Effects of a Walking Program in People With Mental Disorders
Short- and Long-term Effects of a Walking Program ("Join the Walk?") on Physical Activity, Physical Fitness and Subjective Well-Being With Members of a Sports Federation for People With Mental Disorders (Psylos).
The purpose of this study is to investigate the short- and long-term effects of a 10-week walking program, based on the self-determination theory, in people with mental disorders. The investigators expect positive effects on:
- Physical fitness
- Physical activity
- Well-being (less feelings of anxiety, less feelings of depression) The investigators also expect underlying psychosocial processes to influence these effects.
調査の概要
詳細な説明
Framework: Previous research has shown beneficial health effects of a 10-week walking program in a senior organisation. Based upon the self-determination theory, similar results can be expected in people with mental disorders and could be highly relevant, given the fact that these people:
- Are often less active
- Have mental problems and often also comorbidities
- Are often socially isolated
Participants: Psylos tries to recruit a convenience sample of at least 100 participants for an intervention group (which will undertake the walking program) and 80 participants for a control group. All of them have to sign an informed consent. Due to attrition, at least 60 participants in the intervention group and 40 in the control group can be expected. A post hoc analysis, with detailed information about the variation in this population, may give additional information about the necessary power to obtain significant results.
Data analysis: First there will be examined whether the participants in both groups are equal at baseline according to relevant parameters (due to the non-randomisation). Second, to test the main effects, the difference scores will be examined between both groups. If certain assumptions are met, by an unpaired t-test; if not, by a non-parametric test. Finally (if relevant), the underlying psychosocial processes will be examined by regression analyses.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Vlaams-Brabant
-
Leuven、Vlaams-Brabant、ベルギー、3000
- KU Leuven
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- At least 18 years old
- Member of Psylos
- Medically approved by a physician
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Intervention group
Receives:
|
|
|
介入なし：Control group
Only receives measurements.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in physical fitness pre - post
時間枠：baseline, 10 weeks
|
Via 6 minute walk test.
|
baseline, 10 weeks
|
|
Change in physical fitness pre - follow-up
時間枠：baseline, 6 months
|
Via 6 minute walk test.
|
baseline, 6 months
|
|
Change in physical activity pre - post
時間枠：baseline, 10 weeks
|
Via a questionnaire.
|
baseline, 10 weeks
|
|
Change in physical activity pre - follow-up
時間枠：baseline, 6 months
|
Via a questionnaire.
|
baseline, 6 months
|
|
Change in well-being pre - post
時間枠：baseline, 10 weeks
|
Via a questionnaire.
|
baseline, 10 weeks
|
|
Change in well-being pre - follow-up
時間枠：baseline, 6 months
|
Via a questionnaire.
|
baseline, 6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in psychosocial parameters pre - post
時間枠：baseline, 10 weeks
|
Via a questionnaire.
|
baseline, 10 weeks
|
|
Change in psychosocial parameters pre - follow-up
時間枠：baseline, 6 months
|
Via a questionnaire.
|
baseline, 6 months
|
協力者と研究者
捜査官
- 主任研究者：Filip Boen, Prof.、KU Leuven
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- ML10148
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。