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Exercise Intervention Study for Pancreatic Cancer Patients

SUPPORT - Study Supervised Progressive Resistance Training for Pancreatic Cancer Patients: a Randomized Controlled Intervention Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01977066
Acronym
SUPPORT
Enrollment
65
Registered
2013-11-06
Start date
2013-11-30
Completion date
2016-12-31
Last updated
2017-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

pancreatic cancer, exercise training, quality of life, physical functioning

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALSix 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.

BEHAVIORALSix 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.

Sponsors

University of Heidelberg Medical Center
CollaboratorOTHER
Deutsche Krebshilfe e.V., Bonn (Germany)
CollaboratorOTHER
German Cancer Research Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Physical functioning score, as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) EORTC QLQ-C30Change from baseline to end of intervention (after 6 months)

Secondary

MeasureTime frame
Overall quality of life from EORTC QLQ-C30 and the specific module for pancreatic cancer(QLQ-PAN26)change from Baseline to end of intervention (6 months)

Other

MeasureTime frame
Fatigue (Multidimensional Fatigue Inventory (MFI))change from baseline to end of intervention (6 months)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026