Comparison of home-based rehabilitation and a centre-based exercise in terms of functional capacity, muscle oxygenation and quality of life in people with peripheral arterial disease: a protocol for a randomised controlled trial
Introduction Peripheral arterial disease (PAD) is increasingly prevalent, and supervised physical exercise programmes are recommended as the first-line treatment. However, these programmes are underused. Alternative delivery models may be able to expand treatment coverage. The objective of this stud...
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2024-03-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/3/e080071.full |
| _version_ | 1826804417374978048 |
|---|---|
| author | Verônica Franco Parreira Isabella de Oliveira Nascimento Patrícia Paulino Geisel Valéria Cristina de Faria Ana Paula Ferreira Bruno Rezende Passos Déborah Prado Danielle Gomes Pereira |
| author_facet | Verônica Franco Parreira Isabella de Oliveira Nascimento Patrícia Paulino Geisel Valéria Cristina de Faria Ana Paula Ferreira Bruno Rezende Passos Déborah Prado Danielle Gomes Pereira |
| author_sort | Verônica Franco Parreira |
| collection | DOAJ |
| description | Introduction Peripheral arterial disease (PAD) is increasingly prevalent, and supervised physical exercise programmes are recommended as the first-line treatment. However, these programmes are underused. Alternative delivery models may be able to expand treatment coverage. The objective of this study was to compare a home-based exercise programme (HBEP) and a centre-based exercise (CBE) in terms of their effects on functional capacity, peripheral muscle oxygenation and quality of life in individuals with PAD.Methods and analysis This single-blind, parallel randomised clinical trial will consist of two groups: HBEP and CBE. A qualitative analysis will be carried out to investigate acceptability and satisfaction. The primary outcome will be functional capacity, assessed by the incremental shuttle walk test. Secondary outcomes will include functional capacity, assessed by a treadmill walking test; peripheral muscle oxygenation and quality of life; and self-reported functional impairment, risk factors, morbidity, level of physical activity, adherence, acceptability and satisfaction. The intervention protocols will consist of 12 weeks of intermittent walking until claudication symptoms, three times a week. Participants randomly assigned to the CBE group will participate in supervised face-to-face sessions. The HBEP group will perform exercises at home with remote supervision, monitored by a pedometer and heart rate monitor, and subjective perception of effort during each session will be recorded by participants in a training diary; follow-up will be conducted by telephone calls. Statistical analyses will follow the intention-to-treat principle. Participants allocated to the HBEP group will be interviewed about their experience of remote treatment using a qualitative approach.Ethics and dissemination Ethics approval was obtained from the Ethics Committee of the Universidade Federal de Minas Gerais. The results will be disseminated in a peer-reviewed journal and presented at international congresses. This research has the potential to improve the care of people with PAD because if home-based rehabilitation demonstrates effectiveness, it could be considered an alternative or support resource to the usual centre-based treatment models, expanding access, coverage and participation in vascular physiotherapyTrial registration https://ensaiosclinicos.gov.br/rg/RBR-97vy9n7 on 14 April 2022. |
| first_indexed | 2024-04-24T13:42:23Z |
| format | Article |
| id | doaj.art-f6e9b4fe914a4268816b0966479fde98 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2025-03-17T01:54:13Z |
| publishDate | 2024-03-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-f6e9b4fe914a4268816b0966479fde982025-02-15T04:45:10ZengBMJ Publishing GroupBMJ Open2044-60552024-03-0114310.1136/bmjopen-2023-080071Comparison of home-based rehabilitation and a centre-based exercise in terms of functional capacity, muscle oxygenation and quality of life in people with peripheral arterial disease: a protocol for a randomised controlled trialVerônica Franco Parreira0Isabella de Oliveira Nascimento1Patrícia Paulino Geisel2Valéria Cristina de Faria3Ana Paula Ferreira4Bruno Rezende Passos5Déborah Prado6Danielle Gomes Pereira7Rehabilitation Sciences Program, Universidade Federal de Minas Gerais, Belo Horizonte, BrazilRehabilitation Sciences Program, Universidade Federal de Minas Gerais, Belo Horizonte, BrazilRehabilitation Sciences Program, Universidade Federal de Minas Gerais, Belo Horizonte, BrazilMarinha do Brasil, Belo Horizonte, BrazilUniversidade Federal de Minas Gerais, Belo Horizonte, BrazilHospital das Clínicas da Universidade Federal de Minas Gerais, Belo Horizonte, BrazilHospital das Clínicas da Universidade Federal de Minas Gerais, Belo Horizonte, BrazilRehabilitation Sciences Program, Universidade Federal de Minas Gerais, Belo Horizonte, BrazilIntroduction Peripheral arterial disease (PAD) is increasingly prevalent, and supervised physical exercise programmes are recommended as the first-line treatment. However, these programmes are underused. Alternative delivery models may be able to expand treatment coverage. The objective of this study was to compare a home-based exercise programme (HBEP) and a centre-based exercise (CBE) in terms of their effects on functional capacity, peripheral muscle oxygenation and quality of life in individuals with PAD.Methods and analysis This single-blind, parallel randomised