. No abstract available. Spanish.

  PMID: 11602124 BACKGROUND

• Moreno, J. A., González-Cutre, D., Chillón, M., y Parra, N. (2008). Adaptación a la educación física de la escala de las necesidades psicológicas básicas en el ejercicio. Revista Mexicana de Psicología, 25(2), 295-303

  BACKGROUND

• Hernández-Pozo, M., Macías, D., Calleja, N., Cerezo, S., & del Valle Chauvet, C. (2008). Propiedades psicometricas del inventario Zung del estado de ansiedad con mexicanos. Psychologia. Avances de la disciplina, 2(2), 19-46.

  BACKGROUND

• Vazquez C, Duque A, Hervas G. Satisfaction with life scale in a representative sample of Spanish adults: validation and normative data. Span J Psychol. 2013;16:E82. doi: 10.1017/sjp.2013.82.

  PMID: 24230945 BACKGROUND

• Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.

  PMID: 8126356 BACKGROUND

• Pin TW. Psychometric properties of 2-minute walk test: a systematic review. Arch Phys Med Rehabil. 2014 Sep;95(9):1759-75. doi: 10.1016/j.apmr.2014.03.034. Epub 2014 May 9.

  PMID: 24814460 BACKGROUND

• Fess EE. Grip strength. In: Casanova JS, editor. Clinical assessment recommendations, 2nd ed. Chicago: American Society of Hand Therapists; 1992. pp. 41-45.

  BACKGROUND

• Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

  PMID: 11253156 BACKGROUND

• Kaehr E, Visvanathan R, Malmstrom TK, Morley JE. Frailty in nursing homes: the FRAIL-NH Scale. J Am Med Dir Assoc. 2015 Feb;16(2):87-9. doi: 10.1016/j.jamda.2014.12.002. Epub 2014 Dec 31. No abstract available.

  PMID: 25556303 BACKGROUND

• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

  PMID: 2748771 BACKGROUND

• Rodriguez-Larrad A, Arrieta H, Rezola C, Kortajarena M, Yanguas JJ, Iturburu M, Susana MG, Irazusta J. Effectiveness of a multicomponent exercise program in the attenuation of frailty in long-term nursing home residents: study protocol for a randomized clinical controlled trial. BMC Geriatr. 2017 Feb 23;17(1):60. doi: 10.1186/s12877-017-0453-0.

  PMID: 28231827 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Psychological Well-Being; Motor Activity

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• Jon Irazusta, Prof

  University of the Basque Country (UPV/EHU)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jon Irazusta, Prof

CONTACT

+34946012837; jon.irazusta@ehu.eus

Ana Rodriguez, Prof

CONTACT

34946012846; ana.rodriguez@ehu.eus

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigators in charge of doing the statistical analysis and assessing the outcome measures will be blinded to group allocation. Due to the characteristics of the study, blinding the participants and the care provider (i.e., the professional conducting the exercise sessions) to the group allocation is not possible.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Each group will be assigned to control, online intervention or face-to-face intervention

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: April 8, 2024
• Study Start: March 18, 2024
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Access Criteria: The protocol data may be shared, following a reasoned proposal

Locations

ES (4)