Effects of Resistance Training in Centenarians

NCT07118423 | Completed

• 1 other identifier: #PI18/381
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multicenter intervention evaluating the effectiveness and safety of resistance training in institutionalized centenarians. The aim of the study is to analyze the effects of 12 weeks of resistance training on frailty, muscle power, physical function, strength, functional independence, physical activity, cardiovascular health, cognitive function, and quality of life in adults aged 100 and over living in nursing homes.

Conditions

Frailty; Muscle Power; Old and Very Old People; Cognitive Abilities; Physical Activity

Outcome Measures

Primary Outcomes (24)

• Frailty using Fried's Frailty Criteria

  Fried's frailty phenotype is based on five criteria (habitual gait speed, handgrip strength , involuntary weight loss, exhaustion and low physical activity). The score ranges from 0 to 5, where each criterion met counts as one point. A score of 0 indicates best status, while a score of 5 indicates worst status.

  T0 (baseline) and T1 (post 12 weeks)

• Frailty using Frailty Trait Scale - Short Form

  Frailty Trait Scale - Short Form evaluates 5 domains, including body mass index, physical activity, static balance, habitual gait speed and handgrip strength. The score ranges from 0 to 50, where each criterion met counts as one point. A score of 0 indicates best status, while a score of 50 indicates worst status.

  T0 (baseline) and T1 (post 12 weeks)

• Muscle power

  Muscle power assessed in 30-s sit-to-stand test.

  T0 (baseline) and T1 (post 12 weeks)

• Physical function based on the Short Physical Performance Battery

  The Short Physical Performance Battery is based on the ability to stand with the feet together in the side-by-side, semi-tandem, and tandem positions, time to walk 4 meters, and time to rise from a chair and return to the seated position 5 times. The score ranges from 0 to 12 points. Higher scores indicate better physical function, while lower scores reflect poorer physical function.

  T0 (baseline) and T1 (post 12 weeks)

• Physical function using Physical Performance Mobility Examination.

  The Physical Performance Mobility Examination includes six mobility tasks integral to daily life: bed mobility, transfer skills, multiple stands from chair, standing balance, step-up, and ambulation. The score ranges from 0 to 12 points. Higher scores indicate better physical function, while lower scores reflect poorer physical function.

  T0 (baseline) and T1 (post 12 weeks)

• Physical function based on the gait speed in 6 meters.

  Gait speed is measured in meters per second (m/s). Higher values indicate better mobility.

  T0 (baseline) and T1 (post 12 weeks)

• Physical function using the Time Up and Go test.

  The Timed Up and Go test measures the time it takes participants to stand up, walk 3 meters, turn around, and sit back down. Shorter times reflect better mobility

  T0 (baseline) and T1 (post 12 weeks)

• Cognitive function using Mini Mental State Examination.

  Mini Mental State Examination questionnaire incorporates 11 items that measure attention and orientation, memory, registration, recall, calculation, language, and ability to draw a complex polygon, and results in scores ranging from 1 (lowest cognitive function) to 30 (highest cognitive function) points.

  T0 (baseline) and T1 (post 12 weeks)

• Cognitive function using the animal naming test within 1 minute.

  In the animal naming test, participants are asked to name as many animals as possible in 60 seconds. The higher number of correctly named reflects better cognitive function.

  T0 (baseline) and T1 (post 12 weeks)

• Cognitive function using the clock drawing test.

  The score in the clock drawing test ranges from 0 to 10. This score evalutes visuospatial skills, executive functions, and the ability to follow instructions. Higher scores indicate better cognitive function.

  T0 (baseline) and T1 (post 12 weeks)

• Quality of life using EuroQoL-5 Dimension questionnaire.

  EuroQoL-5D Index ranges from a value of 1 (best state of health) to 0 (death). Although there are negative values for the index, corresponding to those states of health that are valued as worse than death.

  T0 (baseline) and T1 (post 12 weeks)

• Quality of life using Visual Analog Scale.

  Visual Analog Scale evaluates self-reported quality of life on a vertical scale ranging from 0 (worst health) to 100 (best health). This score provides a subjective measure of the patient's perception of their current health status.

  T0 (baseline) and T1 (post 12 weeks)

• Isometric muscle strength

  Maximum voluntary isometric strength in handgrip, knee extension, elbow flexion and should abduction, measured using a dynamometer.

