Rehabilitation - Physical Activity and Coping

NCT04245943 | Active Not Recruiting

• 1 other identifier: 2019/620
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer Survivors

Keywords

Rehabilitation; Physical exercise; Return to work; Fatigue; Cancer survivors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in maximal oxygen uptake measured by VO2max

  18 weeks

• Change in maximal strength

  18 weeks

• Change in quality of life measured by Short Form Health Survey (SF-36)

  18 weeks

• Change in fatigue scores using the Chalder Fatigue Questionaire (FQ)

  18 weeks

Study Arms (1)

Exercise

EXPERIMENTAL

18 weeks supervised strength and aerobic exercise training

Behavioral: Exercise training

Interventions

Exercise training BEHAVIORAL

18 weeks supervised strength and aerobic exercise training.

Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Helse Bergen,

Bergen, 5021, Norway

Location

MeSH Terms

Conditions

Motor Activity; Fatigue

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Cecilia Arving, PhD

  Helse Bergen, Cancer Center for Education and Rehabilitation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 29, 2020
• Study Start: July 22, 2019
• Primary Completion: August 26, 2019
• Study Completion: October 31, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available from February 2020 to October 31. 2024

Locations

NO (1)