Exercise Intervention Study for Pancreatic Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-12-31

Brief Summary

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The purpose of this study is to compare the effects of two specific exercise interventions and one standard care control arm on physical functioning.The investigators expect that supervised training is most beneficial to the patients. However, they also expect some benefit for patients in the home-based training.

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Detailed Description

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The randomized-controlled balanced-parallel-group trial included 65 adult pancreatic cancer patients (stage I-IV) from the University Surgery Clinic in Heidelberg. The study compared two specific exercise interventions and one standard care control arm. The intervention programs were (1) a 6-month supervised moderate-to-high-intensity, progressive resistance training, and (2) a 6-month home-based exercise training. Thus, the two interventions differed primarily by the intensity and mode-of-administration of the intervention. Both interventions started at the earliest 8 weeks after surgery to allow for wound healing until Maximum 12 months after the surgery. The supervised progressive training started with only moderate-intensity training during the first 4 weeks. Only patients without comorbidities that preclude participation in the intervention arms (e.g. severe pain, heart insufficiency, reduced standing or walking ability) were eligible.

The primary objective is to compare the effects of the different interventions on physical functioning, measured as change from baseline to 6 months. Additional endpoints are overall quality of life, fatigue, endurance, and strength performance, adherence to the interventions, discontinuation of adjuvant therapy, body weight and composition, disease progression, overall and progression-free survival. All outcomes has been assessed every 3 months for a minimum follow-up period of 12 months.

Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Six months supervised exercise training

Group Type EXPERIMENTAL

Six months supervised resistance training

Intervention Type BEHAVIORAL

progressive resistance training (2x/week), starting at the earliest 8 weeks after surgery until maximum 12 months after the surgery with only low-to-moderate-intensity training during the first 4 weeks.

Six months home-based exercise training

Group Type EXPERIMENTAL

Six months home-based exercise training

Intervention Type BEHAVIORAL

Home-based exercise training (2x/week) with initial counseling and weekly telephone contact starting at the earliest 8 weeks after surgery until maximum 12 months after the surgery.

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Six months supervised resistance training

progressive resistance training (2x/week), starting at the earliest 8 weeks after surgery until maximum 12 months after the surgery with only low-to-moderate-intensity training during the first 4 weeks.

Intervention Type BEHAVIORAL

Six months home-based exercise training

Home-based exercise training (2x/week) with initial counseling and weekly telephone contact starting at the earliest 8 weeks after surgery until maximum 12 months after the surgery.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Pancreatic cancer patients (stage I-IV)
* Patients ≥ 18 years of age
* Resection performed at the University Clinic of Heidelberg
* Sufficient German language skills
* Signed informed consent

Exclusion Criteria

• Presence of comorbidities that preclude participation in the intervention arms (e.g. severe pain, heart insufficiency, reduced standing or walking ability)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No