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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04245943
Other study ID # 2019/620
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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. -

Study Design


Related Conditions & MeSH terms


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
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