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Relaxation and Exercise In Lymphoma Patients (REIL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02272751
Recruitment Status : Completed
First Posted : October 23, 2014
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
St George's, University of London

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).

Behavioral: Exercise
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).

Behavioral: Relaxation
The Relaxation intervention will consist of a chair-based program incorporating breathing exercises, meditation, visualisation and progressive muscle relaxation.
Other Name: Mindfulness




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


  2. 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.

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with histologically confirmed lymphoma in remission post-chemotherapy
  2. Age 18 years or older
  3. Ability to give informed consent
  4. Good Performance status (ECOG 0-2)
  5. Clinically able to carry out exercise training programme on a regular basis

Exclusion Criteria:

  1. Patients with progressive disease
  2. Poor performance status (ECOG status 3 or more)
  3. Abnormal resting ECG unexplained by further cardiological investigations
  4. Pregnancy
  5. Difficulty breathing at rest
  6. Persistent cough, fever or illness
  7. Cognitive impairment sufficient to limit ability to perform quality of life questionnaires or understand instructions

Information from the National Library of Medicine

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


Locations
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United Kingdom
Haematology and Oncology Outpatient Clinic, St. George's Hospital, Blackshaw Road
Tooting, London, United Kingdom, SW17 0QT
Sponsors and Collaborators
St George's, University of London
Investigators
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Principal Investigator: Ruth Pettengell, MBChB PhD St George's, University of London
Study Director: Ahmed Younis, PhD St George's, University of London

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: St George's, University of London
ClinicalTrials.gov Identifier: NCT02272751    
Other Study ID Numbers: 13.0108
First Posted: October 23, 2014    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be submitted for publication, undecided re: individual participant data
Keywords provided by St George's, University of London:
cancer survivorship
exercise
relaxation
mindfulness
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases