Rehabilitation - Physical Activity and Coping

Cancer Survivors Clinical Trial

— RPAC  

Official title:

Rehabilitation - Physical Activity and Coping

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04245943
• Other study ID #: 2019/620
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 22, 2019
• Est. completion date: October 31, 2024

Study information

• Verified date: February 2024
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The project is a non-randomized intervention study with group-based physical exercise. Cancer survivors who have participated in the rehabilitation program at the Center for Education and Rehabilitation are included in the study.

The cancer and cancer treatment have led to patients struggling with physical, mental and social late effects which prevent them from functioning in everyday life and return to work. The purpose of the project is to investigate whether one municipal group training measure can help to lower the threshold for the user to maintain good exercise habits and return to work / everyday life, as well as the effect on the user's physical form and quality of life and the transition between health level and the body itself measure.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: October 31, 2024
• Est. primary completion date: August 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years

• Women and men

• Regardless of cancer diagnosis

• Resident in Bergen municipality

• Finishes their rehabilitation at The Cancer Center for Education and Rehabilitation spring/summer 2019.

Exclusion Criteria:

• Patients who do not speak or understand Norwegian

• Unable to express themselves in writing

• Unable to perform basic daily tasks

• Display cognitive disorder or severe emotional instability

• Suffer from other debilitating illnesses / conditions that may inhibit physical exercise (heart failure, chronic obstructive pulmonary disease, orthopedic conditions, neurological disorders or the like) will be excluded from the study. -

Related Conditions & MeSH terms

• Cancer Survivors

Intervention

Behavioral:
• Exercise training
18 weeks supervised strength and aerobic exercise training.

Locations

Country	Name	City	State
Norway	Helse Bergen,	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objectively recorded physical activity level	Change in objectively recorded physical activity level, measured with the SenseWear ™ Mini Armband (SWA) (BodyMedia Inc. Pittsburgh, PA, USA) as average minutes of moderate- to vigorous intensity physical activity (MVPA) from before intervention to after completion of the intervention.	18 weeks
Secondary	Change in maximal oxygen uptake measured by VO2max	Change in VO2max, measured by a maximal incremental exercise test on a treadmill, from before training intervention to post training intervention.	18 weeks
Secondary	Change in maximal strength	Change in 1 repetition maximum strength in upper and lower body measured from before intervention and after completion of the intervention.	18 weeks
Secondary	Change in quality of life measured by Short Form Health Survey (SF-36)	Change in scores on the Short Form Health Survey (SF-36) from before intervention to after completion of the intervention.	18 weeks
Secondary	Change in fatigue scores using the Chalder Fatigue Questionaire (FQ)	Change in scores on the Chalder Fatigue Questionaire (FQ) from before intervention to after completion of the intervention.	18 weeks