- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03748797
Effects of Supervised Exercise on Physical Health and Quality of Life Among Older HIV Adults
Effects of Supervised Exercise Program on Physical Health and Quality of Life Among Older Adults Living With HIV in Hong Kong
The effects of exercise for older HIV-infected adults have not been well studied, especially in Chinese population. This study aimed to investigate the effect of supervised exercise on physical health and quality of life among older people living with HIV (PLWH) in Hong Kong.
HIV-infected adults were recruited from a community-based Non-Governmental Organization (NGO) for HIV patient services. Participants were randomized into exercise group or control group. The participants in exercise group performed an 8-week moderate intensity supervised exercise program. In the control group, participants were not given any supervised exercises. They were advised to continue their routine daily activities and self exercises.
Outcomes were measured for both groups at baseline and after 8 weeks. Primary outcomes: grip strength, 30 seconds chair stand, 6 minutes-walk test and Short Form-36 questionnaire (SF-36). Secondary outcome: Subjective improvement
At the end of the program, all participants from exercise group were interviewed individually by principle investigator to allow feedbacks.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
It is a randomized controlled trial. HIV-infected adults were recruited from a community-based Non-Governmental Organization (NGO) for HIV patient services.They were randomized into exercise group or control group by drawing lots which contained equal number of orange balls (exercise) and white balls (control)
The participants in exercise group performed an 8-week, 2 times/week supervised exercise program in the community day center of the recruiting NGO. Exercise sessions were organized in a group of 2 to 3 participants. The exercises were supervised by a registered physiotherapist to ensure exercise safety and quality. Exercise intensity was moderate. We monitored the heart rate of participants during exercise and maintained around 50% to 70% of maximum heart rate. Blood pressure and oxygen saturation were also checked for safety purposes. The mode of exercise was combined aerobic and resistance training. It involved upper and lower limbs cycling, treadmill walking, multi-gym strengthening, stepper exercise, dumb bell and squatting exercise. The duration for each exercise session was around 45 minutes. Duration and intensity of exercises were adjusted depending on the tolerance and physical capacity of each participant. In the control group, participants were not given any supervised exercises. They were advised to continue their routine daily activities and self exercises. Control group participants were allowed to join into the same training program after the research had finished.
Outcomes were measured for both groups at baseline and after 8 weeks in the same community day center. A research assistant who was blinded for the participants grouping was responsible for data collection. Physical health parameters included grip strength, 30 seconds chair stand and 6 minutes-walk test. Health related quality of life was measured by Short Form-36 questionnaire (SF-36). Subjective improvement was taken in form of Likert scale, from -100% to +100% with 10% interval in each possible response.
At the end of the program, all participants from exercise group were interviewed individually by principle investigator to allow feedbacks.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Hong Kong, Hong Kong
- The Society for AIDS Care Day Centre
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Participants with HIV age > 50, treating with antiretroviral therapy
- No contraindication to moderate intensity exercise
- Independent Outdoor walker without assistance
- Sedentry participants who have not received any structural / supervised exercise program in the past 1 year
Exclusion Criteria:
- Age <50
- Unstable or unfit for exercise
- Wheelchair user or assisted walker
- Already had regular exercise habit or under structural exercise program in the past 1 year
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Exercise group
8-week moderate intensity exercise training under supervision
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Upper and lower limbs cycling, treadmill walking, multi-gym strengthening, stepper exercise, dumb bell and squatting exercise
|
Ingen indgriben: Control group
No supervised exercise training given.
Participants were advised to continue their routine daily activities and self exercises if they have
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change of SF-36 scores
Tidsramme: Change from Baseline SF-36 scores at 8 weeks
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Short Form 36 (SF-36) questionnaire is used to assess health related quality of life
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Change from Baseline SF-36 scores at 8 weeks
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Change of Grip strength
Tidsramme: Change from Baseline grip strength at 8 weeks
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Maximum grip strength of the participant in kg
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Change from Baseline grip strength at 8 weeks
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Change of 30 seconds chair stand
Tidsramme: Change from Baseline performance at 8 weeks
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Number of times that the participant stand up and sit down within 30 seconds
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Change from Baseline performance at 8 weeks
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Change of 6 minutes walk test
Tidsramme: Change from Baseline performance at 8 weeks
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The distance (in meters) which the participant is able to walk in 6 minutes
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Change from Baseline performance at 8 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Subjective improvement
Tidsramme: Subjective change after 8 weeks compare to baseline
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Subjective physical improvement reported by participant (from -100% to +100%)
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Subjective change after 8 weeks compare to baseline
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Chi Hong Chung, MSc, The Society for AIDS Care
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- supervised exercise
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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