Low-volume Cycling Training in Older People With Multimorbidity

NCT04842396 | Completed

• 6 other identifiers: 2018/010ED431C 2017/49ED431F 2017/09IN607C 2016/08IN607C 2017/02RYC-2015-18394
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty; Morbidity, Multiple

Keywords

physical exercise; body composition; physical functionality; blood pressure; individualized training; morbidity

Outcome Measures

Primary Outcomes (13)

• Body weight

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

  6 weeks

• Muscle mass

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

  6 weeks

• Fat mass

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

  6 week

• Fat mass percentage

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

  6 week

• 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

• 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

• 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

• 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

• Mean blood pressure

  Mean blood pressure (MBPrest, in mm Hg) is calculated as follows: MBP=DBP+1/3 (SBP-DBP)

  6 weeks

• 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

• 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: 1. three balance tasks (i.e., SPPB-B): side-by-side stand, semi-tandem stand, and tandem stand 2. gait speed test; walk 4 meters at a comfortable speed (i.e., SPPB-G) 3. 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

• 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

• 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

Study Arms (2)

Experimental: Motorized cycle ergometer

EXPERIMENTAL

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).

Other: Experimental:Motorized cycle ergometer

Control group

NO INTERVENTION

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.

Interventions

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.

Experimental: Motorized cycle ergometer

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade da Coruña: lead

Study Sites (1)

Universidade da Coruña

A Coruña, E-15071, Spain

Location

Related Publications (12)

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  PMID: 23798298 BACKGROUND

• 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.

  PMID: 30526319 BACKGROUND

• 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.

  PMID: 23997192 BACKGROUND

• 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.

  PMID: 32020713 BACKGROUND

• 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.

  PMID: 7114305 BACKGROUND

• 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.

  PMID: 3944402 BACKGROUND

• 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.

  PMID: 8126356 BACKGROUND

• 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.

  PMID: 21727302 BACKGROUND

• 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.

  PMID: 3558716 BACKGROUND

• 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.

  PMID: 23104970 BACKGROUND

• 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.

  PMID: 34183717 DERIVED

Related Links

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

MeSH Terms

Conditions

Frailty; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• José C. Millán-Calenti, PhD

  Universidade da Coruña

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 13, 2021
• Study Start: September 1, 2019
• Primary Completion: December 10, 2019
• Study Completion: December 10, 2019
• Last Updated: October 4, 2021

Record last verified: 2021-09

Locations

ES (1)