AzTrials
AzTrials

Physical FunctionExerMOT-NHNCT06352749

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

A study testing Advice to increase physical activity and reduce sedentary behavior, Online Physical Exercise and Face-to-Face Exercise in people with Physical Function and Cognitive Decline, run by University of the Basque Country (UPV/EHU) at 4 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
What is being tested?
Advice to increase physical activity and reduce sedentary behavior, Online Physical Exercise and Face-to-Face Exercise
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
4 sitesSpain
Study dates
18 Mar 2024to 30 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

Jon Irazusta, Prof contact

+34946012837

jon.irazusta@ehu.eus

Ana Rodriguez, Prof contact

34946012846

ana.rodriguez@ehu.eus

Spain4 sites, 4 recruiting

  • Fundación Miranda

    Barakaldo, Vizcaya, 48902

    Celia Gómez, 944382675, innovación@fundaciónmiranda.org

    Not yet recruiting

  • Residencia Aspaldiko

    Portugalete, Bizkaia, 48920

    Alvaro Mosquera, 34-946250000, amosquera@aspaldiko.org

    Recruiting

  • Residencia Nuestra Señora de Begoña

    Santurtzi, Bizkaia, 48980

    Janire R Ochoa, 944836875, psicologa@residencia-santurtzi.com

    Not yet recruiting

  • Residencia Albiz Santiago LLanos

    Sestao, Bizkaia, 48910

    Olatz Larrinaga, 946572220, direccion@residenciaalbiz.eus

    Not yet recruiting

Other trials in Spain

About this study

Official title: 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

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.

Being tested
Advice to increase physical activity and reduce sedentary behavior, Online Physical Exercise, Face-to-Face Exercise
Keywords
physical exercise, online, nursing homes, older adults
Medical subject headings
Cognitive Dysfunction, Psychological Well-Being, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Advice to increase physical activity and reduce sedentary behaviorBehavioural

    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 ExerciseBehavioural

    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 ExerciseBehavioural

    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.

Study groups in NCT06352749
Study groupRoleWhat they receive
ControlSham comparatorParticipants will receive advice to be physically active and to reduce their sedentary behavior
Receives: Behavioral: Advice to increase physical activity and reduce sedentary behavior
Online exerciseExperimentalParticipants 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.
Receives: Behavioral: Advice to increase physical activity and reduce sedentary behavior; Behavioral: Online Physical Exercise
Face-to-face exerciseActive comparatorParticipants 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.
Receives: Behavioral: Advice to increase physical activity and reduce sedentary behavior; Behavioral: Face-to-Face Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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.

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

  3. 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.

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

Secondary outcomes (59)

  1. MoCA (Montreal Cognitive Assessment)

    MoCA test will be used to evaluate the cognitive function of participants. The MoCA was designed as a rapid screening instrument for mild cognitive dysfunction (63). It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score ranged from 0 to 30. Higher scores indicate better performance.

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

  2. Wechsler Adult Intelligence Scale III (WAIS-III)

    The WAIS-III is a test battery that has long been the gold standard for the evaluation of cognitive abilities (69). Specifically, we only use the digit span to evaluate working memory (70). Participants will be asked to recall a list of numbers in the order that they will be given (forward or backwards). The test is finished when for the same item the participant fails two attempts. A total number of correct answers will be registered for each condition. Higher values indicate better performance.

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

  3. EuroQol-5 dimensions (EQ-5D-5L)

    European Quality of Life-5 Dimensions (EQ-5D) questionnaire. Participants will self-rate their health on a vertical visual analogue scale (score range: 0-100), where the endpoints are labeled 'The worst health you can imagine' and 'The best health you can imagine'. Higher values indicate better quality of life.

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

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

    The BPNES will be used to evaluate the satisfaction of the needs perceived by the participants (73). This questionnaire includes 12 items distributed in three dimensions (autonomy, competence and the other four items measure the relationship). The score ranges from 12 to 60. Higher values indicates a greater fulfillment of basic needs in physical exercise.

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

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

    The Zung Anxiety Scale is a self-report questionnaire to measure the severity of anxiety symptoms in individuals. It consists of 20 questions related to various aspects of anxiety, such as physical symptoms, cognitive aspects, and emotional manifestations. Respondents rate each item based on how frequently they experience each symptom. The scale provides a quantitative assessment of anxiety levels, helping professionals to identify individuals experiencing significant anxiety symptoms and determine appropriate interventions.

