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Individual home training for patients with head and neck tumors - a multi-centre study to improve the quality of life (HeiKo study) - OSHO #94

Individual home training for patients with head and neck tumors - a multi-centre study to improve the quality of life (HeiKo study) - OSHO #94 - OSHO #94

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00023883
Enrollment
53
Registered
2020-12-23
Start date
2021-01-02
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Head-neck Tumors

Interventions

Group 1: Questionnaire and functionality survey before and after completion of the intervention and three months follow-up.

Sponsors

Klinik III (Hämatologie, Onkologie, Palliativmedizin) Zentrum für Innere Medizin Universitätsmedizin Rostock
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Patients with tumours of mouth, jaw, face and neck (ICD: C00-C14, C30-C32) in follow-up (following antineoplastic therapy) or stable remission under immunotherapy - medical authorisation

Exclusion criteria

Exclusion criteria: Exclusion criteria: Patients who meet at least one of the following criteria are not included in this study: - non-consenting patients - not all inclusion criteria are met - clinically relevant heart failure (NYHA III and IV), - fresh myocardial infarction (< 4 weeks), - unstable angina pectoris, - higher-grade valve vitias (with a history), - uncontrolled cardiac arrhythmias, - chronic obstructive pulmonary disease, disease stage III or higher according to GOLD, - paVK from stage III to Fontaine - diseases that could seriously impair cognitive performance (e. g. dementia, stroke, Wernicke-Korsakoff syndrome) - < 24 points Mini-Mental State Examination (MMSE) - known alcohol dependence

Design outcomes

Primary

MeasureTime frame
Phase A - Feasibility (N=25, completed) Percentage of patients who perform the training intervention in a home-based setting over 12 weeks Phase B - Quality of life (N=53, recruiting) Change of the global QoL score (EORTC-QLQ-30) after a 12-week training intervention in the home-based setting

Secondary

MeasureTime frame
Secondary Outcomes: - Reasons for premature termination of the 12-week training intervention - Frequency and duration of training in the home based setting on average per week (training scope) - Medium term change in QoL after a 12-week training intervention in the home based setting - Short term change in mobility after a 12-week training intervention in the home based setting - Medium term change in mobility after a 12-week training intervention in the home based setting - Short term change in physical activity after a 12-week training intervention in the home based setting - Medium term change in physical activity after a 12-week training intervention in the home based setting - Short-term change in balance ability / gait safety after a 12-week training intervention in a home-based setting - Medium-term change in balance ability / gait safety after a 12-week training intervention in a home-based setting - Short-term change in aerobic endurance performance after a 12-week training intervention in a home-based setting - Medium-term change in aerobic endurance performance after a 12-week training intervention in a home-based setting - Short-term changes in body composition after a 12-week training intervention in a home-based setting - Medium-term changes in body composition after a 12-week training intervention in a home-based setting - Relationships between the amount of training during the 12-week training intervention and the effects in terms of QoL - correlations between the amount of training during the 12-week training intervention and the effects in terms of functionality - correlations between the amount of training during the 12-week training intervention and the effects in terms of body composition - correlations between everyday activity and QoL - correlations between everyday activity and functionality - correlations between everyday activity and body composition - differences in the perception of the subjective effec

Countries

Germany

Contacts

Public ContactSabine Felser

Universitätsmedizin Rostock Zentrum für Innere Medizin Klinik III (Hämatologie, Onkologie, Palliativmedizin)

sabine.felser@med.uni-rostock.de0381 494 7395

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026