NCT02221986

Brief Summary

The results of the present RCT study will add to the growing body of literature investigating the potential role of exercise as a supportive therapeutic intervention for patient with glioma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

August 19, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2018

Completed
Last Updated

April 5, 2018

Status Verified

September 1, 2017

Enrollment Period

3 years

First QC Date

August 19, 2014

Last Update Submit

April 3, 2018

Conditions

NeoplasmsCNS Neoplasms

Keywords

Interdisciplinary rehabilitationNeurooncologyPhysiotherapyOccupational therapyNeurorehabilitationGlioma

Outcome Measures

Primary Outcomes (1)

  • Health related quality of life

    Questionnaires EORTC-QLQ-30 \& BN-20

    Change from Baseline HRQoL at 6 months

Secondary Outcomes (7)

  • Symptom burden

    Change from Baseline Symptom burden at 6 months

  • Physical activity levels

    Change from Baseline Physical activity levels at 6 months

  • Muscle strength

    Change from Baseline Musclestrength at 3 months

  • VO2peak

    Change from Baseline VO2peak at 3 months

  • Balance

    Change from Baseline Balance at 3 months

  • +2 more secondary outcomes

Study Arms (2)

Interdisciplinary rehabilitation

EXPERIMENTAL

The intervention consists of 6 weeks intensive outpatient physiotherapy in conjunction with 0-6 weeks of occupational therapy if need is indicated. The physical intervention contains supervised group exercise of 90 minutes three times a week in groups up to four patients included continuously. The occupational therapy intervention consists of individual training 60 minutes twice a week for patients having deficits in activity or participation levels measured by the Assessment of Motor and Process Skills (AMPS).

Behavioral: Interdisciplinary rehabilitation

Care as usual

NO INTERVENTION

The control group receives usual standard of care (e.g. no training, individual training or group training in the municipality). The amount of training in this group is based on a questionnaire at the follow-up trials.

Interventions

Interdisciplinary rehabilitationBEHAVIORAL
Interdisciplinary rehabilitation

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of primary glioma (WHO grades I-IV)
  • Age ≥ 18
  • Reference with diagnosis or treatment at Odense University Hospital
  • Karnofsky performance score (KPS) ≥70
  • Ability to understand Danish.

You may not qualify if:

  • Pregnancy
  • Known psychiatric diagnosis or substance abuse
  • Heart problems excluding intense exercise (NYHA group III and IV)
  • Pronounced impressive/expressive aphasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, Funen, 5000, Denmark

Location

Related Publications (3)

  • Hansen A, Pedersen CB, Jarden JO, Beier D, Minet LR, Sogaard K. Effectiveness of Physical Therapy- and Occupational Therapy-Based Rehabilitation in People Who Have Glioma and Are Undergoing Active Anticancer Treatment: Single-Blind, Randomized Controlled Trial. Phys Ther. 2020 Mar 10;100(3):564-574. doi: 10.1093/ptj/pzz180.

    PMID: 32043148DERIVED

  • Fahrenholtz ML, Hansen A, Sogaard K, Andersen LN. Finding 'the inner drive' for a rehabilitation process: a small-scale qualitative investigation among male patients with primary glioma. BMJ Open. 2019 Dec 8;9(12):e031665. doi: 10.1136/bmjopen-2019-031665.

    PMID: 31818840DERIVED

  • Hansen A, Rosenbek Minet LK, Sogaard K, Jarden JO. The effect of an interdisciplinary rehabilitation intervention comparing HRQoL, symptom burden and physical function among patients with primary glioma: an RCT study protocol. BMJ Open. 2014 Oct 3;4(10):e005490. doi: 10.1136/bmjopen-2014-005490.

    PMID: 25280804DERIVED

MeSH Terms

Conditions

NeoplasmsCentral Nervous System NeoplasmsGlioma

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNervous System DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Karen Søgaard, Professor

    University of Southern Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist, Master of Health Science

Study Record Dates

First Submitted

August 19, 2014

First Posted

August 21, 2014

Study Start

February 1, 2015

Primary Completion

February 14, 2018

Study Completion

February 14, 2018

Last Updated

April 5, 2018

Record last verified: 2017-09

Locations

DK(1)