Effects of Two Training Protocols in Patients With Chronic Obstructive Pulmonary Disease

NCT01691131 | Completed

• 1 other identifier: Unopar
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: There is evidence that demonstrate the beneficial effects of pulmonary rehabilitation programs (PR) on symptoms, exercise capacity, muscle strength and quality of life in patients with Chronic obstructive pulmonary disease (COPD). The majority of the studies used high intensity endurance and strength exercise training on land. Exercise on water is an effective form of training that has been used for decades for rehabilitation in different chronic conditions. In addition, there are promising preliminary results on the literature regarding aquatic training in patients with COPD. However, several gaps remain. Aim: Compare the effects of two rehabilitation programs with 6 months of duration in patients with COPD on physical activity in daily life and balance: land versus water. Methods: The sample will consist of 36 patients with COPD diagnosed according to the GOLD criteria, 50 years old or more and clinically stable. Patients will be evaluated in 3 different moments: before the PR, after the PR and 6 months after the end of the PR (follow up). In addition to the assessment of physical activity in daily life and balance, the investigators will also evaluate pulmonary function, peripheral and respiratory muscle strength, body composition, maximal and submaximal exercise capacity, functional status and quality of life. Both groups (land or water) will be submitted for 3 sessions of exercise training per week, with 45 minutes of duration, during 6 months. The sessions of both groups include the same exercises sequence. Endurance exercise training will be performed on a bicycle and walking on land and strength training using free weights. Workload will be established according to the tests performance on assessment and progression will follow a predetermined schedule and adjusted according symptoms. On water the same approach will be followed. Expected results: the investigators expect improvement in terms of symptoms, exercise capacity, muscle strength, quality of life, functional status and physical activity in daily life at the end of the two training protocols. However, it is unclear whether one training protocol will be superior than the other. Due to the characteristics involved in the aquatic training, the investigators hypothesized that this type of training can result in better results on balance.

Conditions

COPD

Keywords

Physical activity in daily life; Balance; COPD; Exercise training

Outcome Measures

Primary Outcomes (1)

• Physical activity in daily life (measuremet unit: number of steps per day)

  The objectively assessed level of physical activity in daily life will be monitored using the activity monitor Power Walker PW 610 (Yamax, Japan). This device is validated in patients with COPD and the main variables are the number of steps per day and estimation of daily energy expenditure. The monitor will be individually set taking into consideration body weight and step length (measured in a 10-meter walking at usual speed). Patients will wear the device 12 hours per day during 6 days, and the average of these six days will be used for analysis.

  four years

Secondary Outcomes (5)

• Static Balance (Center of Pressure Area in cm2)

  four years

• Dynamic Balance (Timed up and go test in seconds)

  four years

• Exercise capacity (6MWT: distance covered in meters; ISWT: distance covered in meters)

  four years

• Quality of life (CRDQ: score in points)

  four years

• Functional status (LCADL: score in points)

  four years

Study Arms (2)

Exercise training on land

OTHER

High intensity exercise training on land.

Other: Exercise training

Exercise training on water

OTHER

High intensity exercise training on water.

Other: Exercise training

Interventions

Exercise training OTHER

Comparison of high intensity exercise training on land versus water.

Also known as: Exercise training on land;, Exercise training on water.

Exercise training on land; Exercise training on water

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD diagnosis (according to the GOLD criteria);
• Stable condition, no exacerbations or infections in the last 3 months;
• No severe or unstable heart disease;
• No other pathological conditions that could influence the training performance;
• Not have participated in other rehabilitation programs in the last six months.

You may not qualify if:

• Occurrence of acute exacerbation during the evaluation period;
• Not understanding or non-cooperation regarding the procedures and research methods;
• Option of the participant to leave the study for any reason;
• Presence of vestibular disorders (BPPV, labyrinthitis, among others).

Sponsors & Collaborators

• Universidade Norte do Paraná: lead

Study Sites (1)

Universidade Norte do Paraná

Londrina, Paraná, 86041-120, Brazil

Location

Related Publications (2)

• de Castro LA, Felcar JM, de Carvalho DR, Vidotto LS, da Silva RA, Pitta F, Probst VS. Effects of land- and water-based exercise programmes on postural balance in individuals with COPD: additional results from a randomised clinical trial. Physiotherapy. 2020 Jun;107:58-65. doi: 10.1016/j.physio.2019.08.001. Epub 2019 Aug 6.

  PMID: 32026836 DERIVED

• Felcar JM, Probst VS, de Carvalho DR, Merli MF, Mesquita R, Vidotto LS, Ribeiro LRG, Pitta F. Effects of exercise training in water and on land in patients with COPD: a randomised clinical trial. Physiotherapy. 2018 Dec;104(4):408-416. doi: 10.1016/j.physio.2017.10.009. Epub 2018 Mar 1.

  PMID: 30477678 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Fabio Pitta, PhD

  Universidade Estadual de Londrina

  STUDY DIRECTOR

• Vanessa S. Probst, PhD

  Universidade Norte do Paraná

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2012
• First Posted: September 24, 2012
• Study Start: July 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 6, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)