Hiking and Coaching (HICO): Lifestyle change for prevention of diseases
| ISRCTN | ISRCTN25562081 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25562081 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 415-E/1488/2-2012 |
| Sponsor | Paracelsus Medical University |
| Funders | European Regional Development Fund, Participating hotel companies in Pinzgau |
- Submission date
- 14/05/2020
- Registration date
- 18/11/2020
- Last edited
- 03/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
The HICO-Study aims to investigate whether a physically active stay (mountain hiking) in the Alpine region with or without psychological coaching has a lasting impact on cardiorespiratory fitness, lifestyle, physiological and psychological stress, quality of life and clinical measurements of metabolism.
Who can participate?
The study includes subjects between the ages of 22 and 54 who have a sedentary lifestyle.
What does the study involve?
The study is carried out as part of a 7-day vacation in 4 regions in Salzburg Land.
Participants are randomly allocated to one of three groups. The participants in groups 1 and 2 complete a structured exercise program of mountain hiking from Sunday to Friday (no hiking on Wednesdays) with a daily height difference of at least 600 meters. The participants in group 1 additionally receive 3 individual psychological coaching units during the exercise program week and one at the follow-up visit around 80 days after the vacation. The participants in the third group have no exercise program or coaching.
All three groups are given the same questionnaires and examinations are collected over the study period. All medical examinations are performed by members of Institute of Ecomedicine respectively of the Institut für Physiologie und Pathopysiologie from the Paracelsus Medical University of Salzburg.
What are the possible benefits and risks of participating?
All study participants receive a 7-day holiday. A vacation often improves mood and quality of life. The findings from the study may be that taking part in an exercise program and psychological coaching can cause an increase in cardiorespiratory fitness and quality of life and that these effects are sustainable. As a negative side effect of physical activity, exercise-induced muscular discomfort may occur.
Where is the study run from?
The Paracelsus Medical University of Salzburg (Austria)
When is the study starting and how long is it expected to run for?
From January 2012 to February 2013
Who is funding the study?
The European Fund for Regional Development (EU) and the participating hotel companies in Pinzgau.
Who is the main contact?
Dr. Arnulf Hartl
arnulf.hartl@pmu.ac.at
Contact information
Scientific
Paracelsus Medical University Salzburg
Institute of Ecomedicine
Univ. Doz. Dr. Arnulf Hartl
Strubergasse 22
Salzburg
5020
Austria
 ORCID ID |
0000-0001-9626-6425 |
|---|---|
| Phone | +43 (0)662 2420 80530 |
| arnulf.hartl@pmu.ac.at |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Three-arm randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The HICO study: Sustainability of a multimodal intervention on health awareness and quality of life of 30-50 year old healthy adults with special attention to exercise. A randomized controlled trial |
| Study acronym | HICO |
| Study objectives | 1. Mountain hiking +/- psychological coaching has a lasting positive influence on the cardiorespiratory fitness of healthy subjects with a sedentary lifestyle 2. Improvement in quality of life, psychological health and quality of the relationships of couples, reduction of stress, and positive effect of coaching |
| Ethics approval(s) | Approved 04/05/2012, the Ethics Committee for the State of Salzburg (Stefan-Stief-Gasse 2, Postfach 527, 5010 Salzburg Austria; ethikkommission@salzburg.gv.at; +43 662 8042 0), ref: 415-E/1488/2-2012 |
| Health condition(s) or problem(s) studied | Sedentary lifestyle |
| Intervention | Participants are invited as couples and are allocated to the same intervention group, they will then be treated as a single participant. Participants are randomized into one of three intervention groups: 1. 1st arm is an intervention group which involves mountain hiking and psychological coaching 2. 2nd arm is an intervention group which involves mountain hiking 3. 3rd arm is the control group who receive no treatment Randomization is carried out using the "Random Allocation Software" program with a block randomization protocol (Saghaei 2004). Due to a shortage of suitable patients, only the hiking and the coaching groups are randomized. The study is carried out as part of a 7-day vacation in 4 different regions in Salzburg Land. All subjects in both intervention groups complete a structured exercise program of mountain hiking with a daily height difference of at least 600 m. The subjects in the coaching group also receive 3 individual psychological coaching units during the intervention week and one at the follow-up visit. The follow-up visit occurs at approximately 80 days after the first intervention. In the control group without treatment, the same questionnaires and examinations are collected over the same period. All medical examinations are performed by members of the Institute of Ecomedicine respectively of the Institut für Physiologie und Pathopysiologie from the Paracelsus Medical University of Salzburg. |
| Intervention type | Mixed |
| Primary outcome measure(s) |
Cardiorespiratory fitness is measured by Rockport-Test and Spirometry at baseline, 7 and 80 days |
| Key secondary outcome measure(s) |
1. Quality of Life measured using the European Quality of Life-5 Dimensions (EQ-5D) survey, 36-Item Short Form Survey (SF-36) and Visual Analogue Scale (VAS) at baseline, 7 and 80 days |
| Completion date | 01/02/2013 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 90 |
| Total final enrolment | 90 |
| Key inclusion criteria | Couples where both partners meet the criteria: 1. Aged 22 to 54 years 2. Sedentary lifestyle, defined as a score of ≤1.6 on the questionnaire from Johansson and Westerterp (2008) |
| Key exclusion criteria | 1. Malignant neoplastic diseases 2. Cardiovascular diseases and severe hypertension level 3 3. Orthopedic diseases 4. Acute pain 5. Pulmonary dysfunction 6. Uncontrolled metabolic diseases e.g. diabetes mellitus 7. Active infectious diseases 8. Pregnancy 9. Taking antihypertensive medication |
| Date of first enrolment | 07/05/2012 |
| Date of final enrolment | 15/10/2012 |
Locations
Countries of recruitment
- Austria
Study participating centre
Strubergasse 21
Salzburg
5020
Austria
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Arnulf Hartl, Paracelsus Medical University Salzburg, Institute of Ecomedicine, Strubergasse 22, 5020 Salzburg, Austria |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 24/03/2022 | 03/01/2023 | Yes | No | |
| Basic results | 03/06/2020 | 18/11/2020 | No | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN25562081_BasicResults_03Jun2020.pdf
- uploaded 18/11/2020
Editorial Notes
03/01/2023: Publication reference added.
18/11/2020: The basic results of this trial have been uploaded as an additional file.
28/05/2020: Trial’s existence confirmed by the Ethics Committee for the State of Salzburg.
