Clinical trial NCT01691131: Effects of Two Training Protocols in Patients With Chronic Obstructive Pulmonary Disease
Official title: Effects of Two Training Protocols in Physical Activity in Daily Life and Balance in Patients With COPD: Land Versus Water
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: Physical activity in daily life
Balance
COPD
Exercise training
Lead sponsor: Universidade Norte do Paraná
Sponsor class: OTHER
First posted: 2012-09-24
Enrollment: 36
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Therefore, we aim to 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Physical activity in daily life (measuremet unit: number of steps per day)
timeFrame: four years
Secondary outcomes:
measure: Static Balance (Center of Pressure Area in cm2)
timeFrame: four years
measure: Dynamic Balance (Timed up and go test in seconds)
timeFrame: four years
measure: Exercise capacity (6MWT: distance covered in meters; ISWT: distance covered in meters)
timeFrame: four years
measure: Quality of life (CRDQ: score in points)
timeFrame: four years
measure: Functional status (LCADL: score in points)
timeFrame: four years
Other outcomes:
Locations:
city: Londrina
country: Brazil
facility: Universidade Norte do Paraná
state: Paraná
Study officials:
affiliation: Universidade Estadual de Londrina
name: Fabio Pitta, PhD
role: STUDY_DIRECTOR
affiliation: Universidade Norte do Paraná
name: Vanessa S. Probst, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.