CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
Experimental:Motorized cycle ergometerother
Likely dose
Not stated in record
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Search/NCT04842396
NCT04842396N/ACompleted

Low-volume Cycling Training Improves Body Composition and Functionality in Older People With Multimorbidity

Universidade da Coruña·interventional·Posted Apr 13, 2021·Updated Oct 4, 2021

In Brief

A clinical study evaluating Experimental:Motorized cycle ergometer for Frailty and Morbidity, Multiple. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedApr 13, 2021
Enrollment StartSep 1, 2019
Primary CompletionDec 10, 2019
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 5.2 years ago

Interventions

Experimental:Motorized cycle ergometerother

Cycling training on the MOTOmed Muvi for 20 minutes 3 days per week for 6 weeks. Moreover, control of adverse events throughout the trial was measured through the assessment and monitoring of vital signs before, during (within the first 10 minutes), and after the intervention sessions. Vital signs \[heart rate (per minute), systolic and diastolic blood pressure (in millimeters of mercury, mm Hg), and oxygen saturation (in percentage)\] were monitored by a nurse and a medical doctor using mobile finger pulse oximeters.