Effectiveness of a Physical ACtivity Coaching Intervention Using E-Health for COPD Patients in Pulmonary Rehabilitation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorInstituto Politécnico de Leiria

About this trial

The goal of this randomized controlled trial is to evaluate the efficacy of a physical activity coaching intervention - delivered through an eHealth platform both during and after pulmonary rehabilitation - to enhance physical activity levels and health-related outcomes in patients with Chronic Obstructive Pulmonary Disease (COPD). All participants will attend the pulmonary rehabilitation program for 2 months; the experimental group will receive a physical activity coaching intervention at the end of the 1st month of the rehabilitation program, which will continue for 6 months following the completion of the program. Assessments will be conducted at the beginning, midway, and at the end of the coaching program, as well as 3 months and 6 months after its conclusion.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age > 40 years old

diagnosis of COPD according to GOLD criteria, clinically stable (i.e., with no exacerbations in the previous month)

being enrolled in a pulmonary rehabilitation program

having a smartphone with access to the internet

Disqualifiers

simultaneous participation in another behavioural modification program

having any clinical condition that precludes participation in a PA intervention (e.g., severe musculoskeletal or neurological disorders and unstable cardiovascular disease)

another primary respiratory disease

history of recent neoplasia (including last treatment) in the previous year.

Trial design

Design model

Parallel

Treatments tested in this trial

  • eHealth physical activity coaching intervention

    Behavioral

    Patients will attend a PR program and in week 5 of PR will receive an eHealth PA coaching intervention until 6 months after end of PR. The PA goals will be prescribed through a phone call and the personalisation of goal prescription will be based on an algorithm considering patient's performance in the previous week, perceived easiness of achieving the previous goal and confidence to change it. If patient does not achieve the goal, reasons, barriers to PA and strategies to overcome them will be identified. Patients will receive a daily notification about their goal achievements, at 6PM every day, giving them the possibility to increase their PA to achieve the goal, if they have not reached it yet. Patients will also receive personalized notifications sent manually by the researcher whenever appropriate. PA goals will be prescribed on a weekly basis.

  • pulmonary rehabilitation

    Behavioral

    Patients will attend pulmonary rehabilitation program for 10 weeks. Pulmonary rehabilitation is evidence-based multidisciplinary intervention based on thorough patient assessment followed by patient-tailored therapies that include, but are not limited to exercise training, education, self-management intervention aiming at behaviour change, known to improve health status and psychological well-being, reducing dyspnoea and healthcare utilization and hospitalization. In this study, pulmonary rehabilitation programs will have 20 sessions, twice a week, including exercise training (aerobic and strength training), educational sessions about topics as medication, smoking cessation, energy conservation techniques, physical activity, stress and anxiety management, breathing control, inhaled therapy and nutrition; nutritional and psychosocial counselling. Education session about PA importance and recommendations will be also provided in both arms.

Treatment groups

57 Participants
are divided into 2 treatment groups
Group A: Experimental Group - Pulmonary rehabilitation + eHealth physical activity coaching interventionExperimental treatment 2 interventions
Group B: Control group - pulmonary rehabilitationOther 1 intervention

Trial outcomes

Primary outcomes

1

Accelerometry (number of daily steps)

PA will be objectively measured using the triaxial accelerometer Actigraph GT3X+, already validated in COPD. Patients will be instructed to wear the accelerometer for 7 days on the dominant side of their waist, held by an elastic strap, during waking hours, except for bathing or swimming. A valid day will be defined as a minimum of 8 hours of wearing time, and patients will need to have at least 4 valid days in each moment of data collection. Accelerometer-based data will be then downloaded and analysed using the algorithms of Freedson (1998) with 60-s epoch: daily time (in min) spent in light-intensity PA, moderate, vigorous and a combination of both. The number of steps per day and per week will also be collected, being the main outcome of the study.

Time frame
weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion

Secondary outcomes

1

6-Minute Walk Test (exercise capacity)

Functional exercise capacity was measured using 6MWT, and predicted values were computed using the equation developed for Portuguese adults. The test will be conducted according to guidelines from ERS/ATS.

Time frame
weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion
2

modified Medical Research Council (Dyspnoea)

Dyspnoea was assessed through the modified Medical Research Council (mMRC), on a scale from 0 to 4, in which 0 means 'dyspnoea only with strenuous exercise' and 4 means 'too dyspnoeic to leave house or breathless when dressing'.

Time frame
weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion
3

Checklist of Individual Strength (Fatigue)

Fatigue will be assessed with the Checklist of Individual Strength (CIS20). This questionnaire consists of four dimensions (Subjective Fatigue, Concentration, Motivation and Physical Activity) that assess the fatigue severity.

Time frame
weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion
4

COPD Assessment Test (Impact of symptoms on health status)

The COPD Assessment Test is designed to measure the impact of COPD on a person's life, and how this changes over time.The total score is a sum of the 8 questions. Higher scores indicates worse impact of the disease.

Time frame
weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion

Other outcomes

Sponsors and contacts

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Instituto Politécnico de Leiria

Lead sponsor

Unidade Local de Saúde do Baixo Mondego

Collaborator

Unidade Local de Saúde de Lisboa Norte

Collaborator

Faculdade de Motricidade Humana de Lisboa

Collaborator