NCT07605117

Brief Summary

Isoinertial training is emerging as a potentially effective strategy to improve strength and functionality in older people diagnosed with chronic obstructive pulmonary disease (COPD), due to its influence on muscle mass and neuromuscular efficiency. COPD is characterized by systemic alterations, including peripheral muscle dysfunction; which contributes to patient functional limitation, and reduces patients' quality of life. Isoinertial training may improve the physiological response to effort, and also promote functional performance in this population. Hence, the aim of this study is to evaluate the effect of an isoinertial training program on muscle strength and functional capacity in patients with COPD during an 8-week intervention.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress20%
May 2026Jul 2026

First Submitted

Initial submission to the registry

May 5, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

May 7, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2026

Expected
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2026

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

May 5, 2026

Last Update Submit

May 19, 2026

Conditions

Keywords

Muscle StrengthFunctional CapacityPulmonary RehabilitationInterventional studyAdultsExerciseFlywheel trainingLung Disease

Outcome Measures

Primary Outcomes (5)

  • Change in upper limb muscle strength using the Hand Grip Test (HGT)

    Manual grip strength will be evaluated by dynamometry, as an indicator of peripheral muscle strength in patients with COPD.

    Baseline and 8-week follow-up

  • Change in functional capacity by 6-minute walk test (6MWT)

    The distance covered for 6 minutes will be evaluated as an indicator of exercise tolerance and functional capacity.

    Baseline and 8-week follow-up

  • Lower limb functional performance

    The number of repetitions performed in 30 seconds will be recorded as an indicator of functional strength-endurance in the lower limbs

    Baseline and 8-week follow-up

  • Change in functional mobility using the Timed Up and Go Test (TUG)

    The time needed to get up from a chair, walk, turn and sit down again will be measured, as an indicator of mobility and functional risk.

    Baseline and 8-week follow-up

  • Change in muscle quality index (MQI)

    Muscle quality will be estimated using the MQI, which evaluates the muscle power of the lower limbs considering leg length, body mass, gravitational acceleration and time required to complete 10 sit-to-stand repetitions

    Baseline and 8-week follow-up

Secondary Outcomes (6)

  • Change in functional performance using 5 Times Sit-to-Stand Test (5STS)

    Baseline and 8-week follow-up

  • Change in health-related quality of life through The Saint George's Respiratory Questionnaire (SGRQ)

    Baseline and 8-week follow-up

  • Changes in Body Mass Index (BMI)

    Baseline and 8-week follow-up

  • Changes in heart rate

    Baseline and 8-week follow-up

  • Changes in blood pressure

    Baseline and 8-week follow-up

  • +1 more secondary outcomes

Study Arms (2)

Supervised isoinertial training

EXPERIMENTAL

Participants will perform a supervised isoinertial training program during 8 weeks of follow-up

Device: Isoinertial training

Traditional rehabilitation

ACTIVE COMPARATOR

Participants involved in the usual pulmonary rehabilitation program * The usual recommendations for physical activity and clinical follow-up will be maintained * No isoinertial training

Other: Traditional rehabilitation (control group)

Interventions

Supervised isoinertial training: * Participants will perform a supervised isoinertial training program during 8 weeks of follow-up * The intervention will have a frequency of 2 to 3 weekly sessions * The program will include exercises aimed at strengthening the upper and lower limbs using a isoinertial device * The training load will be progressive to each participant and adjusted according to the individual response. * The program will be carried out in combination with usual pulmonary rehabilitation care.

Supervised isoinertial training

Traditional treatment (control group) * Participants involved in the usual pulmonary rehabilitation program during 8 weeks with a frequency of 2-3 sessions per week. * This program includes low- to moderate-intensity aerobic exercise, joint mobility activities and general strengthening exercises using conventional resources according to the clinic's rehabilitation protocol. * No isoinertial training

Traditional rehabilitation

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • People between 50 - 80 years of age diagnosed with moderate or severe COPD
  • No acute exacerbations in the last 4 weeks
  • Sufficient functional capacity to exercise
  • Signed informed consent

You may not qualify if:

  • Presence of neurological, musculoskeletal, or cardiovascular diseases that significantly limit exercise performance or compromise participant safety; including uncontrolled hypertension, recent myocardial infarction, unstable angina, severe osteoarthritis, stroke sequelae, or Parkinson's disease.
  • Contraindications to exercise participation according to medical evaluation.
  • Recent surgeries in the past 3 months
  • Simultaneous participation in other exercise programs
  • Cognitive disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universidad Manuela Beltrán

Bogotá, Bogotá, DC, 110231, Colombia

Location

Pulsar Unidad de Neumologia y Rehabilitación Pulmonar

Ibague, Ibagué, 730006, Colombia

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor ActivityLung Diseases

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

David Murcia-Lesmes, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 5, 2026

First Posted

May 22, 2026

Study Start

May 7, 2026

Primary Completion (Estimated)

July 25, 2026

Study Completion (Estimated)

July 27, 2026

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Data availability to external researchers is restricted to related project proposals upon request to the PI.

Locations