NCT03748797

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2018

Completed
Last Updated

November 23, 2018

Status Verified

November 1, 2018

Enrollment Period

5 months

First QC Date

November 16, 2018

Last Update Submit

November 20, 2018

Conditions

Keywords

HIV, exercise, aging, physical health, quality of life

Outcome Measures

Primary Outcomes (4)

  • Change of SF-36 scores

    Short Form 36 (SF-36) questionnaire is used to assess health related quality of life

    Change from Baseline SF-36 scores at 8 weeks

  • Change of Grip strength

    Maximum grip strength of the participant in kg

    Change from Baseline grip strength at 8 weeks

  • Change of 30 seconds chair stand

    Number of times that the participant stand up and sit down within 30 seconds

    Change from Baseline performance at 8 weeks

  • Change of 6 minutes walk test

    The distance (in meters) which the participant is able to walk in 6 minutes

    Change from Baseline performance at 8 weeks

Secondary Outcomes (1)

  • Subjective improvement

    Subjective change after 8 weeks compare to baseline

Study Arms (2)

Exercise group

EXPERIMENTAL

8-week moderate intensity exercise training under supervision

Other: Moderate intensity exercise training under supervision

Control group

NO INTERVENTION

No supervised exercise training given. Participants were advised to continue their routine daily activities and self exercises if they have

Interventions

Upper and lower limbs cycling, treadmill walking, multi-gym strengthening, stepper exercise, dumb bell and squatting exercise

Exercise group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Society for AIDS Care Day Centre

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeMotor Activity

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBehavior

Study Officials

  • Chi Hong Chung, MSc

    The Society for AIDS Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
A research assistant who was blinded for the participants grouping was responsible for data collection.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Exercise group: Performed an 8-week, 2 times/week exercise training (moderate intensity) under physiotherapist supervision. Control group: No supervised exercise training given. Participants were advised to continue their routine daily activities and self exercises if they have.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

November 16, 2018

First Posted

November 21, 2018

Study Start

November 1, 2017

Primary Completion

March 31, 2018

Study Completion

March 31, 2018

Last Updated

November 23, 2018

Record last verified: 2018-11

Locations