clinical trial will consist of two groups: HBEP and CBE. A qualitative analysis will be carried out to investigate acceptability and satisfaction. The primary outcome will be functional capacity, assessed by the incremental shuttle walk test. Secondary outcomes will include functional capacity, assessed by a treadmill walking test; peripheral muscle oxygenation and quality of life; and self-reported functional impairment, risk factors, morbidity, level of physical activity, adherence, acceptability and satisfaction. The intervention protocols will consist of 12 weeks of intermittent walking until claudication symptoms, three times a week. Participants randomly assigned to the CBE group will participate in supervised face-to-face sessions. The HBEP group will perform exercises at home with remote supervision, monitored by a pedometer and heart rate monitor, and subjective perception of effort during each session will be recorded by participants in a training diary; follow-up will be conducted by telephone calls. Statistical analyses will follow the intention-to-treat principle. Participants allocated to the HBEP group will be interviewed about their experience of remote treatment using a qualitative approach.Ethics and dissemination Ethics approval was obtained from the Ethics Committee of the Universidade Federal de Minas Gerais. The results will be disseminated in a peer-reviewed journal and presented at international congresses. This research has the potential to improve the care of people with PAD because if home-based rehabilitation demonstrates effectiveness, it could be considered an alternative or support resource to the usual centre-based treatment models, expanding access, coverage and participation in vascular physiotherapyTrial registration https://ensaiosclinicos.gov.br/rg/RBR-97vy9n7 on 14 April 2022.https://bmjopen.bmj.com/content/14/3/e080071.full |
| spellingShingle | Verônica Franco Parreira Isabella de Oliveira Nascimento Patrícia Paulino Geisel Valéria Cristina de Faria Ana Paula Ferreira Bruno Rezende Passos Déborah Prado Danielle Gomes Pereira Comparison of home-based rehabilitation and a centre-based exercise in terms of functional capacity, muscle oxygenation and quality of life in people with peripheral arterial disease: a protocol for a randomised controlled trial BMJ Open |
| title | Comparison of home-based rehabilitation and a centre-based exercise in terms of functional capacity, muscle oxygenation and quality of life in people with peripheral arterial disease: a protocol for a randomised controlled trial |
| title_full | Comparison of home-based rehabilitation and a centre-based exercise in terms of functional capacity, muscle oxygenation and quality of life in people with peripheral arterial disease: a protocol for a randomised controlled trial |
| title_fullStr | Comparison of home-based rehabilitation and a centre-based exercise in terms of functional capacity, muscle oxygenation and quality of life in people with peripheral arterial disease: a protocol for a randomised controlled trial |
| title_full_unstemmed | Comparison of home-based rehabilitation and a centre-based exercise in terms of functional capacity, muscle oxygenation and quality of life in people with peripheral arterial disease: a protocol for a randomised controlled trial |
| title_short | Comparison of home-based rehabilitation and a centre-based exercise in terms of functional capacity, muscle oxygenation and quality of life in people with peripheral arterial disease: a protocol for a randomised controlled trial |
| title_sort | comparison of home based rehabilitation and a centre based exercise in terms of functional capacity muscle oxygenation and quality of life in people with peripheral arterial disease a protocol for a randomised controlled trial |
| url | https://bmjopen.bmj.com/content/14/3/e080071.full |
| work_keys_str_mv | AT veronicafrancoparreira comparisonofhomebasedrehabilitationandacentrebasedexerciseintermsoffunctionalcapacitymuscleoxygenationandqualityoflifeinpeoplewithperipheralarterialdiseaseaprotocolforarandomisedcontrolledtrial AT isabelladeoliveiranascimento comparisonofhomebasedrehabilitationandacentrebasedexerciseintermsoffunctionalcapacitymuscleoxygenationandqualityoflifeinpeoplewithperipheralarterialdiseaseaprotocolforarandomisedcontrolledtrial AT patriciapaulinogeisel comparisonofhomebasedrehabilitationandacentrebasedexerciseintermsoffunctionalcapacitymuscleoxygenationandqualityoflifeinpeoplewithperipheralarterialdiseaseaprotocolforarandomisedcontrolledtrial AT valeriacristinadefaria comparisonofhomebasedrehabilitationandacentrebasedexerciseintermsoffunctionalcapacitymuscleoxygenationandqualityoflifeinpeoplewithperipheralarterialdiseaseaprotocolforarandomisedcontrolledtrial AT anapaulaferreira comparisonofhomebasedrehabilitationandacentrebasedexerciseintermsoffunctionalcapacitymuscleoxygenationandqualityoflifeinpeoplewithperipheralarterialdiseaseaprotocolforarandomisedcontrolledtrial AT brunorezendepassos comparisonofhomebasedrehabilitationandacentrebasedexerciseintermsoffunctionalcapacitymuscleoxygenationandqualityoflifeinpeoplewithperipheralarterialdiseaseaprotocolforarandomisedcontrolledtrial AT deborahprado comparisonofhomebasedrehabilitationandacentrebasedexerciseintermsoffunctionalcapacitymuscleoxygenationandqualityoflifeinpeoplewithperipheralarterialdiseaseaprotocolforarandomisedcontrolledtrial AT daniellegomespereira comparisonofhomebasedrehabilitationandacentrebasedexerciseintermsoffunctionalcapacitymuscleoxygenationandqualityoflifeinpeoplewithperipheralarterialdiseaseaprotocolforarandomisedcontrolledtrial |