NCT05972239

Brief Summary

The aim of the study will be to verify whether the addition of an exercise program aimed to improve balance can reduce the risk of falling in subjects with COPD over 80 years of age compared to the standard rehabilitation program. Patients will be randomly assigned in two groups (intervention and control). The pulmonary rehabilitation (PR) program is organized in accordance with current guidelines.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

May 1, 2023

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 2, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2026

Completed
Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

May 23, 2023

Last Update Submit

April 14, 2026

Conditions

COPD

Keywords

ExerciseRehabilitationAgedpostural balance

Outcome Measures

Primary Outcomes (1)

  • Balance

    Berg Balance Scale (BBS). Scores range from 0 (worst) - 4 (best).

    3 weeks

Secondary Outcomes (9)

  • Peripheral muscle strenght

    3 weeks

  • Gait speed

    3 weeks

  • Health status

    3 weeks

  • Dyspnea

    3 weeks

  • Dyspnea on daily life activities

    3 weeks

  • +4 more secondary outcomes

Study Arms (2)

Control

ACTIVE COMPARATOR

Educational interventions, aerobic and strenght training, flexibility exercises.

Other: Standard pulmonary rehabilitation program

Intervention

EXPERIMENTAL

Educational interventions, aerobic and strenght training, balance training.

Other: Balance training added on standard pulmonary rehabilitation

Interventions

Standard pulmonary rehabilitation programOTHER

Educational interventions, 3 individual sessions of 10-20 minutes and 1 weekly group meeting of 45-60 minutes on nutrition and on the emotional management of the disease. Supervised and incremental aerobic training, lasting at least 30 minutes, 5/6 days a week for a total of 12-14 sessions. The initial workload will be set between 50-70% of the maximum load (watts) determined starting from the 6MWT using the Hill equation and will be increased to reach a perception of moderate-intense fatigue and/or dyspnea. Supervised strength training of the lower limbs and upper limbs, lasting 30 minutes, 5/6 times a week for a total of 12-14 sessions. The workload will be calibrated to allow the execution of 12 consecutive repetitions and will be progressively increased by 0.5 kg in order to cause a moderate/intense fatigue and/or dyspnea. Group exercises aimed at improving flexibility of the trunk, lower and upper limbs, lasting at least 30 minutes, 5/6 days a week, for a total of 12-14 sessions.

Control
Balance training added on standard pulmonary rehabilitationOTHER

Educational interventions, 3 individual sessions of 10-20 minutes and 1 weekly group meeting of 45-60 minutes on nutrition and on the emotional management of the disease. Supervised and incremental aerobic training, lasting at least 30 minutes, 5/6 days a week for a total of 12-14 sessions. The initial workload will be set between 50-70% of the maximum load determined from the 6MWT (Hill equation) and will be increased based on dyspnea. Supervised strength training of the lower limbs and upper limbs, lasting 30 minutes, 5/6 times a week for a total of 12-14 sessions. The workload will be progressively increased. Supervised balance training sessions lasting 30 minutes, 5/6 times a week for a total of 12-14 sessions. The sequence of the exercises will be personalized according to the result of the Berg Balance Scale and modified according to the progress.

Intervention

Eligibility Criteria

Age80 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age ≥ 80 years old,
  • Diagnosis of COPD according to GOLD Guidelines (Tiffenau Index \<70%) under optimized medical treatment,
  • Able to perform and complete study procedures.

You may not qualify if:

  • Anticholinergic Cognitive Burden score ≥3,
  • Mini-Mental State Examination \<22,
  • Acute or chronic impairment and/or medical diseases that are likely to preclude exercise testing and PR.
  • Brain lesions,
  • Inner ear disease
  • Visual deficit,
  • Lower limb surgery in the previous 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of pulmonary rehabilitation

Tradate, Varese, 21049, Italy

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor Activity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2023

First Posted

August 2, 2023

Study Start

May 1, 2023

Primary Completion

January 15, 2025

Study Completion

January 19, 2026

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)