Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05895760 |
| Other study ID # |
SALUD-2021-PHYSICAL EXERCISE |
| Secondary ID |
35/2020 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2021 |
| Est. completion date |
October 31, 2021 |
Study information
| Verified date |
May 2023 |
| Source |
Universidad Iberoamericana A.C., Mexico |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 (68.45±5.54 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.
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 No35/2020. 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 ≤ 60/100 score)
- Adults with cognitive impairment (defined as a mini-mental state examination (MMSE)
score <24/30)
- 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 (fractures/falls) 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 ≥1.0 point with a SD of 0.99 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 1:1
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 (i.e. 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 participant's 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 activities.This information is available on the You Tube platform.
https://www.youtube.com/@nutriciongeriatrica/videos
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 years).Health 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.
