Low-volume Cycling Training in Older People With Multimorbidity

Study Results

Results pending

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2019-12-10

Brief Summary

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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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Detailed Description

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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.

Conditions

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Frailty Morbidity, Multiple

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental: Motorized cycle ergometer

The exercise group cycles 20 minutes per session on the MOTOmed Muvi 3 days per week for 6 weeks at an intensity guided by the perception of effort.

A cycling cadence is fixed between 25 and 30 rpm for all sessions since that cadence is comfortable for every participant. Researchers adjust resistance on the motorized cycle to increase the external load until it reached the level required to reach the intensity of effort programmed by the OMNI-RPE. The six weeks are programmed in the form of two intensity-differentiated training phases of three weeks. In the first training phase (i.e., the first three weeks), participants are requested to cycle simultaneously with the upper and lower limbs at an intensity equivalent to a perception of 3 (i.e., easy to somewhat moderate) on the OMNI-RPE (0-10).

Group Type EXPERIMENTAL

Experimental:Motorized cycle ergometer

Intervention Type 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.

Control group

Participants are evaluated the week before and the week after the experimental group finishes the training period (pre- vs. postintervention) to facilitate an examination of the changes in body composition, functional performance, and resting cardiovascular state.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Experimental:Motorized cycle ergometer

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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José Carlos Millán Calenti

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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José C. Millán-Calenti, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade da Coruña

Locations

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Universidade da Coruña

A Coruña, , Spain

Site Status

Countries

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Spain

References

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Reference Type BACKGROUND

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Booth FW, Roberts CK, Laye MJ. Lack of exercise is a major cause of chronic diseases. Compr Physiol. 2012 Apr;2(2):1143-211. doi: 10.1002/cphy.c110025.

Reference Type BACKGROUND

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Pedersen BK. The Physiology of Optimizing Health with a Focus on Exercise as Medicine. Annu Rev Physiol. 2019 Feb 10;81:607-627. doi: 10.1146/annurev-physiol-020518-114339. Epub 2018 Dec 10.

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Reference Type BACKGROUND

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Cunningham C, O' Sullivan R, Caserotti P, Tully MA. Consequences of physical inactivity in older adults: A systematic review of reviews and meta-analyses. Scand J Med Sci Sports. 2020 May;30(5):816-827. doi: 10.1111/sms.13616. Epub 2020 Feb 4.

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Reisberg B, Ferris SH, de Leon MJ, Crook T. The Global Deterioration Scale for assessment of primary degenerative dementia. Am J Psychiatry. 1982 Sep;139(9):1136-9. doi: 10.1176/ajp.139.9.1136.

Reference Type BACKGROUND

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Tinetti ME. Performance-oriented assessment of mobility problems in elderly patients. J Am Geriatr Soc. 1986 Feb;34(2):119-26. doi: 10.1111/j.1532-5415.1986.tb05480.x. No abstract available.

Reference Type BACKGROUND

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Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.

Reference Type BACKGROUND

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Guidetti L, Sgadari A, Buzzachera CF, Broccatelli M, Utter AC, Goss FL, Baldari C. Validation of the OMNI-cycle scale of perceived exertion in the elderly. J Aging Phys Act. 2011 Jul;19(3):214-24. doi: 10.1123/japa.19.3.214.

Reference Type BACKGROUND

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Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.

Reference Type BACKGROUND

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Mezzani A, Hamm LF, Jones AM, McBride PE, Moholdt T, Stone JA, Urhausen A, Williams MA; European Association for Cardiovascular Prevention and Rehabilitation; American Association of Cardiovascular and Pulmonary Rehabilitation; Canadian Association of Cardiac Rehabilitation. Aerobic exercise intensity assessment and prescription in cardiac rehabilitation: a joint position statement of the European Association for Cardiovascular Prevention and Rehabilitation, the American Association of Cardiovascular and Pulmonary Rehabilitation and the Canadian Association of Cardiac Rehabilitation. Eur J Prev Cardiol. 2013 Jun;20(3):442-67. doi: 10.1177/2047487312460484. Epub 2012 Oct 26.

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Carballeira E, Censi KC, Maseda A, Lopez-Lopez R, Lorenzo-Lopez L, Millan-Calenti JC. Low-volume cycling training improves body composition and functionality in older people with multimorbidity: a randomized controlled trial. Sci Rep. 2021 Jun 28;11(1):13364. doi: 10.1038/s41598-021-92716-9.

Reference Type DERIVED

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Provided Documents

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Document Type: Statistical Analysis Plan

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