Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05895760
Status:
COMPLETED
Last Update Posted:
2023-06-09
First Post:
2023-05-05
Brief Title:
Effectiveness of a Multi-component Physical Exercise Online
Sponsor:
Universidad Iberoamericana AC Mexico
Organization:
Universidad Iberoamericana AC Mexico
Study Overview
Official Title:
Effectiveness of a Multi-component Physical Exercise Online on Physical Performance in Community-dwelling Older Adults a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MEP
Brief Summary:
Objective to assess the effectiveness of a multi-component physical exercise online intervention MPE on physical performance PP in community-dwelling older adults
Methods a randomized controlled trial including 110 older adults 6845554 years were divided into two parallel groups an MPE group n 55 and a control group n 55 The exercise program included endurance strength coordination balance and flexibility exercises which were carried out for 3 months The control group received educational sessions on health prevention related to physical exercise The main endpoint was a change in PP assessed with the short physical performance battery SPPB It is also evaluated other variables such as sociodemographic sex age education level health conditions cognitive impairment polypharmacy comorbidity frailty sarcopenia depressive and anxiety symptoms functional dependence through scales of activities of daily living ADL nutrition risk of malnutrition weight height body mass index BMI calf and waist circumference and lifestyles physical activity alcoholism and smoking Comparisons were made in the follow-up measurements between groups by an independent t-test and baseline and follow-up measurements in both groups by a paired t-test
Methods a randomized controlled trial including 110 older adults 6845554 years were divided into two parallel groups an MPE group n 55 and a control group n 55 The exercise program included endurance strength coordination balance and flexibility exercises which were carried out for 3 months The control group received educational sessions on health prevention related to physical exercise The main endpoint was a change in PP assessed with the short physical performance battery SPPB It is also evaluated other variables such as sociodemographic sex age education level health conditions cognitive impairment polypharmacy comorbidity frailty sarcopenia depressive and anxiety symptoms functional dependence through scales of activities of daily living ADL nutrition risk of malnutrition weight height body mass index BMI calf and waist circumference and lifestyles physical activity alcoholism and smoking Comparisons were made in the follow-up measurements between groups by an independent t-test and baseline and follow-up measurements in both groups by a paired t-test
Detailed Description:
Methods Study design and participants The study was a randomized controlled trial conducted from June to October 2021 The study population was randomly selected from the FraDySMex study Frailty Dynapenia and Sarcopenia in Mexican Adults adults aged 50 years and older The adults were residents of Mexico City from three different municipalities Cuajimalpa Álvaro Obregón and Magdalena Contreras The protocol was approved by the Committee on Ethics in Research of the Iberoamerican University Mexico City with No352020 Informed consent was obtained from each participant who signed it after fully understanding the procedures
The eligibility criteria were the following
Adults 60 and over years
Adults who had an electronic device with internet access for video calls
The exclusion criteria were
Adults self-reported walking disability with the inability to complete the short physical performance battery SPPB
Adults with severe functional dependence defined as a Barthel index 60100 score
Adults with cognitive impairment defined as a mini-mental state examination MMSE score 2430
Adults with terminal illness
Adults who were participation in a physical activity or nutritional program
Adults with a limb loss or use of lower or upper limb prostheses
Adults with a history of injuries fracturesfalls of less than one year in hip knee or ankle joints and with surgery in the last 6 months or contraindications to perform trial activities in the judgment of medical personnel
Adults who presented any medical condition or adverse symptoms during the intervention that made it impossible to carry out the physical exercise program
Adults who did not keep three times consecutive were eliminated from the study
Sample size estimate power calculations The sample size calculation was based on the primary outcome SPPB with power of 80 1-β 2-sided α-error 95 CI 2 groups 2 measurements One hundred participants were required in order to detect a clinically meaningful change of 10 point with a SD of 099 points To account for potential dropouts before study completion we will inflate the sample size by 10 losses during follow-up resulting in a total sample size of 110 individuals 55 participants allocated to each group With a sample of 1000 adults from the FraDySMex study were selected 110 adults and they will be assigned to groups by computer random number generation and were assigned in 11 ratio intervention group and control group It was simple-blind since the participants did not know which they were group Figure 1 shows the population flow diagram
Safety All study staff monitored participant safety and reported three categories of adverse events serious adverse events unexpected adverse events those potentially related to study procedures or activities and not listed in the informed consent form or study protocol and adverse events that occurred while the participant was under the supervision or guidance of study staff
