Feasibility and Effect of a Follow up Tele-rehabilitation Program for Chronic Obstructive Lung Disease vs. Standard Follow up

NCT03443817 | Unknown

• 1 other identifier: 2-KOL
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction In order to guarantee chronic patients \& elderly a high quality service from health care organizations in the coming decades, new technologies have been implemented to treat patients from a distance. There is still a need for more studies on the efficacy and cost-effectiveness of tele-rehabilitation (TR) and its long-term effects needs also to be determined. To guarantee individuals with chronic obstructive pulmonary diseases (COPD) a high quality service from health care organizations in the coming decades and economically save the national health systems for an expensive bill for the treatment of COPD, new actions plans has to be taken into use. Hereby, more patients can be treated with less human resources while still sustaining or even improving today's services. The importance of such welfare action plans has to maintain a high quality of service that individuals with COPD are willing to accept. Here, TR seems to be a good welfare action plans. Despite proof of improved cost-effectiveness, no studies support the benefits of TR in COPD patient with respect to adherence, security, treatment efficacy and improved quality of life. Aim To assess and compare the feasibility and effect of a tele-rehabilitation program with a new and innovative TR platform (NITRP) compared to standard treatment with respect to exercise capacity, quality of life and activities of daily living in patients with COPD. Method and material The study is a prospective randomized controlled trial comparing the effects of a follow-up tele-rehabilitation program and conventional follow-up rehabilitation in patients with severe COPD. 54 patients fulfilling the inclusion criteria will be randomized in two groups to either an 8 week follow-up tele-rehabilitation program or to standard follow up after rehabilitation. Participants will be tested at baseline, after 8 weeks and 6 months after cessation of the training programs. In the intervention group, a real- and a virtual physiotherapist agent will facilitate the rehabilitation. Ethical considerations This study will not pose any risk to the patient as compared to current practice. Participation is voluntary and the patient may at any time withdraw from the study without consequences for future care or treatment. The questionnaires and the test methods used are clinically recognized instruments. Signed informed consent will be obtained from the all participants after verbal and written information and before the study starts. The study will not be initiated before approval from the Ethics Committee and the Data Protection Agency has been obtained. The study will follow the general research ethical rules as expressed in the Helsinki Declaration II.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Feasibility; tele-rehabilitation; follow-up; COPD

Outcome Measures

Primary Outcomes (1)

• 6 minute walk test

  Change in the 6 minute walk test

  measured at week 8

Secondary Outcomes (5)

• 6 minute walk test

  6 months after cessation

• Health-related quality of life

  8 weeks, and 6 months after cessation

• Generalised Anxiety Disorder Assessment (GAD-7)

  8 weeks, and 6 months after cessation

• health-related quality of life measured by SGRQ

  6 months after cessation

• Cost tele-rehab

  6 months

Study Arms (2)

Control group

NO INTERVENTION

There is no conventional rehabilitation follow up program, but all patients are encouraged to continue training

Intervention group

EXPERIMENTAL

The intervention group will obtain telerehabilitation

Behavioral: Tele rehab

Interventions

Tele rehab BEHAVIORAL

Video Consultation (VC) Sessions: Each patient will have the opportunity to have minimum one VC per week the first month, one VC each second week the second month one VC a month Retraining breath: Patients will also be instructed to use different techniques to breath during the video consultations with the physiotherapist. Chat Sessions: Each patient has the opportunity to chat with the physiotherapist any time via the chat module of the system. Workout Sessions with a Virtual Physiotherapist Agent (VPA): The patient will train according to what is decided by the physiotherapist and the patient in the VC or chat meetings. Normally, the patients will train 10-20 minutes daily at home with its individual and tailored VPA. Patients' security: In order to minimize the risks of possible accidents while performing the exercises, the patient will answer questions before and after each exercise performance that the physiotherapist can follow in real time.

Intervention group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stable COPD
• Signed informed consent
• Completion of the standard rehabilitation program
• Permanent oxygen therapy is not an obstacle for participation.

You may not qualify if:

• The patient has significant musculoskeletal disorders that limit his / her function levels to a degree that is not caused by dyspnea
• The patient has pronounced dizziness, significant sensory or motor disability, dementia or terminal malignant disease
• Serious comorbidities (unstable heart disease, irregular diabetes, known malignant disease, another disease that makes the patient unfit to participate in the study).
• Non-compliant patient (eg. Nursing Homes Residents)
• Participation in another project within the last 30 days
• Mini-Mental State Examination score less than 24 points
• Severe vision or hearing loss.
• Non-Danish speaking.
• Lack of will to implement the protocol.
• Motor or sensory disease, which makes it impossible for walk training
• Have experienced a worsening in the last 4-6 weeks
• Musculoskeletal disorders
• Serious heart diseases (ejection fraction \<30%, daily angina, or as indicated by treating the cardiologist)
• Can not understand informed consent
• Other factors that inhibit the use of telerehabilitation

Sponsors & Collaborators

• University of Aarhus: lead
• Eurostars: collaborator

Study Sites (1)

Jose Cerdan

Aarhus, Danmark, 8000, Denmark

RECRUITING

Related Publications (3)

• Tsai LL, McNamara RJ, Moddel C, Alison JA, McKenzie DK, McKeough ZJ. Home-based telerehabilitation via real-time videoconferencing improves endurance exercise capacity in patients with COPD: The randomized controlled TeleR Study. Respirology. 2017 May;22(4):699-707. doi: 10.1111/resp.12966. Epub 2016 Dec 19.

  PMID: 27992099 BACKGROUND

• Zanaboni P, Dinesen B, Hjalmarsen A, Hoaas H, Holland AE, Oliveira CC, Wootton R. Long-term integrated telerehabilitation of COPD Patients: a multicentre randomised controlled trial (iTrain). BMC Pulm Med. 2016 Aug 22;16(1):126. doi: 10.1186/s12890-016-0288-z.

  PMID: 27549782 BACKGROUND

• Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.

  PMID: 33511633 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Jose Cerdan

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose Cerdan, PhD stud

CONTACT

+4530648283; joscer@rm.dk

Elisabeth Bendstrup, MD,Ph.d

CONTACT

+45 7846 2201; karbends@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective randomized controlled trial comparing the effects of a follow-up tele-rehabilitation program and conventional follow-up rehabilitation in patients with severe COPD. 54 patients fulfilling the inclusion criteria will be randomized in two groups to either an 8 week follow-up tele-rehabilitation program or to standard follow up after rehabilitation. Participants will be tested at baseline, after 8 weeks and 6 months after cessation of the training programs. In the intervention group, a real- and a virtual physiotherapist agent will facilitate the rehabilitation.

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: February 23, 2018
• Study Start: March 1, 2018
• Primary Completion: December 30, 2020
• Study Completion: January 30, 2021
• Last Updated: February 28, 2018

Record last verified: 2018-02

Locations

DK (1)