NCT02272751

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable lymphoma

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 23, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

February 20, 2019

Status Verified

February 1, 2019

Enrollment Period

2.5 years

First QC Date

October 16, 2014

Last Update Submit

February 19, 2019

Conditions

LymphomaQuality of Life

Keywords

cancer survivorshipexerciserelaxationmindfulness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change in Six Minute Walk Test distance and Heart Rate

    Baseline, 6 weeks and 12 weeks

  • Change in Grip Strength

    Baseline, 6 weeks and 12 weeks

  • Change in Spirometry values

    Baseline, 6 weeks and 12 weeks

  • Change in FACT-Lym Questionnaire

    Baseline, 6 weeks and 12 weeks

  • Change in Hospital Anxiety and Depression Scale

    Baseline, 6 weeks and 12 weeks

Study Arms (2)

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).

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).

Behavioral: Relaxation

Interventions

ExerciseBEHAVIORAL

The Exercise intervention will consist of aerobic activity followed by upper and lower limb resistance training using Therabands and some core exercises.

Also known as: Exercise Training
Exercise Intervention
RelaxationBEHAVIORAL

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

Also known as: Mindfulness
Relaxation Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haematology and Oncology Outpatient Clinic, St. George's Hospital, Blackshaw Road

Tooting, London, SW17 0QT, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 32986231DERIVED

  • Hathiramani 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.

    PMID: 31428434DERIVED

MeSH Terms

Conditions

LymphomaMotor Activity

Interventions

ExerciseMindfulness

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Ruth Pettengell, MBChB PhD

    St George's, University of London

    PRINCIPAL INVESTIGATOR

  • Ahmed Younis, PhD

    St George's, University of London

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2014

First Posted

October 23, 2014

Study Start

September 1, 2014

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

February 20, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

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

Locations

GB(1)