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NCT Number: NCT06732869

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

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.

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Key information

Conditions

COPD Behavior Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Physical Activity Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Innovative Care and Health Technology (ciTechCare), Polytechnic of Leiria

Leiria, 2414-016, Portugal

Location status: Recruiting

Location contact

Maria Guarino

CONTACT

[email protected]

+351 244845050

About this study

This randomized controlled trial aims 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 10 weeks. At week 5 of the rehabilitation program, the experimental group will receive a physical activity coaching intervention, which will continue for 6 months following its completion. This intervention will include an eHealth platform divided into two applications (a mobile app for patients and a web app for researchers/healthcare professionals).

Goal setting and progression according to patients' performance and willingness to increase will occur every week, through phone calls. Barriers to physical activity and strategies to overcome them will be identified between the patient and researcher, during the goal-setting moments. Notifications about PA goals achievement and incentives will be sent to patients during the intervention.

The assessment moments will be conducted at the beginning, midway, and end of the pulmonary rehabilitation program, as well as 3- and 6 months after its conclusion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • being able to understand and provide informed consent.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Accelerometry (number of daily steps)

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

    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.

Secondary outcomes

  1. 6-Minute Walk Test (exercise capacity)

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

    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.

  2. modified Medical Research Council (Dyspnoea)

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

    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'.

  3. Checklist of Individual Strength (Fatigue)

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

    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.

  4. COPD Assessment Test (Impact of symptoms on health status)

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

    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.

  5. MOS Short-Form Health Survey 36 Item v2 (SF-36) (Quality of Life)

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

    Quality of Life will be assessed with MOS Short-Form Health Survey 36 Item v2 (SF-36). The SF-36 is widely used to measure perceived health-related quality of life. The instrument includes scales for physical functioning, social functioning, limitations in function due to physical or emotional problems, mental health, energy, pain and general perception of health. The score ranges from 0 - 100 (higher scores indicate better levels of quality of life.

  6. Physical Exercise Self-Efficacy Scale (self-efficacy for PA)

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

    self-efficacy for PA will be assessed with Physical Exercise Self-Efficacy Scale which consists of 5 items that analyse an individual's confidence in performing physical exercise according to different emotional states (worried, depressed, nervous, tired and busy). The total score is the sum of the scores for each item, ranging from 5 to 20. The higher the score, the greater the belief or sense of self-efficacy for exercise.

Study contacts

Contact information is provided by the study sponsor or research team.

Joana Cruz, PT, PhD

CONTACT

[email protected]

969196218

Sofia Flora, PT, MSc

CONTACT

[email protected]

+351 917257840

Sponsors and collaborators

Lead sponsor

Instituto Politécnico de Leiria

Other

Collaborators

  • Faculdade de Motricidade Humana de Lisboa
  • Unidade Local de Saúde de Lisboa Norte
  • Unidade Local de Saúde do Baixo Mondego

Registry information

Official study title

PACE - Physical Activity in COPD Using E-Health: Effectiveness of a Personalised eHealth Platform Integrated Into Pulmonary Rehabilitation to Increase Physical Activity in Patients With COPD - a Randomized Controlled Trial

Acronym: PACE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 13, 2024
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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