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

  6. Satisfaction with Life Scale

    It is a 5-question scale with Likert-type answers of 5 categories that examines de global grade of satisfaction with life. Possible answers go from absolutely untrue (1) to absolutely true (5). A score of 5 to 25 points can be obtained. Higher values indicate better satisfaction with life. The score ranges from 5 to 35. Higher values indicate greater satisfaction.

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

  7. Short Physical Performance Battery (SPPB)

    The SPPB consists of three tasks that evaluate the lower extremities' function: balance, walking speed and sit-to-stand 5 times from a chair. In each task 0 to 4 points can be scored, to obtain a total score between 0 and 12 points. Higher values indicate better function.

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

  8. The Biceps Curl Test

    This requires people to repeatedly lift a 5 lb (2.27 kg) weight (for women) or an 8 lb (3.63 kg) weight (for men) for 30 seconds. The number of lifts is recorded. This reflects upper body strength. Higher values indicate better performance.

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

  9. The 2-minute Walk Test (2-MWT)

    2-MWT is an adaptation of 6-MWT. The test measured distance in meters walked in 2 minutes and reflects aerobic endurance. The original version of the Senior Fitness Test required people to walk on a rectangular course but more recent versions use a straight line. Higher values indicate better performance.

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

  10. The 8 Feet Up-and-Go test

    The test measures the time the subject needs to stand from a chair, walk 8 feet (2,5 meters), turn around, get back to the chair, and sit. The longer the time to complete the test, the worse the performance. Leaning on the thighs or the chair is allowed to stand. Lower time indicates better performance.

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

  11. Handgrip strength test

    The grip strength of each hand will be measured with a manual dynamometer. This variable is related to the general strength of the subject, where higher values indicate greater strength

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

  12. Serum Brain Derived Neurotrophic Factor (BDNF)

    Blood samples will be collected in the morning after an overnight fast and at least 24 h after the last exercise session. After collection, tubes will be centrifuged at 5000 rpm for 10 min. Serum obtained for each participant will be stored in aliquots at -80 °C until analysis. Serum BDNF (ng/mL) will be quantified using a sandwich enzyme-linked immunosorbent assay (ELISA). Human BDNF Quantikine Immunoassay (R

    \&D Systems, Minneapolis, MN) will be performed according to the manufacturer's instructions. Results will be reported as ng/mL.

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

  13. Serum Klotho

    Blood samples will be collected in the morning following an overnight fast. Following collection, the tubes will be centrifuged at 5000×g for 10 min. The serum obtained from each participant will be stored in aliquots at - 80 °C for further analysis. A commercial enzyme-linked immunosorbent assay (ELISA) will be performed to measure klotho serum concentration according to the manufacturer's protocol (Human soluble α-Klotho Assay Kit JP27998, Immuno-Biological Laboratories Co., Ltd., Gunma, Japan). The quantification will be performed spectrophotometrically using a FLUOstar OPTIMA Microplate Reader (ThermoFisher Scientific, Waltham, MA, USA) and Optima Control software version 2.20. Results will be reported as ng/mL.

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

  14. Serum Glucose

    Blood samples will be collected in the morning following an overnight fast. The glucose concentration (mg/dL) will be measured in blood serum using routine clinical techniques.

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

  15. Serum Urea

    Blood samples will be collected in the morning following an overnight fast. The urea concentration (mg/dl) will be measured in blood serum using routine clinical techniques.

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

  16. Serum Creatinine

    Blood samples will be collected in the morning following an overnight fast. The concentration (mg/dL) will be measured in blood serum using routine clinical techniques.

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

  17. Serum Uric Acid

    Blood samples will be collected in the morning following an overnight fast. The uric acid concentration (mg/dL) will be measured in blood serum using routine

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

  18. Serum Cholesterol

    Blood samples will be collected in the morning following an overnight fast. The cholesterol concentration (mg/dL) will be measured in blood serum using routine clinical techniques.

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

  19. Serum Triglycerides

    Blood samples will be collected in the morning following an overnight fast. The triglyceride concentration (mg/dL) will be measured in blood serum using routine clinical techniques.

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

  20. Serum HDL-Cholesterol

    Blood samples will be collected in the morning following an overnight fast. The HDL-Cholesterol concentration (mg/dL) will be measured in blood serum using routine clinical techniques.

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

  21. Serum LDL-Cholesterol

    Blood samples will be collected in the morning following an overnight fast. The LDL-Cholesterol concentration (mg/dL) will be measured in blood serum using routine clinical techniques.

