NCT02677129

Brief Summary

The study is a randomized controlled trial with the aim to examine the feasibility and the effects of a home-based exercise intervention program on activities of daily living (ADL) in patients with advanced gastrointestinal cancer undergoing chemotherapeutic treatment. Further outcomes include functional and body status, quality of life, body composition, and chemotherapy completion rate. Study participants will be randomized to an exercise intervention group or a wait-list control group

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

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

Study Start

First participant enrolled

August 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

April 12, 2017

Status Verified

April 1, 2017

Enrollment Period

2.1 years

First QC Date

February 2, 2016

Last Update Submit

April 11, 2017

Conditions

Advanced Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (1)

  • Short Physical Performance Battery

    Short battery of physical performance tests used to assess lower extremity function. Balance, gait, strength, and endurance are evaluated.

    Change between the first 12 weeks of chemotherapy

Secondary Outcomes (16)

  • Daily physical activity

    3 times in the course of 12 weeks of chemotherapy

  • Polyneuropathy

    3 times in the course of 12 weeks of chemotherapy

  • Gait speed

    3 times in the course of 12 weeks of chemotherapy

  • Postural sway

    3 times in the course of 12 weeks of chemotherapy

  • Maximum isometric voluntary force of the upper extremity

    3 times in the course of 12 weeks of chemotherapy

  • +11 more secondary outcomes

Study Arms (2)

home-based exercise intervention

EXPERIMENTAL

home-based exercise intervention: Endurance training (moderate intensity; walking), 3-5 times per week Patients will receive exercise counselling how to realize the planned intervention home-based. Further, they will be asked to fill out an exercise log. The study team will periodically review adherence to the intervention and identify problems.

Other: home-based exercise intervention

Waiting control group

NO INTERVENTION

The wait list control group receives usual care over the study period. Usual care depends on the hospital guidelines as well as oncologists' and physicians' consideration.

Interventions

home-based exercise interventionOTHER

Endurance training (moderate intensity; walking), 3-5 times per week Patients will receive exercise counselling how to realize the planned intervention home-based. Further, they will be asked to fill out an exercise log. The study team will periodically review adherence to the intervention and identify problems.

home-based exercise intervention

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically classified gastrointestinal cancer
  • UICC III-IV
  • Prior to (planned) first-line chemotherapy (curative und palliative)
  • ≥50 years

You may not qualify if:

  • ECOG \> 2
  • Systemic diseases (MS, ALS)
  • disorders (neurological, skeletal, muscular, mental or cognitive) or drug use (irrespective of the cancer therapy) that may affect gait, balance or muscular strength
  • chronic infection, uncontrolled hypertension (diastolic pressure over 95 mmHg)
  • vestibulopathies
  • uncorrected visual deficits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Agaplesion Markus Hospital

Frankfurt, 60487, Germany

Location

Study Officials

  • Winfried Banzer, Prof.

    Department of Sports Medicine, Goethe University Frankfurt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department

Study Record Dates

First Submitted

February 2, 2016

First Posted

February 9, 2016

Study Start

August 1, 2014

Primary Completion

September 1, 2016

Study Completion

November 1, 2016

Last Updated

April 12, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Only pseudonymised data without the plan to share

Locations

DE(1)