Face-to-face vs Online Physical Exercise in Seniors Living in Nursing Homes: Randomized Controlled Trial on Its Effects on Health and Quality of Life
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Physical Function
- Sponsor
- University of the Basque Country (UPV/EHU)
- Enrollment
- 120
- Locations
- 4
- Primary Endpoint
- 30-seconds Chair Sit to Stand test
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Jon Irazusta
Professor
University of the Basque Country (UPV/EHU)
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
Outcomes
Primary Outcomes
30-seconds Chair Sit to Stand test
Time Frame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
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.
Spanish Version of the Yesavage Depression Scale
Time Frame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
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.
Trail Making Test (TMT)
Time Frame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up
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
Secondary Outcomes
- Short Physical Performance Battery (SPPB)(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- The 2-minute Walk Test (2-MWT)(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)
- Zung's Anxiety Self-Assessment Scale (Hernández-Pozo, et al., 2008)(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Satisfaction with Life Scale(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- The 8 Feet Up-and-Go test(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Serum Triglycerides(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Serum Glutamate Pyruvate Transaminase(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Serum Potassium(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Serum Calcium(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Hemoglobin(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- MoCA (Montreal Cognitive Assessment)(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)
- Serum Uric Acid(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Serum Cholesterol(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)
- Serum Brain Derived Neurotrophic Factor (BDNF)(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Serum LDL-Cholesterol(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Serum D Vitamin(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Mean Corpuscular Hemoglobin (MCH)(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- The Biceps Curl Test(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Serum Glucose(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Serum Urea(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Serum Creatin Kinase(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Serum Lactate Dehydrogenase(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Serum Bilirubin(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Serum Total Protein(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Leucocyte Count(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Handgrip strength test(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Serum Klotho(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Serum Creatinine(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Serum Glutamate Oxaloacetate Transaminase(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Serum Sodium(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Serum Albumin(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Hematocrit(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Neutrophil Count and Percentage(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Platelet Count(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Serum HDL-Cholesterol(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Serum gamma glutamyl transferase(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Serum Alkaline Phosphatase(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Serum Chloride(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Serum C Reactive Protein(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Serum Phosphorus(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Erythrocyte count(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Mean Corpuscular Volume (MCV)(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Eosinophil Count and Percentage(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Lymphocyte Count and Percentage(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Monocyte Count and Percentage(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Basophil Count and Percentage(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Platelet Mean Volumen(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Physical activity, sedentary lifestyle and sleep will be evaluate using accelerometry(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Adverse Events(During 24 weeks of intervention)
- Mean Corpuscular Hemoglobin Concentration (MCHC)(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Red Cell Distribution Width (RDW)(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Frail-NH frailty scale(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- The Pittsburgh Sleep Quality Index(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Dose modification(During 24 weeks of intervention)
- Fried's frailty phenotype score(At baseline, after 24 weeks of intervention and after 24 weeks follow-up)
- Attendance rate(During 24 weeks of intervention)