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

  22. Serum Glutamate Pyruvate Transaminase

    Blood samples will be collected in the morning following an overnight fast. Serum glutamate pyruvate transaminase activity will be measured in blood serum using routine clinical techniques.

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

  23. Serum Glutamate Oxaloacetate Transaminase

    Blood samples will be collected in the morning following an overnight fast. The glutamate oxaloacetate transaminase activity will be measured in blood serum using routine clinical techniques.

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

  24. Serum gamma glutamyl transferase

    Blood samples will be collected in the morning following an overnight fast. The gamma glutamyl transferase activity will be measured in blood serum using routine clinical techniques.

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

  25. Serum Alkaline Phosphatase

    Blood samples will be collected in the morning following an overnight fast. The alkaline phosphatase activity will be measured in blood serum using routine clinical techniques.

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

  26. Serum Creatin Kinase

    Blood samples will be collected in the morning following an overnight fast. The creatin kinase activity will be measured in blood serum using routine clinical techniques.

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

  27. Serum Lactate Dehydrogenase

    Blood samples will be collected in the morning following an overnight fast. The lactate dehydrogenase activity will be measured in blood serum using routine clinical techniques.

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

  28. Serum Bilirubin

    Blood samples will be collected in the morning following an overnight fast. The bilirubin concentration (mg/dL) will be measured in blood serum using routine clinical techniques.

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

  29. Serum Sodium

    Blood samples will be collected in the morning following an overnight fast. The sodium concentration (mEq/L) will be measured in blood serum using routine clinical techniques.

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

  30. Serum Potassium

    Blood samples will be collected in the morning following an overnight fast. The potassium concentration (mEq/L) will be measured in blood serum using routine clinical techniques.

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

  31. Serum Chloride

    Blood samples will be collected in the morning following an overnight fast. The chloride concentration (mEq/L) will be measured in blood serum using routine clinical techniques.

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

  32. Serum C Reactive Protein

    Blood samples will be collected in the morning following an overnight fast. The C reactive protein concentration (mg/dL) will be measured in blood serum using routine clinical techniques.

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

  33. Serum Albumin

    Blood samples will be collected in the morning following an overnight fast. The albumin concentration (g/dL) will be measured in blood serum using routine clinical techniques

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

  34. Serum Total Protein

    Blood samples will be collected in the morning following an overnight fast. The total protein concentration (g/L) will be measured in blood serum using routine clinical techniques

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

  35. Serum Calcium

    Blood samples will be collected in the morning following an overnight fast. The calcium concentration (mg/dL) will be measured in blood serum using routine clinical techniques

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

  36. Serum Phosphorus

    Blood samples will be collected in the morning following an overnight fast. The phosphorus concentration (mg/dL) will be measured in blood serum using routine clinical techniques

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

  37. Serum D Vitamin

    Blood samples will be collected in the morning following an overnight fast. The D vitamin concentration (ng/dL) will be measured in blood serum using routine clinical techniques

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

  38. Erythrocyte count

    Blood samples will be collected in the morning following an overnight fast. The number of erythrocytes will be measured in blood using routine clinical techniques

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

  39. Hemoglobin

    Blood samples will be collected in the morning following an overnight fast. The hemoglobin concentration will be measured in blood using routine clinical techniques

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

  40. Hematocrit

    Blood samples will be collected in the morning following an overnight fast. The hematocrit will be calculated in blood using routine clinical techniques

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

  41. Mean Corpuscular Volume (MCV)

    Blood samples will be collected in the morning following an overnight fast. The mean corpuscular volume will be measured in blood using routine clinical techniques

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

  42. Mean Corpuscular Hemoglobin (MCH)

    Baseline blood samples will be collected in the morning following an overnight fast. The mean corpuscular hemoglobin will be measured in blood using routine clinical techniques.

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

  43. Mean Corpuscular Hemoglobin Concentration (MCHC)

    Blood samples will be collected in the morning following an overnight fast. The mean corpuscular hemoglobin concentration will be measured in blood using routine clinical techniques

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

  44. Red Cell Distribution Width (RDW)

    Blood samples will be collected in the morning following an overnight fast. The red cell distribution width will be measured in blood using routine clinical techniques

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

  45. Leucocyte Count

    Blood samples will be collected in the morning following an overnight fast. The number of leucocytes will be measured in blood using routine clinical techniques

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

  46. Neutrophil Count and Percentage

    Blood samples will be collected in the morning following an overnight fast. The number of neutrophils will be measured in blood using routine clinical techniques. The percentage of neutrophils in the total white blood cell count will be calculated.

