The Roles of Peers and Functional Tasks in Enhancing Exercise Training for Adults With COPD
7 februari 2022 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Interventionell
Inskrivning (Faktisk)
22
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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Quebec
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Montreal, Quebec, Kanada, H3A 0G4
- McGill University
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Aktiv 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Performance in activities of daily and social living
Tidsram: 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
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Timed "Up & Go" test
Tidsram: 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
Tidsram: 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
Tidsram: Baseline, 8 and 12 weeks
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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
Tidsram: Baseline, 8 and 12 weeks
|
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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: Baseline, 8, and 12 weeks
|
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)
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Activities, Healthcare, and Research Priorities Survey
Tidsram: Baseline, 8, and 12 weeks
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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.
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Baseline, 8, and 12 weeks
|
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Three Factor Social Identity Questionnaire
Tidsram: 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.
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8, and 12 weeks
|
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The Acceptability of Intervention Measure (AIM)
Tidsram: 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)
Tidsram: 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.
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8, and 12 weeks
|
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Feasibility of Intervention Measure (FIM)
Tidsram: 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.
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8, and 12 weeks
|
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6-Item Health Care Climate Questionnaire
Tidsram: 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.
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4, 8, and 12 weeks
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Behaviour Change Technique Usage Questionnaire
Tidsram: baseline, 8, and 12 weeks
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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
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Shane Sweet, Ph.D, McGill University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
9 september 2021
Primärt slutförande (Faktisk)
31 januari 2022
Avslutad studie (Faktisk)
31 januari 2022
Studieregistreringsdatum
Först inskickad
27 augusti 2021
Först inskickad som uppfyllde QC-kriterierna
12 september 2021
Första postat (Faktisk)
14 september 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 februari 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 februari 2022
Senast verifierad
1 februari 2022
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 250965
Plan för individuella deltagardata (IPD)
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