Pulmonary Rehabilitation After Minimal Invasive Surgery in Lung Cancer

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05136300

Acronym

PROMISE

Enrollment

100

Registered

2021-11-29

Start date

2019-05-01

Completion date

2023-07-01

Last updated

2022-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Surgery

Brief summary

Morbidity in the post-operative phase of pulmonary surgery is characterised by impairment due to pain, dyspnoea and loss of exercise tolerance. We demonstrated previously that rehabilitation after thoracotomy is limited due to pain. Since minimal invasive surgery is the new standard in lung cancer, resulting in a reduction of postoperative pain, we believe there are new possibilities for post-operative integrated multidisciplinary rehabilitation in lung cancer.

Interventions

BEHAVIORALPulmonary rehabilitation

Patients in the intervention group will receive physical therapy, scheduled pain monitoring and coaching by a social worker. The intensity of the rehabilitation training program will be determined separately for each patient by a steepramp and 1-repetition test within 3 weeks post-operative. The intervention group will be trained and educated in 2 sessions of 2 hours per week, for a period of 3 months.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

RCT

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Patients undergoing elective, minimal invasive surgery with intention to cure. 2. Age between 18 and 80 years. 3. ECOG 0 - 2 post-surgery.

Exclusion criteria

1. Patients with chronic pain 2. Previous pulmonary surgery 3. Comorbidity limiting rehabilitation 1. Rheumatoid arthritis 2. Severe ischaemic heart disease or myocardial failure; EF ≤ 35 %. 3. Muscle disease 4. Fibromyalgia 5. Neurologic disorders (Parkinson disease, CVA and lesions of the spinal cord) 6. Psychiatric disorders

Design outcomes

Primary

Measure	Time frame	Description
Quality of life (SF-36)	12 months	effects of an integrated multidisciplinary rehabilitation program on general quality of life

Secondary

Measure	Time frame	Description
SGRQ	12 months	health-related quality of life
VAS	12 months	post-operative pain
WHO-PS	12 months	performance score
6 minute walking distance	12 months	exercise tolerance
international physical activity questionnaire, iPAQ	12 months	physical activity

Countries

Netherlands

Contacts

Primary ContactLars Dinjens

ldinjens@isala.nl0384244597

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026