Interventions Intervention group A multicomponent exercise program MEP was implemented consisting of a combined program of endurance strength coordination balance and flexibility exercises depending on the level of functional capacity ie severe moderate and mild limitation The recommendations of the ViviFrail project were followed to form the groups depending on their short physical performance battery SPPB score
Three types of physical exercise programs were designed according to the physical performance level of each participant The first type of exercise program training was performed for frail adults with an SPPB score of 4 to 6 the second was for the pre-frail adults with an SPPB short physical performance battery score of 7 to 9 and the third for robust adults with an SPPB of 10 to 12 The multi-component program was developed with the support of a physical training specialist a medical rehabilitator gerontological nutritionists and geriatrics First warm-up exercises general exercises and return-to-calm exercises were structured for each group an then videos were made to upload the exercise program on a YouTube plataform
To start the intervention a message was sent a few days beforehand to remind about the appointment and the materials for the corresponding session The intervention for each of the participants was carried out individually through the Zoom app or by WhatsApp video call 3 times a week with the supervision of health professionals with a duration per session of 45-60 min At the end of the session the OMNI- RES physical exercise effort scale was applied which has a score from 0 to 10 classified as 0 extremely easy to 10 extremely hard In addition the participants physical fitness and physical activity status were monitored through a series of questions at the beginning of each week of intervention to ensure the older adult was able to continue with the intervention
Control group This group was invited to remote meetings every 15 days in which education on exercise-related health prevention was provided Topics such as benefits of multicomponent exercise for older adults recommendations for physical exercise training in older adults recommendations for an active aging healthy eating for older adults my plate for older adults The physical rehabilitator and gerontological nutritionists were in charge of providing the recommendations and the session lasted approximately In addition they were instructed not to participate in any physical exercise program during the study period and to continue with their usual activitiesThis information is available on the You Tube platform httpswwwyoutubecomnutriciongeriatricavideos
Data collection All data from the baseline and final evaluations were collected through the Zoom app or by WhatsApp video call and using survey monkey
Primary response variable physical performance
Physical performance was assessed with the short physical performance battery SPPB scale which is an instrument that evaluates three domains of physical performance balance gait speed and lower limb strength to rise from a chair Every test has a maximum score of 4 obtaining a maximum score of 12 points if the subject obtains a score 8 points is classified as a person with low physical performance according to Group for the European Working Group on Sarcopenia in Older People 2 EWGSOP2
Covariates
Sociodemographic Age years sex and schooling 10 10 yearsHealth Conditions depressive symptoms were evaluated by the Depression Scale of the Center for Epidemiological Studies CESD-7 cognitive status was assessed using the MMSE test comorbidity through the Charlson comorbidity index frailty was measured using the FRAIL scale a simple frailty questionnaire sarcopenia using the SARC-F scale a screening questionnaire for sarcopenia and medication use It also evaluated functional disability FD using the Barthel scale for the basic activities of daily living BADL and the instrumental activities of daily living IADL Nutrition variables malnutrition was assessed through the Mini Nutritional Assessment MNA test anthropometric measurements such as weight kg height mts BMI body mass index calf waist hip and mild-arm circumferences and body composition as fat mass and free fat mass These measurements were evaluated with an OMRON HBF-514C portable scale capable of assessing a total weight of 150 kg Level of physical activity physical activity was measured using the Physical Activity Survey YPAS questionnaire obtaining weekly METs as a result
The eligibility criteria were the following
Adults 60 and over years
Adults who had an electronic device with internet access for video calls
The exclusion criteria were
Adults self-reported walking disability with the inability to complete the short physical performance battery SPPB
Adults with severe functional dependence defined as a Barthel index 60100 score
Adults with cognitive impairment defined as a mini-mental state examination MMSE score 2430
Adults with terminal illness
Adults who were participation in a physical activity or nutritional program
Adults with a limb loss or use of lower or upper limb prostheses
Adults with a history of injuries fracturesfalls of less than one year in hip knee or ankle joints and with surgery in the last 6 months or contraindications to perform trial activities in the judgment of medical personnel
Adults who presented any medical condition or adverse symptoms during the intervention that made it impossible to carry out the physical exercise program
Adults who did not keep three times consecutive were eliminated from the study
