Relaxation and Exercise In Lymphoma Patients (REIL)
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|ClinicalTrials.gov Identifier: NCT02272751|
Recruitment Status : Completed
First Posted : October 23, 2014
Last Update Posted : February 20, 2019
This study will aim to compare the effects of an Exercise programme and a Relaxation Intervention in lymphoma patients in remission post-chemotherapy on quality of life, cardiovascular fitness, exercise tolerance, muscle strength, psychological status, social well-being and biological markers.
Subjects will be recruited from a specialist lymphoma clinic in South West London and randomly allocated to an exercise or a relaxation home programme. The study aims to determine the more effective intervention of the two in relation to the outcome measures.
The investigators anticipate that the interventions will result in less adverse events and improved quality of life and physical fitness, and subjects will require less medication, less counseling and cancer nurse specialist care, leading to leading to a reduction in hospital and surgery attendances.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma Quality of Life||Behavioral: Exercise Behavioral: Relaxation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Comparison of Exercise Training With Relaxation Intervention in Lymphoma Patients Post-chemotherapy.|
|Actual Study Start Date :||September 2014|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||March 2017|
Experimental: Exercise Intervention
Subjects allocated to the Exercise arm will aim to undertake a personal prescribed home exercise programme for half an hour three times a week.
Exercises will be progressed at 6 weeks as subjects progress. All exercise sessions will be documented in the logbooks provided.
Outcome measures will be assessed at baseline, mid-way (6 weeks) and at the end of intervention (12 weeks).
The Exercise intervention will consist of aerobic activity followed by upper and lower limb resistance training using Therabands and some core exercises.
Other Name: Exercise Training
Experimental: Relaxation Intervention
Subjects allocated to the Relaxation arm will aim to undertake a guided relaxation programme on a CD for half an hour three times a week.
All relaxation sessions will be documented in the logbooks provided. Outcome measures will be assessed at baseline, mid-way (6 weeks) and at the end of intervention (12 weeks).
The Relaxation intervention will consist of a chair-based program incorporating breathing exercises, meditation, visualisation and progressive muscle relaxation.
Other Name: Mindfulness
- Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) [ Time Frame: Baseline, 6 weeks and 12 weeks ]The EORTC-QLQ-C30 is a self-administered questionnaire which assesses aspects of function, symptoms, and global health and QOL in samples of cancer patients. It has been demonstrated to be a valid and reliable tool in the literature, takes approximately eleven minutes to complete and most subjects require no assistance.
- Change in Six Minute Walk Test distance and Heart Rate [ Time Frame: Baseline, 6 weeks and 12 weeks ]
The Six Minute Walk Test (6MWT) is a valid and reliable tool used in a variety of clinical settings, and validated for use with cancer patients. The patient is read out a set of standardised instructions to walk around a measured distance continuously as fast as they can for six minutes. Following this, the distance covered is measured and recorded, as well as their Heart Rate, Saturations, Rate of Perceived Exertion and Dyspnoea (using Borg scales) are recorded.
This test gives an indication of general fitness and overall function.
- Change in Grip Strength [ Time Frame: Baseline, 6 weeks and 12 weeks ]Grip strength will be determined using hand-held dynamometry following a set of standardised guidelines. This is a common method that is used extensively to assess general strength characteristics.
- Change in Spirometry values [ Time Frame: Baseline, 6 weeks and 12 weeks ]Measures of pulmonary capacity and function including Forced Vital Capacity (FVC), Forced Expiratory Volume in one second (FEV1), Forced Expiratory Ratio (FER) and Peak Expiratory Flow (PEF) will be taken via microspirometry.
- Change in FACT-Lym Questionnaire [ Time Frame: Baseline, 6 weeks and 12 weeks ]The Functional Assessment of Chronic Illness questionnaires, have been validated in studies of cancer management and are designed to encompass the whole range of psychosocial factors. Here, the lymphoma-specific (FACT-Lym) self-administered questionaire will be used.
- Change in Hospital Anxiety and Depression Scale [ Time Frame: Baseline, 6 weeks and 12 weeks ]The Hospital Anxiety and Depression Scale (HADS) is a valid tool for the identification of psychiatric complications of cancer such as depression, anxiety or distress in cancer settings. It is a self-administered questionnaire.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272751
|Haematology and Oncology Outpatient Clinic, St. George's Hospital, Blackshaw Road|
|Tooting, London, United Kingdom, SW17 0QT|
|Principal Investigator:||Ruth Pettengell, MBChB PhD||St George's, University of London|
|Study Director:||Ahmed Younis, PhD||St George's, University of London|