LymphomaREILNCT02272751
Relaxation and Exercise In Lymphoma Patients
A study testing Exercise and Relaxation in people with Lymphoma and Quality of Life, run by St George's, University of London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Quality of Life
- What is being tested?
- Exercise and Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2014to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically confirmed lymphoma in remission post-chemotherapy
- Age 18 years or older
- Ability to give informed consent
- Good Performance status (ECOG 0-2)
- Clinically able to carry out exercise training programme on a regular basis
Who cannot join
- Patients with progressive disease
- Poor performance status (ECOG status 3 or more)
- Abnormal resting ECG unexplained by further cardiological investigations
- Pregnancy
- Difficulty breathing at rest
- Persistent cough, fever or illness
- Cognitive impairment sufficient to limit ability to perform quality of life questionnaires or understand instructions
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Haematology and Oncology Outpatient Clinic, St. George's Hospital, Blackshaw Road
Tooting, London, SW17 0QT
About this study
Official title: 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.
Read the 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
- Conditions
- Lymphoma, Quality of Life
- Being tested
- Exercise, Relaxation
- Keywords
- cancer survivorship, exercise, relaxation, mindfulness
- Medical subject headings
- Lymphoma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Also called Exercise Training
The Exercise intervention will consist of aerobic activity followed by upper and lower limb resistance training using Therabands and some core exercises.
RelaxationBehavioural
Also called Mindfulness
The Relaxation intervention will consist of a chair-based program incorporating breathing exercises, meditation, visualisation and progressive muscle relaxation.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Experimental | 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). Receives: Behavioral: Exercise |
| Relaxation Intervention | Experimental | 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). Receives: Behavioral: Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
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.
Measured: Baseline, 6 weeks and 12 weeks
Secondary outcomes (5)
Change in Six Minute Walk Test distance and Heart Rate
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.
Measured: Baseline, 6 weeks and 12 weeks
Change in Grip Strength
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.
Measured: Baseline, 6 weeks and 12 weeks
Change in Spirometry values
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.
Measured: Baseline, 6 weeks and 12 weeks
Change in FACT-Lym Questionnaire
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.
Measured: Baseline, 6 weeks and 12 weeks
Change in Hospital Anxiety and Depression Scale
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.
Measured: Baseline, 6 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruth Pettengell, MBChB PhD, Principal investigator, St George's, University of LondonAhmed Younis, PhD, Study director, St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272751
- Sponsor's protocol ID
- 13.0108
- Acronym
- REIL
- Status last verified
- Feb 2019
- First submitted
- 16 Oct 2014
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Data will be submitted for publication, undecided re: individual participant data
Publications
Hathiramani S, Pettengell R, Moir H, Younis A. Relaxation versus exercise for improved quality of life in lymphoma survivors-a randomised controlled trial. J Cancer Surviv. 2021 Jun;15(3):470-480. doi: 10.1007/s11764-020-00941-4. Epub 2020 Sep 28.
PubMed 32986231Hathiramani S, Pettengell R, Moir H, Younis A. Relaxation and exercise in lymphoma survivors (REIL study): a randomised clinical trial protocol. BMC Sports Sci Med Rehabil. 2019 Aug 16;11:17. doi: 10.1186/s13102-019-0127-7. eCollection 2019.
PubMed 31428434
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Exercise Training With Relaxation Intervention in Lymphoma Patients Post-chemotherapy.
- ClinicalTrials.gov ID
- NCT02272751
- Acronym / sponsor ID
- REIL / 13.0108
- Conditions
- Lymphoma, Quality of Life
- Keywords
- cancer survivorship, exercise, relaxation, mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 23 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Experimental | Behavioral: ExerciseSubjects 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). |
| Relaxation Intervention | Experimental | Behavioral: RelaxationSubjects 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with histologically confirmed lymphoma in remission post-chemotherapy
- Age 18 years or older
- Ability to give informed consent
- Good Performance status (ECOG 0-2)
- Clinically able to carry out exercise training programme on a regular basis
Key exclusion criteria (7 listed)
- Patients with progressive disease
- Poor performance status (ECOG status 3 or more)
- Abnormal resting ECG unexplained by further cardiological investigations
- Pregnancy
- Difficulty breathing at rest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: Exercise TrainingThe Exercise intervention will consist of aerobic activity followed by upper and lower limb resistance training using Therabands and some core exercises. | Behavioural | Exercise Intervention |
| RelaxationAlso: MindfulnessThe Relaxation intervention will consist of a chair-based program incorporating breathing exercises, meditation, visualisation and progressive muscle relaxation. | Behavioural | Relaxation Intervention |
Primary outcome
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.
5 secondary outcomes
Change in Six Minute Walk Test distance and Heart Rate
Time frame: Baseline, 6 weeks and 12 weeks
Change in Grip Strength
Time frame: Baseline, 6 weeks and 12 weeks
Change in Spirometry values
Time frame: Baseline, 6 weeks and 12 weeks
Change in FACT-Lym Questionnaire
Time frame: Baseline, 6 weeks and 12 weeks
Change in Hospital Anxiety and Depression Scale
Time frame: Baseline, 6 weeks and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
- Derived from this study: PubMed 32986231Hathiramani S, Pettengell R, Moir H, Younis A. Relaxation versus exercise for improved quality of life in lymphoma survivors-a randomised controlled trial. J Cancer Surviv. 2021 Jun;15(3):470-480. doi: 10.1007/s11764-020-00941-4. Epub 2020 Sep 28.
- Derived from this study: PubMed 31428434Hathiramani S, Pettengell R, Moir H, Younis A. Relaxation and exercise in lymphoma survivors (REIL study): a randomised clinical trial protocol. BMC Sports Sci Med Rehabil. 2019 Aug 16;11:17. doi: 10.1186/s13102-019-0127-7. eCollection 2019.
- Individual participant dataSharing planned: No. Data will be submitted for publication, undecided re: individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth Pettengell, MBChB PhD principal investigator
St George's, University of London
Ahmed Younis, PhD study director
St George's, University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Relaxation in people with Lymphoma and Quality of Life, run by St George's, University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02272751, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2019.