Sample size estimate power calculations The sample size calculation was based on the primary outcome SPPB with power of 80 1-β 2-sided α-error 95 CI 2 groups 2 measurements One hundred participants were required in order to detect a clinically meaningful change of 10 point with a SD of 099 points To account for potential dropouts before study completion we will inflate the sample size by 10 losses during follow-up resulting in a total sample size of 110 individuals 55 participants allocated to each group With a sample of 1000 adults from the FraDySMex study were selected 110 adults and they will be assigned to groups by computer random number generation and were assigned in 11 ratio intervention group and control group It was simple-blind since the participants did not know which they were group Figure 1 shows the population flow diagram
Safety All study staff monitored participant safety and reported three categories of adverse events serious adverse events unexpected adverse events those potentially related to study procedures or activities and not listed in the informed consent form or study protocol and adverse events that occurred while the participant was under the supervision or guidance of study staff
Interventions Intervention group A multicomponent exercise program MEP was implemented consisting of a combined program of endurance strength coordination balance and flexibility exercises depending on the level of functional capacity ie severe moderate and mild limitation The recommendations of the ViviFrail project were followed to form the groups depending on their short physical performance battery SPPB score
Three types of physical exercise programs were designed according to the physical performance level of each participant The first type of exercise program training was performed for frail adults with an SPPB score of 4 to 6 the second was for the pre-frail adults with an SPPB short physical performance battery score of 7 to 9 and the third for robust adults with an SPPB of 10 to 12 The multi-component program was developed with the support of a physical training specialist a medical rehabilitator gerontological nutritionists and geriatrics First warm-up exercises general exercises and return-to-calm exercises were structured for each group an then videos were made to upload the exercise program on a YouTube plataform
To start the intervention a message was sent a few days beforehand to remind about the appointment and the materials for the corresponding session The intervention for each of the participants was carried out individually through the Zoom app or by WhatsApp video call 3 times a week with the supervision of health professionals with a duration per session of 45-60 min At the end of the session the OMNI- RES physical exercise effort scale was applied which has a score from 0 to 10 classified as 0 extremely easy to 10 extremely hard In addition the participants physical fitness and physical activity status were monitored through a series of questions at the beginning of each week of intervention to ensure the older adult was able to continue with the intervention
Control group This group was invited to remote meetings every 15 days in which education on exercise-related health prevention was provided Topics such as benefits of multicomponent exercise for older adults recommendations for physical exercise training in older adults recommendations for an active aging healthy eating for older adults my plate for older adults The physical rehabilitator and gerontological nutritionists were in charge of providing the recommendations and the session lasted approximately In addition they were instructed not to participate in any physical exercise program during the study period and to continue with their usual activitiesThis information is available on the You Tube platform httpswwwyoutubecomnutriciongeriatricavideos
Data collection All data from the baseline and final evaluations were collected through the Zoom app or by WhatsApp video call and using survey monkey
Primary response variable physical performance
Physical performance was assessed with the short physical performance battery SPPB scale which is an instrument that evaluates three domains of physical performance balance gait speed and lower limb strength to rise from a chair Every test has a maximum score of 4 obtaining a maximum score of 12 points if the subject obtains a score 8 points is classified as a person with low physical performance according to Group for the European Working Group on Sarcopenia in Older People 2 EWGSOP2
Covariates
Sociodemographic Age years sex and schooling 10 10 yearsHealth Conditions depressive symptoms were evaluated by the Depression Scale of the Center for Epidemiological Studies CESD-7 cognitive status was assessed using the MMSE test comorbidity through the Charlson comorbidity index frailty was measured using the FRAIL scale a simple frailty questionnaire sarcopenia using the SARC-F scale a screening questionnaire for sarcopenia and medication use It also evaluated functional disability FD using the Barthel scale for the basic activities of daily living BADL and the instrumental activities of daily living IADL Nutrition variables malnutrition was assessed through the Mini Nutritional Assessment MNA test anthropometric measurements such as weight kg height mts BMI body mass index calf waist hip and mild-arm circumferences and body composition as fat mass and free fat mass These measurements were evaluated with an OMRON HBF-514C portable scale capable of assessing a total weight of 150 kg Level of physical activity physical activity was measured using the Physical Activity Survey YPAS questionnaire obtaining weekly METs as a result
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 352020 | REGISTRY | Ejercicio multicomponente para mejorar el desempeño físico | None |