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Low-volume Cycling Training in Older People With Multimorbidity

Primary Purpose

Frailty, Morbidity, Multiple

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Experimental:Motorized cycle ergometer
Sponsored by
Universidade da Coruña
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frailty focused on measuring physical exercise, body composition, physical functionality, blood pressure, individualized training, morbidity

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidade da Coruña

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental: Motorized cycle ergometer

Control group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Body weight
Body composition evaluation by Bioimpedance analysis (Inbody 270): body weight (in kg)
Muscle mass
Body composition evaluation by bioimpedance analysis (Inbody 270): muscle mass (MM, in kg)
Fat mass
Body composition evaluation by bioimpedance analysis (Inbody 270): fat mass (FM, in kg).
Fat mass percentage
Body composition evaluation by bioimpedance analysis (Inbody 270): fat mass percentage.
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.
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.
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.
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.
Mean blood pressure
Mean blood pressure (MBPrest, in mm Hg) is calculated as follows: MBP=DBP+1/3 (SBP-DBP)
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.
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.
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.
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).

Secondary Outcome Measures

Full Information

First Posted
April 6, 2021
Last Updated
September 27, 2021
Sponsor
Universidade da Coruña
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1. Study Identification

Unique Protocol Identification Number
NCT04842396
Brief Title
Low-volume Cycling Training in Older People With Multimorbidity
Official Title
Low-volume Cycling Training Improves Body Composition and Functionality in Older People With Multimorbidity
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
December 10, 2019 (Actual)
Study Completion Date
December 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade da Coruña

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Morbidity, Multiple
Keywords
physical exercise, body composition, physical functionality, blood pressure, individualized training, morbidity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Motorized cycle ergometer
Arm Type
Experimental
Arm Description
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).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Experimental:Motorized cycle ergometer
Intervention Description
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 Outcome Measure Information:
Title
Body weight
Description
Body composition evaluation by Bioimpedance analysis (Inbody 270): body weight (in kg)
Time Frame
6 weeks
Title
Muscle mass
Description
Body composition evaluation by bioimpedance analysis (Inbody 270): muscle mass (MM, in kg)
Time Frame
6 weeks
Title
Fat mass
Description
Body composition evaluation by bioimpedance analysis (Inbody 270): fat mass (FM, in kg).
Time Frame
6 week
Title
Fat mass percentage
Description
Body composition evaluation by bioimpedance analysis (Inbody 270): fat mass percentage.
Time Frame
6 week
Title
Waist circumference
Description
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.
Time Frame
6 weeks
Title
Heart rate
Description
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.
Time Frame
6 weeks
Title
Systolic blood pressure
Description
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.
Time Frame
6 weeks
Title
Diastolic blood pressure
Description
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.
Time Frame
6 weeks
Title
Mean blood pressure
Description
Mean blood pressure (MBPrest, in mm Hg) is calculated as follows: MBP=DBP+1/3 (SBP-DBP)
Time Frame
6 weeks
Title
The Performance-Oriented Mobility Assessment (POMA)
Description
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.
Time Frame
6 weeks
Title
The Short Physical Performance Battery test (SPPB)
Description
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.
Time Frame
6 weeks
Title
Chair Sit-and-Reach Test (CSR)
Description
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.
Time Frame
6 weeks
Title
Frailty
Description
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).
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José C. Millán-Calenti, PhD
Organizational Affiliation
Universidade da Coruña
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade da Coruña
City
A Coruña
ZIP/Postal Code
E-15071
Country
Spain

12. IPD Sharing Statement

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27500661
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Links:
URL
https://apps.who.int/iris/bitstream/handle/10665/272722/9789241514187-eng.pdf?ua=1
Description
9. World Health Organization. Global action plan on physical activity 2018-2030: more active people for a healthier world
URL
https://apps.who.int/iris/bitstream/handle/10665/44399/9789241599979_eng.pdf?sequence=1.
Description
10. World Health Organization. Global recommendations on physical activity for health

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Low-volume Cycling Training in Older People With Multimorbidity

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