The Roles of Peers and Functional Tasks in Enhancing Exercise Training for Adults With COPD
7. Februar 2022 aktualisiert von: Shane Norman Sweet, McGill University
The Roles of Peers and Functional Tasks in Enhancing Exercise Training for Adults With COPD: a Pilot Randomized Controlled Trial
This study aims to evaluate the effects of an online exercise and peer support intervention for people living with COPD.
In the framework of a randomized control trial, 24 adults with COPD will be recruited to participate in the study and will be randomly assigned to either the control or intervention group.
The control group will participate in an 8-week virtual program based on the exercise component of a standard home-based pulmonary rehabilitation program (one online consultation and 7 phone calls with a kinesiologist).
The intervention group will participate in a twice a week online intervention that includes an exercise component based on individuals' activities of daily living and a peer support component where individuals will be taught and encouraged to discuss behaviour change techniques that have been shown to help support increased participation in physical activity and/or exercise.
The goal of this study is to determine the efficacy of the novel online exercise intervention and whether the benefits are above other intervention options.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Studientyp
Interventionell
Einschreibung (Tatsächlich)
22
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Quebec
-
Montreal, Quebec, Kanada, H3A 0G4
- McGill University
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Individuals must be at least 18 years of age, have no diagnosed cognitive impairment, have a COPD diagnosis, be medically able to participate in exercise (confirmed by healthcare professional in the past 2 years), have access to a computer with a camera and internet, speak English or French, and have the intention to become physically active in the next 2 months or have been minimally active (<150 minutes per week) in the past 2 months
Exclusion Criteria:
- less than 18 years of age, diagnosed with a cognitive impairment, not diagnosed with COPD by a medical professional, unable to participate in exercise or unconfirmed in the past 2 years from a medical professional, no access to a computer and internet.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Intervention Group
Those randomized to the intervention group will be asked to attend 16 online sessions (2 session/week).
Each session will last one hour (total time: 16 hours.
The exercise portion will be approximately 30 minutes of each session and led by a certified kinesiologist.
These exercises are based on activities related to your daily life.
As well, they will take part in peer support sessions.
The peer support session will be approximately 30 minutes and be moderated by a behaviour change specialist who will also provide strategies to be active.
In this peer support group, particpants will share and learn from other individuals living with COPD to help you stay active during and after the intervention.
The online sessions will be video recorded to make sure that the program is delivered as designed.
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An 8 week two-arm pilot randomized control trial aimed to evaluate the effects of an online exercise and peer support intervention for people living with COPD.
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Aktiver Komparator: Control Group
Those randomized to the control group will be asked to participate in an 8-week exercise program based on the exercise component of a standard home-based pulmonary rehabilitation program.
During week 1 of the program, participants will receive a videocall via Microsoft Teams from the certified kinesiologist who will prescribe an exercise program, supervise the first exercise session, and provide a copy of Living Well with COPD, a list of strength exercises, and a home exercise diary.
In weeks 2-8, participant exercises will be performed offline, on their own.
Participants will be encouraged to engage in two or more exercise sessions per week, targeting both aerobic capacity and muscular strength, and document their exercise using a home diary.
They will also receive a phone call once a week from the certified kinesiologist to discuss their exercise progress.
|
An 8 week two-arm pilot randomized control trial aimed to evaluate the effects of an online exercise and peer support intervention for people living with COPD.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Performance in activities of daily and social living
Zeitfenster: Baseline, 8 and 12 weeks
|
Participant goal participation will be measured by improvement in initial goals set at the beginning of the study using the Canadian Occupation Performance Measures (COPM).
Success will be determined by calculating individuals change score on their satisfaction with their performance in their target areas post-intervention.
A change score of 2 on an item is said to represent significant change (Law et al., 2000).
A change score of at least 2 on 50% of items (dependent on personal goals) for 70% of participants will be the indicator of success.
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Baseline, 8 and 12 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Timed "Up & Go" test
Zeitfenster: Baseline, 8 and 12 weeks
|
This test measures the time it takes an individual to stand from a standard chair (approximately 46cm), walk 3 metres, walk back, and return to sit on the chair (Podsiadlo & Richardson, 1991).
The participant is timed from when the leave the seat to when they are seated again.
A time of >30 seconds is the cut-off for safe unsupervised participation (Podsiadlo & Richardson, 1991).
Anyone who gets a time >30seconds will be informed that they cannot participate.
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Baseline, 8 and 12 weeks
|
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1-minute sit-to-stand test
Zeitfenster: Baseline, 8 and 12 weeks
|
The 1-minute sit-to-stand test is a measure of exercise capacity that has been validated with individuals living with COPD (Puhan et al., 2013).
Individuals sit on a standard chair without arm rests, with their legs hip-width apart and about 90 degrees knee flexion and aligned and are asked to hold their hands stationary on their hips.
Participants are then asked to stand and sit 1-2 times to familiar themselves with the movement.
Then, for the duration of 1 minute, participants are asked to do as many repetitions as possible of the sit to stand, without using arms for support.
The number of repetitions is recorded.
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Baseline, 8 and 12 weeks
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Handgrip Test
Zeitfenster: Baseline, 8 and 12 weeks
|
To measure handgrip strength, we will use a Hand Dynamometer that will be sent to participants.
Individuals sit with their shoulders adducted, elbows flexed to 90˚ and forearms in a neutral position (Puhan et al., 2013).
