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NCT Number: NCT04842396

Low-volume Cycling Training in Older People With Multimorbidity

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.

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Key information

Conditions

Frailty Behavior Morbidity, Multiple Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade da Coruña

A Coruña, E-15071, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experimental:Motorized cycle ergometer

Other

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.

Primary outcomes

  1. Body weight

    Time frame: 6 weeks

    Body composition evaluation by Bioimpedance analysis (Inbody 270): body weight (in kg)

  2. Muscle mass

    Time frame: 6 weeks

    Body composition evaluation by bioimpedance analysis (Inbody 270): muscle mass (MM, in kg)

  3. Fat mass

    Time frame: 6 week

    Body composition evaluation by bioimpedance analysis (Inbody 270): fat mass (FM, in kg).

  4. Fat mass percentage

    Time frame: 6 week

    Body composition evaluation by bioimpedance analysis (Inbody 270): fat mass percentage.

  5. Waist circumference

    Time frame: 6 weeks

    Waist circumference (WC, cm) is taken at end tidal using a measuring tape to the nearest 0.1 cm, midway between the lowest rib and the iliac crest, which corresponded with the level of the umbilicus.

  6. Heart rate

    Time frame: 6 weeks

    The baseline hemodynamic state is characterized by storing the mean of the three lowest values for thirty seconds of heart rate (HRrest; in BPM, beats per minute) with a finger pulse oximeter.

  7. Systolic blood pressure

    Time frame: 6 weeks

    Blood pressure (mm Hg) by the auscultator method using a properly calibrated mercury column sphygmomanometer flexible cuff of the appropriate size and a stethoscope. Three systolic (SBPrest) measurements are recorded at 1-minute intervals.

  8. Diastolic blood pressure

    Time frame: 6 weeks

    Blood pressure (mm Hg) by the auscultator method using a properly calibrated mercury column sphygmomanometer flexible cuff of the appropriate size and a stethoscope.Three diastolic blood pressure (DBPrest) measurements are recorded at 1-minute intervals.

  9. Mean blood pressure

    Time frame: 6 weeks

    Mean blood pressure (MBPrest, in mm Hg) is calculated as follows:

    MBP=DBP+1/3 (SBP-DBP)

  10. The Performance-Oriented Mobility Assessment (POMA)

    Time frame: 6 weeks

    Functional evaluation: The Performance-Oriented Mobility Assessment (i.e., POMA), which measures balance (i.e., POMA-B; scored over 16) and gait performance (i.e., POMA-G; scored over 12) and the total score (i.e., POMA-T; scored over 28). A lower score implies a higher risk of falling. 25-28= low fall risk; 19-24= medium fall risk; and <19= high fall risk.

  11. The Short Physical Performance Battery test (SPPB)

    Time frame: 6 weeks

    Functional evaluation: The Short Physical Performance Battery test (i.e., SPPB) to evaluate the time spent to complete three components:

    • three balance tasks (i.e., SPPB-B): side-by-side stand, semi-tandem stand, and tandem stand
    • gait speed test; walk 4 meters at a comfortable speed (i.e., SPPB-G)
    • chair stand test; sit-to-stand 5 times from a chair (i.e., SPPB-ChS). Each component is scored out of 4, giving a maximum of 12 and a minimum of 0. A higher score implies better function and lower fall rate.

  12. Chair Sit-and-Reach Test (CSR)

    Time frame: 6 weeks

    Functional evaluation: Chair Sit-and-Reach Test (CSR) to measure lower body flexibility. The score (in cm) is the most distant point reached with the fingertips. Lower distances implies lower flexibility.

  13. Frailty

    Time frame: 6 weeks

    Functional evaluation: Frailty assessed by Fried et al. (2001) phenotype, consisting of five components: unintentional weight loss, self-reported exhaustion, weakness (grip strength), slow walking speed, and low physical activity. Individuals are classified as robust (zero positive components), pre-frail (one or two positive components) and frail (three or more positive components).

Sponsors and collaborators

Lead sponsor

Universidade da Coruña

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 13, 2021
Registry last updated
Oct 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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