Lymphoma Clinical Trial
— REILOfficial title:
A Comparison of Exercise Training With Relaxation Intervention in Lymphoma Patients Post-chemotherapy.
NCT number | NCT02272751 |
Other study ID # | 13.0108 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2014 |
Est. completion date | March 2017 |
Verified date | February 2019 |
Source | St George's, University of London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 41 |
Est. completion date | March 2017 |
Est. primary completion date | March 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Haematology and Oncology Outpatient Clinic, St. George's Hospital, Blackshaw Road | Tooting | London |
Lead Sponsor | Collaborator |
---|---|
St George's, University of London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline, 6 weeks and 12 weeks | |
Secondary | 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. |
Baseline, 6 weeks and 12 weeks | |
Secondary | 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. | Baseline, 6 weeks and 12 weeks | |
Secondary | 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. | Baseline, 6 weeks and 12 weeks | |
Secondary | 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. | Baseline, 6 weeks and 12 weeks | |
Secondary | 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. | Baseline, 6 weeks and 12 weeks |
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