They are then asked to squeeze the handle as much as possible and read to the nearest kilogram where the needle stopped, which is then recorded.
The best of six measurements is used as an indication of upper body strength.
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Baseline, 8 and 12 weeks
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Borg Scale - Dyspnea
Zeitfenster: Baseline, 8 and 12 weeks
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On a scale from 0-10, participants' indicate their breathlessness level.
0- No breathlessness at all to 10- Maximal breathlessness
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Baseline, 8 and 12 weeks
|
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Godin Leisure Time Physical Activity Questionnaire
Zeitfenster: Baseline, 8, and 12 weeks
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Self-reported physical activity levels measured in length of bouts over the previous 7 days to determine physical activity frequency.
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Baseline, 8, and 12 weeks
|
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The Psychological Need Satisfaction in Exercise scale
Zeitfenster: Baseline, 8, and 12 weeks
|
This 1-6 scale represents different feelings people have when they exercise.
1-true to how they typically feel when exercising, and 6-false to how they typically feel when exercising.
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Baseline, 8, and 12 weeks
|
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The Treatment Self-Regulation Questionnaire
Zeitfenster: Baseline, 8, and 12 weeks
|
This 7 point scale relates to the reasons why one would either start to exercise regularly or continue to do so.
1- not at all true to the reason why they would exercise regularly, and 7- Very to true to the reason why they would exercise regularly.
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Baseline, 8, and 12 weeks
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Social Support from Peer Support Group Questionnaire
Zeitfenster: 8 and 12 weeks
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This 4 point scale measures how often during the past 4 weeks peers (i.e.
other people with COPD) have provided informational and emotional support to the participant.
1- Never provided the support described and 4- Very often provided the support described.
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8 and 12 weeks
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Medical Research Council Questionnaire on Breathlessness (mMRC)
Zeitfenster: Baseline, 8, and 12 weeks
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This questionnaire was used to measure participants' breathlessness burden using a single item scale from 0 to 4, where a score of 0-1 indicated mild breathlessness and 2-4 indicated increased breathlessness.
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Baseline, 8, and 12 weeks
|
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COPD Assessment Test (CAT)
Zeitfenster: Baseline, 8, and 12 weeks
|
This questionnaire was used to measure the impact COPD is having on well being and daily life.
The CAT is an eight-item semantic differential scale from 0 to 5, where 0 is no impact and 5 is extremely impactful.
Participants' scores were totaled and a score of ≥ 10 indicated higher than normal burden of disease.
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Baseline, 8, and 12 weeks
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Activities, Healthcare, and Research Priorities Survey
Zeitfenster: Baseline, 8, and 12 weeks
|
Participants will answer 26 questions based on daily and social activities and be asked if they participate in said activity.
Responses include: Yes - as much as I want.
Yes - but less than I want.
No - but I would like to do it.
No - and I don't want to do it.
|
Baseline, 8, and 12 weeks
|
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Three Factor Social Identity Questionnaire
Zeitfenster: 8, and 12 weeks
|
This 7 point scale measures feelings about being a part of the exercise and peer support group.
1-strongly disagree and 7- strongly agree to indicate agreement with each of the statements.
|
8, and 12 weeks
|
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The Acceptability of Intervention Measure (AIM)
Zeitfenster: 8, and 12 weeks
|
The Acceptability of Intervention Measure will be administered to measure high acceptability and satisfaction with the intervention.
Using a 5 point scale, participants will answer 8 questions and rate them as 1- Completely disagree to 5- Completely agree.
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8, and 12 weeks
|
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Intervention Appropriateness Measure (IAM)
Zeitfenster: 8, and 12 weeks
|
The Intervention Appropriateness Measure will be administered to measure high acceptability and satisfaction with the intervention.
Using a 5 point scale, participants will answer 8 questions and rate them as 1- Completely disagree to 5- Completely agree.
|
8, and 12 weeks
|
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Feasibility of Intervention Measure (FIM)
Zeitfenster: 8, and 12 weeks
|
The Feasibility of Intervention Measure will be administered to measure high acceptability and satisfaction with the intervention.
Using a 5 point scale, participants will answer 8 questions and rate them as 1- Completely disagree to 5- Completely agree.
|
8, and 12 weeks
|
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6-Item Health Care Climate Questionnaire
Zeitfenster: 4, 8, and 12 weeks
|
This 7 point scale measures how strongly the participant experienced interest, intrigue, focus, enjoyment, and annoyance during their participation in he Functional Tasks and Peer Support Intervention.
1-not at all experienced during the intervention to 7-extremely experienced during the intervention.
|
4, 8, and 12 weeks
|
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Behaviour Change Technique Usage Questionnaire
Zeitfenster: baseline, 8, and 12 weeks
|
Participants completed a questionnaire that asked them to rate on a scale from 1 (not once) to 5 (daily) how frequently they have used goal setting, action planning, coping planning, physical restructuring, self monitoring, values identification, social restructuring, resource finding, and self belief in the past two weeks,
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baseline, 8, and 12 weeks
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Shane Sweet, Ph.D, McGill University
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
9. September 2021
Primärer Abschluss (Tatsächlich)
31. Januar 2022
Studienabschluss (Tatsächlich)
31. Januar 2022
Studienanmeldedaten
Zuerst eingereicht
27. August 2021
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
12. September 2021
Zuerst gepostet (Tatsächlich)
14. September 2021
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
24. Februar 2022
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
7. Februar 2022
Zuletzt verifiziert
1. Februar 2022
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 250965
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