Relaxation and Exercise In Lymphoma Patients (REIL)

February 19, 2019 updated by: St George's, University of London

A Comparison of Exercise Training With Relaxation Intervention in Lymphoma Patients Post-chemotherapy.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Significant improvements have been made in the survival rates in cancer patients. Due to factors such as screening and earlier detection of cancer and advances in treatment, cancer today is a curable disease for many. However, cancer survivors are at a significantly increased risk of morbidity and adverse effects due to treatment exposures. Commonly reported consequences of cancer treatment include fatigue, pain, depression, anxiety, reduced performance status and decreased quality of life Hence cancer today is considered more as a chronic illness, and there is increasing research being carried out on cancer survivorship and recommendations for survivorship care pathways to include interventions to enhance both physical and psychosocial functioning in cancer survivors.

Previous studies have demonstrated that both exercise and interventions such as relaxation have a positive effect on both physical and psychosocial complaints of cancer survivors. These interventions are carried out in different ways, have different requirements and perceptions of the two can also be very different. No trial to date has been carried out comparing the effects of these interventions on the quality of life in cancer survivors. Furthermore, majority of the above research has been carried out on the most prevalent cancers including breast cancer, prostate cancer and colorectal cancer, and several authors have called for future research to focus on other understudied survivor groups, including haematologic cancer sites. This study aims to compare the effect of exercise and relaxation interventions on quality of life in lymphoma survivors.

The aim of the present study is to compare the effects of an Exercise Intervention Program with a Relaxation Intervention in a sample of lymphoma patients in remission post-chemotherapy.

Eligible subjects will be randomised to one of two arms - either an exercise or a relaxation arm. Both arms comprise of a home programme of their intervention (either exercise or relaxation) for half an hour, carried out three times a week. Subjects are assessed using the primary and secondary outcome measures at baseline, midway (6 weeks) and at the end of the intervention (12 weeks). It is hypothesised that a 12 week training programme of both exercise and relaxation would improve the quality of life of lymphoma survivors, however the exercise programme would result in a significantly greater improvement than relaxation. The null hypothesis would state that there would be no significant difference between exercise or relaxation groups following a 12 week training programme in lymphoma survivors.

The aims of the study are as follows:

Primary aim

To compare the effectiveness of Exercise with Relaxation in the improvement of overall wellbeing and quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30).

Secondary aims

To determine whether these interventions result in:

  • Improved cardio-respiratory fitness (resting HR and BP) and pulmonary function (spirometry)
  • Improved fitness and exercise tolerance using the 6 Minute Walk Test
  • Improved emotional and functional confidence as measured by the Health related quality of life questionnaire Functional Assessment of Cancer Therapy Lymphoma version (FACT-Lym)
  • Decreased anxiety and depression levels using the Hospital Anxiety and Depression Scale (HADS)
  • Changes in haematology (haemoglobin, immunoglobulins, white count) and biochemical (serum albumin, corrected calcium, creatinine) parameters
  • Compare the results of the above outcome measures between the two interventions
  • Analyse subject perceptions of interventions in focus groups

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • London
      • Tooting, London, United Kingdom, SW17 0QT
        • Haematology and Oncology Outpatient Clinic, St. George's Hospital, Blackshaw Road

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Mindfulness

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 weeks and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 weeks and 12 weeks
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.
Baseline, 6 weeks and 12 weeks
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.
Baseline, 6 weeks and 12 weeks
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.
Baseline, 6 weeks and 12 weeks
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.
Baseline, 6 weeks and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St George's, University of London

Investigators

  • Principal Investigator: Ruth Pettengell, MBChB PhD, St George's, University of London
  • Study Director: Ahmed Younis, PhD, St George's, University of London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

October 16, 2014

First Submitted That Met QC Criteria

October 21, 2014

First Posted (Estimate)

October 23, 2014

Study Record Updates

Last Update Posted (Actual)

February 20, 2019

Last Update Submitted That Met QC Criteria

February 19, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13.0108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be submitted for publication, undecided re: individual participant data

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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