Clinical trial NCT04842396: Low-volume Cycling Training in Older People With Multimorbidity
Official title: Low-volume Cycling Training Improves Body Composition and Functionality in Older People With Multimorbidity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Morbidity, Multiple
Keywords: physical exercise
body composition
physical functionality
blood pressure
individualized training
morbidity
Lead sponsor: Universidade da Coruña
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 24
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: INTRODUCTION: Physical exercise, when practiced regularly and in adequate doses, is a proven nonpharmacological measure that helps to prevent and reverse noncommunicable diseases, as well as reduce mortality rates from any cause. In general, older adults perform insufficient physical activity and do not meet the doses recommended by the World Health Organization for the improvement of health through physical activity.

OBJECTIVE: Our main aim will be to evaluate the effect of a 6-week intervention on health-related outcomes (body composition, hemodynamic and functionality changes) in 24 individuals aged 65 and older with multimorbidity.

METHODS AND ANALYSIS: The study was a 2 x 2 randomized controlled trial using a two-group design (exercise vs. control) and two repeated measures (pre- vs. postintervention). The intervention (on the MOTOmed Muvi) will consist of a very low volume (60 minutes per week) of low-to-moderate intensity exercise training to assess body composition evaluation, hemodynamic parameter evaluation and functional evaluation. Participants will be recruited at the Gerontological Complex La Milagrosa (A Coruña, Spain), consisting of a daycare center and a nursing home.

For the statistical analysis, nonparametric ANOVA type statistics and mixed models for repeated measures will be used.

Detailed description: INTRODUCTION. Aging is a risk factor for most chronic diseases, and the presence of more than two diseases (i.e., multimorbidity), which is frequent in almost two out of three older adults, has been related to an increased risk of disability and frailty, a decrease in quality of life, and mortality. Physical activity (PA) acts as a nonpharmacological intervention and regular physical activity (rPA) reduces rates of all-cause mortality, compresses morbidity, decreases healthcare costs, and has relatively minimal adverse effects compared to drugs. It has been estimated that 27.5% of the world's population in 2016 did not meet the recommendations established for the member states of the World Health Organization (WHO) for health-enhancing physical activity. Furthermore, recent studies showed that moderate-intensity physical activity may be sufficient for reducing the risk of all-cause dementia and that some of the protective benefits of physical activity for older adults. It seems indispensable to study adequate doses of exercise for older people who often have low levels of physical activity and fitness, who spend a large amount of time sitting down, and whose multimorbidity keeps them away from exercising.

OBJECTIVE: To study the effects of perception-regulated low-volume and low-to-moderate intensity training on body composition, hemodynamic parameters, and functional performance in older adults with multimorbidity.

MATERIAL AND METHODS: The study is a 2 x 2 randomized controlled trial using a two-group design (exercise vs. control) and two repeated measures (pre- vs. postintervention). The exercise group is requested to accomplish on the MOTOmed Muvi, a low volume (i.e., 20 minutes, 3 days per week) and low-to-moderate intensity combining upper and lower limb recumbent cycling training for six weeks. Participants are evaluated to examine the changes in body composition, functional performance, and resting cardiovascular state. Furthermore, participants are monitored physiologically during each session (HR and blood pressure) to control any possible adverse effects. Participants are recruited at the Gerontological Complex La Milagrosa (A Coruña, Spain), consisting of a daycare center and a nursing home. 24 participants will be recruited and randomly placed into two groups: the exercise group (EG, n=12) and the control group (CG, n=12). A stratified permuted block randomization is employed that accounted for the GDS score, sex, and type of institutionalization.

DATA ANALYSIS AND STATISTICS: Data will be presented as the median and interquartile range for ordinal variables and the estimated marginal mean ± standard deviation (SD) for continuous variables. The effect of the intervention will be analyzed employing nparLD (nonparametric analysis of longitudinal data in factorial experiments) from the R software package. Changes within and between groups will be analyzed by employing mixed models for repeated measures designs with the module GAMLj, which uses the R formulation of random effects as implemented by the lme4 R package in Jamovi software.

Eligibility criteria: Inclusion criteria:

* men and women aged 65 and older
* users of a care setting-daycare patients or nursing home residents
* a score \< 5 in the Global Deterioration Scale (GDS), from no cognitive decline to moderate cognitive decline.

Exclusion criteria:

* physical limitations or musculoskeletal injuries that could affect cycling training performance; physical exercise contraindicated by the physiotherapist and verified by the medical doctor according to the medical register of each participant
* heart failure with a functional class according to the New York Heart Association (NYHA) Classification of NYHA III and IV
* the presence of acute pain that does not allow exercise training
* recent acute myocardial infarction (in last 6 months) or unstable angina
* uncontrolled hypotension
* uncontrolled arterial hypertension (\>180/100 mmHg)
* active cancer treatment with chemotherapy
* patients with an active pacemaker and/or uncontrolled block
* diabetes mellitus with acute decompensation or uncontrolled hypoglycemia
* any other circumstance that precludes individuals from completing the training intervention.

Primary outcomes:
measure: Body weight
timeFrame: 6 weeks
measure: Muscle mass
timeFrame: 6 weeks
measure: Fat mass
timeFrame: 6 week
measure: Fat mass percentage
timeFrame: 6 week
measure: Waist circumference
timeFrame: 6 weeks
measure: Heart rate
timeFrame: 6 weeks
measure: Systolic blood pressure
timeFrame: 6 weeks
measure: Diastolic blood pressure
timeFrame: 6 weeks
measure: Mean blood pressure
timeFrame: 6 weeks
measure: The Performance-Oriented Mobility Assessment (POMA)
timeFrame: 6 weeks
measure: The Short Physical Performance Battery test (SPPB)
timeFrame: 6 weeks
measure: Chair Sit-and-Reach Test (CSR)
timeFrame: 6 weeks
measure: Frailty
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: A Coruña
country: Spain
facility: Universidade da Coruña
Study officials:
affiliation: Universidade da Coruña
name: José C. Millán-Calenti, PhD
role: PRINCIPAL_INVESTIGATOR
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