Low-volume Cycling Training in Older People With Multimorbidity

Frailty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04842396
• Other study ID #: 2018/010
• Secondary ID: ED431C 2017/49ED
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: December 10, 2019

Study information

• Verified date: September 2021
• Source: Universidade da Coruña
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 10, 2019
• Est. primary completion date: December 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Frailty
• Morbidity, Multiple

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Spain	Universidade da Coruña	A Coruña

Sponsors (1)

Lead Sponsor	Collaborator
Universidade da Coruña

Country where clinical trial is conducted

Spain, 

References & Publications (11)

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. Review. — View Citation

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. — View Citation

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. — View Citation

Fiuza-Luces C, Garatachea N, Berger NA, Lucia A. Exercise is the real polypill. Physiology (Bethesda). 2013 Sep;28(5):330-58. doi: 10.1152/physiol.00019.2013. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Nunes BP, Flores TR, Mielke GI, Thumé E, Facchini LA. Multimorbidity and mortality in older adults: A systematic review and meta-analysis. Arch Gerontol Geriatr. 2016 Nov-Dec;67:130-8. doi: 10.1016/j.archger.2016.07.008. Epub 2016 Aug 2. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Tinetti ME. Performance-oriented assessment of mobility problems in elderly patients. J Am Geriatr Soc. 1986 Feb;34(2):119-26. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight	Body composition evaluation by Bioimpedance analysis (Inbody 270): body weight (in kg)	6 weeks
Primary	Muscle mass	Body composition evaluation by bioimpedance analysis (Inbody 270): muscle mass (MM, in kg)	6 weeks
Primary	Fat mass	Body composition evaluation by bioimpedance analysis (Inbody 270): fat mass (FM, in kg).	6 week
Primary	Fat mass percentage	Body composition evaluation by bioimpedance analysis (Inbody 270): fat mass percentage.	6 week
Primary	Waist circumference	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 weeks
Primary	Heart rate	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.	6 weeks
Primary	Systolic blood pressure	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.	6 weeks
Primary	Diastolic blood pressure	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.	6 weeks
Primary	Mean blood pressure	Mean blood pressure (MBPrest, in mm Hg) is calculated as follows: MBP=DBP+1/3 (SBP-DBP)	6 weeks
Primary	The Performance-Oriented Mobility Assessment (POMA)	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.	6 weeks
Primary	The Short Physical Performance Battery test (SPPB)	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.	6 weeks
Primary	Chair Sit-and-Reach Test (CSR)	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.	6 weeks
Primary	Frailty	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).	6 weeks

External Links

•   10. World Health Organization. Global recommendations on physical activity for health
•   9. World Health Organization. Global action plan on physical activity 2018-2030: more active people for a healthier world