Trial Outcomes & Findings for Effectiveness of Standardized Respiratory Physiotherapy in Primary Care (FREAP) (NCT NCT01152762)

Results Overview

The questionnaire is designed to measure the impact of respiratory symptoms and their treatment on a patient's daily life. It consists of various sections that cover a range of topics related to respiratory health, including symptoms, activity limitations, and overall well-being. The SGRQ questionnaire has 50 items with 76 weighted responses. Scores range from 0 to 100, with higher scores indicating more limitations.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

129 participants

Primary outcome timeframe

Six months

Results posted on

2026-08-06

Participant Flow

Participant milestones

Participant milestones
Measure	Control Group Normal primary care treatment	Standardized Respiratory Physiotherapy Standardized Respiratory Physiotherapy is the intervention in all selected patients
Overall Study STARTED	64	65
Overall Study COMPLETED	60	62
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness of Standardized Respiratory Physiotherapy in Primary Care (FREAP)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=64 Participants Normal primary care treatment	Total n=129 Participants Total of all reporting groups	Standardized Respiratory Physiotherapy n=65 Participants Standardized Respiratory Physiotherapy is the intervention in all selected patients
Age, Categorical <=18 years	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=20 Participants	51 Participants n=40 Participants	25 Participants n=20 Participants
Age, Categorical >=65 years	38 Participants n=20 Participants	78 Participants n=40 Participants	40 Participants n=20 Participants
Age, Continuous	59.8 years STANDARD_DEVIATION 9.1 • n=20 Participants	60.4 years STANDARD_DEVIATION 8.3 • n=40 Participants	60.8 years STANDARD_DEVIATION 7.8 • n=20 Participants
Sex: Female, Male Female	21 Participants n=20 Participants	35 Participants n=40 Participants	14 Participants n=20 Participants
Sex: Female, Male Male	43 Participants n=20 Participants	94 Participants n=40 Participants	51 Participants n=20 Participants
Region of Enrollment Spain	64 participants n=20 Participants	129 participants n=40 Participants	65 participants n=20 Participants

PRIMARY outcome

Timeframe: Six months

Population: 7 participants were excluded from the analysis

The questionnaire is designed to measure the impact of respiratory symptoms and their treatment on a patient's daily life. It consists of various sections that cover a range of topics related to respiratory health, including symptoms, activity limitations, and overall well-being. The SGRQ questionnaire has 50 items with 76 weighted responses. Scores range from 0 to 100, with higher scores indicating more limitations.

Outcome measures

Outcome measures
Measure	Standardized Respiratory Physiotherapy n=62 Participants Standardized Respiratory Physiotherapy is the intervention in all selected patients	Control Group n=60 Participants Usual clinical practice
St-George Respiratory Questionnaire-SGRQ	29.6 score on a scale Standard Deviation 20.5	38 score on a scale Standard Deviation 21.1

PRIMARY outcome

Timeframe: 6 month

The BODE index is a clinical tool used to assess the severity of chronic obstructive pulmonary disease (COPD) and predict the risk of mortality in individuals with this respiratory condition. The BODE Index is a 0 to 10-point scale and it is based on four factors: * Body Mass Index (BMI) * Airflow obstruction (FEV1, as a percentage of the predicted value) * Dyspnea (measured using the MRC dyspnea scale, which ranges from 0 to 4) * Exercise capacity (measured by the 6-minute walk test, in meters) Each factor is assigned a score from 0 to 3 (except for BMI, which can only receive 0 or 1). The total score ranges from 0 to 10, with higher values indicating greater severity and a worse prognosis for COPD.

Outcome measures

Outcome measures
Measure	Standardized Respiratory Physiotherapy n=62 Participants Standardized Respiratory Physiotherapy is the intervention in all selected patients	Control Group n=60 Participants Usual clinical practice
BODE Index	1.52 score on a scale Standard Deviation 1.35	1.77 score on a scale Standard Deviation 1.47

Adverse Events

Standardized Respiratory Physiotherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Maria Montserrat Inglés Novell

Catalan Health Institute

Phone: +34 977252808

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place