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

  47. Lymphocyte Count and Percentage

    Blood samples will be collected in the morning following an overnight fast. The number of lymphocytes will be measured in blood using routine clinical techniques. The percentage of lymphocytes in the total white blood cell count will be calculated.

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

  48. Monocyte Count and Percentage

    Blood samples will be collected in the morning following an overnight fast. The number of monocytes will be measured in blood using routine clinical techniques. The percentage of monocytes in the total white blood cell count will be calculated

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

  49. Eosinophil Count and Percentage

    Blood samples will be collected in the morning following an overnight fast. The number of eosinophils will be measured in blood using routine clinical techniques. The percentage of eosinophils in the total white blood cell count will be calculated

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

  50. Basophil Count and Percentage

    Blood samples will be collected in the morning following an overnight fast. The number of basophils will be measured in blood using routine clinical techniques. The percentage of basophils in the total white blood cell count will be calculated

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

  51. Platelet Count

    Blood samples will be collected in the morning following an overnight fast. The number of platelets will be measured in blood using routine clinical techniques.

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

  52. Platelet Mean Volumen

    Blood samples will be collected in the morning following an overnight fast. The mean volume of platelets will be measured in blood using routine clinical techniques.

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

  53. Physical activity, sedentary lifestyle and sleep will be evaluate using accelerometry

    Physical activity level was recorded with an accelerometer (Actigraph GT3X model; Actigraph LLC, Pensacola, FL, USA) that participants wore on the wrist with a belt for 7 days. Participants did not receive additional instructions to walk during the assessment period. The accelerometer was set to record the number of steps taken per day. Active-period intensities were classified as light, moderate, or vigorous, and were measured in minutes per day at each intensity. Sedentary time, bouts and breaks will be also recorded.

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

  54. Fried's frailty phenotype score

    Frailty will be analyzed with the 5 criteria suggested by Fried: unintentional weight loss, weakness or poor handgrip strength, self-reported exhaustion, slow walking speed, and low physical activity. The presence of each criterion will be scored with one point, the total score ranging between 0-5 points. A higher score indicates higher frailty.

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

  55. Frail-NH frailty scale

    It consist of 6 items Fatigue, resistance, ambulation, nutritional approach and help with dressing. Each item could receive a score from 0 to 2 and total score ranges from 0 to 13. An score < 6 is defined as non-frail; 6-7 as prefrail and > 7 as frail.

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

  56. The Pittsburgh Sleep Quality Index

    The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. The Score ranges from 0 to 21. Higher values indicate worse sleep.

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

  57. Attendance rate

    Attendance rate to face-to-face sessions will be calculated as the percentage of sessions attended out of the actual number of sessions offered. Reasons for non-attendance will be also provided

    Measured: During 24 weeks of intervention

  58. Dose modification

    Dose modifications (intensity or volume) in each session will be recorded. The number and percentage of dose modification will be calculated and provided.

    Measured: During 24 weeks of intervention

  59. Adverse Events

    Adverse events (safety and technical) in each session will be recorded. The number and percentage of each type of adverse event will be calculated and provided.

    Measured: During 24 weeks of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2024
  2. Study start18 Mar 2024
  3. Primary completion30 Nov 2025 (estimated)
  4. Study completion30 Nov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Each group will be assigned to control, online intervention or face-to-face intervention
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06352749
Sponsor's protocol ID
BasqueCU2024
Acronym
ExerMOT-NH
Status last verified
Apr 2024
First submitted
17 Mar 2024
Last updated
8 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The anonymized data may be shared, following a reasoned proposal

Publications

  • 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.

    PubMed 26318386

  • 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.

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

  • 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.

    PubMed 15817019

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

  • 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.

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Questions about this trial

What is this clinical trial studying?

A study testing Advice to increase physical activity and reduce sedentary behavior, Online Physical Exercise and Face-to-Face Exercise in people with Physical Function and Cognitive Decline, run by University of the Basque Country (UPV/EHU) at 4 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jon Irazusta, Prof (+34946012837, jon.irazusta@ehu.eus), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Trail Making Test (TMT) (time frame: At baseline, after 24 weeks of intervention and after 24 weeks follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06352749, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.

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