NCT00111865

Brief Summary

Objectives: The primary objective of this trial is to determine the effect of aerobic exercise training (AET) on change in quality of life (QoL) in lymphoma survivors receiving and not receiving chemotherapy. Secondary objectives are to determine the effects of AET on changes in psychosocial outcomes, cardiopulmonary fitness, body composition, and treatment completion rates.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
122

participants targeted

Target at below P25 for phase_3 lymphoma

Timeline
Completed

Started Apr 2005

Shorter than P25 for phase_3 lymphoma

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 27, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

August 26, 2008

Status Verified

August 1, 2008

Enrollment Period

3.3 years

First QC Date

May 26, 2005

Last Update Submit

August 22, 2008

Conditions

Lymphoma

Keywords

physical exercisequality of lifelymphoma

Outcome Measures

Primary Outcomes (1)

  • Change in QoL between baseline and postintervention.

    12 weeks

Secondary Outcomes (4)

  • Changes in cardiopulmonary fitness

    12 weeks

  • psychosocial outcomes

    12 weeks

  • body composition

    12 weeks

  • treatment completion rates

    12 weeks

Study Arms (2)

Exercise

EXPERIMENTAL

Aerobic Exercise Training

Behavioral: Aerobic Exercise Training

Usual Care

NO INTERVENTION

Interventions

Aerobic Exercise TrainingBEHAVIORAL

The exercise group will perform supervised stationary cycle ergometer exercise 3 days/week for 12 weeks and be progressed from 15 to 45 minutes and 60% to 80% of their VO2 reserve over the course of the intervention.

Exercise

Eligibility Criteria

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

You may qualify if:

  • Non-hodgkin's lymphoma (including chronic lymphocytic leukemia) or Hodgkin's disease
  • Approval of the treating oncologist
  • Scheduled to receive no chemotherapy or chemotherapy for at least 8 weeks
  • Able to understand and provide written informed consent in English
  • + years of age
  • No uncontrolled hypertension, cardiac illness, psychiatric condition
  • No contraindication to exercise as determined by a fitness test

You may not qualify if:

  • Pregnant.
  • Transplant candidate.
  • Unwilling to accept randomization.
  • Any medical condition that would be a contraindication to exercise. The clinicians will make this decision.
  • Unwilling to travel to/participate in the exercise program as defined by the protocol.
  • Planned/known absence of greater than 2 weeks during the intended study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G2H9, Canada

Location

Related Publications (3)

  • Courneya KS, Forbes CC, Trinh L, Sellar CM, Friedenreich CM, Reiman T. Patient satisfaction with participation in a randomized exercise trial: effects of randomization and a usual care posttrial exercise program. Clin Trials. 2013;10(6):959-66. doi: 10.1177/1740774513495985. Epub 2013 Aug 5.

    PMID: 23918843DERIVED

  • Courneya KS, Sellar CM, Trinh L, Forbes CC, Stevinson C, McNeely ML, Peddle-McIntyre CJ, Friedenreich CM, Reiman T. A randomized trial of aerobic exercise and sleep quality in lymphoma patients receiving chemotherapy or no treatments. Cancer Epidemiol Biomarkers Prev. 2012 Jun;21(6):887-94. doi: 10.1158/1055-9965.EPI-12-0075. Epub 2012 Apr 20.

    PMID: 22523181DERIVED

  • Courneya KS, Stevinson C, McNeely ML, Sellar CM, Friedenreich CM, Peddle-McIntyre CJ, Chua N, Reiman T. Effects of supervised exercise on motivational outcomes and longer-term behavior. Med Sci Sports Exerc. 2012 Mar;44(3):542-9. doi: 10.1249/MSS.0b013e3182301e06.

    PMID: 21814149DERIVED

MeSH Terms

Conditions

LymphomaMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Kerry S Courneya, Ph.D.

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 26, 2005

First Posted

May 27, 2005

Study Start

April 1, 2005

Primary Completion

August 1, 2008

Study Completion

April 1, 2009

Last Updated

August 26, 2008

Record last verified: 2008-08

Locations

CA(1)