  T0 (baseline) and T1 (post 12 weeks)

• Disability

  The Barthel index is a 10-item questionnaire that provides information about the autonomy to cook food, wash, dress, groom, perform bowel movements and urination, go to the toilet, move from the bed to the chair, walk and climb stair. The total score ranges from 0 to 100, with higher scores indicating greater independence (best), and lower scores indicating higher levels of dependence in basic daily activities.

  T0 (baseline) and T1 (post 12 weeks)

• Accelerometer-based physical activity

  Measurement of physical activity levels (i.e., time spent in light-intensity and moderate-to-vigorous intensity) by accelerometer 24 hours a day for seven consecutive days using a GENEActiv device worn on the non-dominant wrist.

  T0 (baseline) and T1 (post 12 weeks)

• Falls

  The number of falls in the last year was registered.

  T0 (baseline) and T1 (post 12 weeks)

• Heart rate variability indices from electrocardiogram (ECG)

  Heart rate variability indices were derived from 10-minute resting recordings using a 12-lead Holter ECG. Both linear indices (time and frequency domains) and non-linear indices (detrended fluctuation ) were calculated from the ECG recording.

  T0 (baseline) and T1 (post 12 weeks)

• Blood pressure

  Blood pressure is measured in millimeters of mercury (mmHg), including systolic, diastolic, and mean arterial pressure (calculated as diastolic pressure plus one-third of the difference between systolic and diastolic pressures).

  T0 (baseline) and T1 (post 12 weeks)

• Ankle-brachial index relate to blood pressure

  The ankle-brachial index (ABI) is calculated by measuring systolic pressure in both ankles and both arms. The highest systolic pressure from the arms is used as a reference. The highest systolic pressure from each ankle is divided by this reference to obtain an ABI for each leg. The final ABI value is the lower of the two leg measurements.

  T0 (baseline) and T1 (post 12 weeks)

• Albumin

  Albumin concentration is measured in blood samples.

  T0 (baseline) and T1 (post 12 weeks)

• C-reactive protein

  C-reactive protein concentration is measured in blood samples.

  T0 (baseline) and T1 (post 12 weeks)

• inflammatory cytokines

  Inflammatory cytokines (IL-6 and IL-1β) are measured in blood samples.

  T0 (baseline) and T1 (post 12 weeks)

• Circulating microRNA levels

  MicroRNAs associated with frailty (miR-194-5p, miR-125b-5p) are measured in blood samples.

  T0 (baseline) and T1 (post 12 weeks)

• Gene expressions of aging (ABLIM1, CCR7, LEF1, EGR1)

  Gene expressions of aging (ABLIM1, CCR7, LEF1, EGR1) are measured in blood samples.

  T0 (baseline) and T1 (post 12 weeks)

Secondary Outcomes (1)

• Resilience

  Only baseline (T0)

Study Arms (2)

Exercise group

EXPERIMENTAL

The exercise group performed twice per week, nonconsecutive, resistance training over 12 weeks. Exercise sessions consisted of 1-3 sets of the 8-exercise routine at 50-70% of the estimated one-repetition maximum.

Other: Exercise

Control group

NO INTERVENTION

The control group received the usual care in nursing homes.

Interventions

Exercise OTHER

The intervention group performed twice per week, nonconsecutive, resistance training over 12 weeks. The sessions consisted of 1-3 sets of eight exercises at 50-70% of the estimated one-repetition maximum.

Exercise group

Eligibility Criteria

• Age: 100 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Women and men aged 100 years and over living in geriatric nursing homes.

You may not qualify if:

• Participants were excluded if they were bedridden, going through an acute disease or presented any clinical condition contraindicating physical exercise as outlined in the American College of Sports Medicine's Guidelines.

Sponsors & Collaborators

• Universidad de Zaragoza: lead
• University of Castilla-La Mancha: collaborator

Study Sites (1)

University of Zaragoza

Zaragoza, Zaragoza, Spain

Location

MeSH Terms

Conditions

Frailty; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nuria Garatachea, PhD

  Universidad de Zaragoza

  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: PhD

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: August 12, 2025
• Study Start: January 8, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: August 12, 2025

Record last verified: 2025-08

Locations

ES (1)